Low Back PainNCT05384457
High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain
A study testing High intensity training and Moderate intensity training in people with Low Back Pain and Chronic Low-back Pain, run by Hasselt University at 1 site in Belgium.
Trial summary
This randomized controlled trial aims to investigate 1) the effects of high intensity training (HIT) compared to moderate intensity training (MIT) on diaphragm muscle strength, -endurance, -fatigue and -activation, 2) to which extent these changes in diaphragm functioning are related to changes in cardiorespiratory… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Chronic Low-back Pain, Chronic Pain
- What is being tested?
- High intensity training and Moderate intensity training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2022to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dutch-speaking
- Adults (age 18-65 years)
- Chronic low back pain (i.e. pain localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain for a period of at least twelve weeks), with a non-specific origin (i.e. pain of a nociceptive mechanical nature, not attributable to a recognizable, known, specific pathology, e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome)
- Dutch-speaking
- Adults (age 18-65 years)
- No acute or chronic complaints
Who cannot join
- History of spinal fusion
- A musculoskeletal disorder aside from chronic nonspecific low back pain that could affect the correct execution of the therapy program
- Baseline characteristics that could affect the evaluation of the outcomes (a pacemaker, a chronic obstructive respiratory disorder, or known balance/vestibular problems)
- Severe comorbidities (e.g., paresis or sensory disturbances of neurological origin, diabetes mellitus, rheumatoid arthritis)
- Ongoing compensation claims
- Negative advice from the general practitioner regarding sports medical screening
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- Pregnancy
- Persons that are not able to attend regular appointments
- History of spinal fusion
- Baseline characteristics that could affect the evaluation of the outcomes (a pacemaker, a chronic obstructive respiratory disorder, or known balance/vestibular problems)
- Severe comorbidities (e.g., paresis or sensory disturbances of neurological origin, diabetes mellitus, rheumatoid arthritis)
- Ongoing compensation claims
- Negative advice from the general practitioner regarding sports medical screening
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Diepenbeek, Limburg, 3590
Sim Klaps, +32(0)11268467, sim.klaps@uhasselt.be
About this study
Official title: The Breathe-(H)IT Trial: Multimodal High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain
This randomized controlled trial aims to investigate 1) the effects of high intensity training (HIT) compared to moderate intensity training (MIT) on diaphragm muscle strength, -endurance, -fatigue and -activation, 2) to which extent these changes in diaphragm functioning are related to changes in cardiorespiratory fitness, postural control, pain and disability after HIT versus MIT, 3) to which extent depressive mood and anxiety moderate the effects of HIT on diaphragm functioning in persons with chronic nonspecific low back pain (CNSLBP). The investigators hypothize that HIT improves diaphragm functioning more compared to MIT in persons with CNSLBP.
Read the detailed description
Low back pain is the number one cause of disability worldwide with important socio-economic implications. In Belgium, 7 out of 10 persons will suffer from low back pain during their life, and 29% of all sick leave days are due to it. Chronic low back pain is defined as persistent pain for a period of minimal 12 weeks. In 85-90% of the CLBP cases, the pain cannot be attributed to a definitive underlying pathoanatomical cause, and is therefore labelled as chronic nonspecific low back pain (CNSLBP).
International guidelines recommend exercise therapy as the first-choice treatment for CNSLBP. A crucial factor within this context is exercise intensity. Indeed, multimodal high intensity training (HIT) leads to higher improvements in disability and cardiorespiratory fitness compared to moderate intensity training (MIT) in persons with CNSLBP. However, the underlying mechanisms for the additional value of a HIT approach remain largely unknown. Interestingly, low back pain is associated with impairments in diaphragm function, as the diaphragm is not only a principal inspiratory muscle, but also plays an essential role in postural control. The latter is a key factor in the development and maintenance of CNSLBP.
In this randomized controlled trial, 64 persons with CNSLBP will be recruited through local distribution of flyers and adverts on social media. The sample size calculation is based on (1) the therapeutic effects of a 12-week HIT program (compared to a MIT program) on the maximal oxygen uptake (VO2max) in persons with CNSLBP and (2) the therapeutic effects of a 8-week high-intensity inspiratory muscle training program (compared to a low-intensity inspiratory muscle training program) on the maximal inspiratory pressure (MIP) in persons with CNSLBP. These outcomes were chosen as they relate to the respiratory system and are thus most fitting to indicate possible effects on diaphragm functioning. The sample size calculation is based on the requirement of a minimal clinically important difference of 3-3.5ml/kg/min (VO2max) and 17.2 H2O (MIP). The power calculation resulted in a total of 63 persons. Therefore, the investigators plan to recruit 64 patients.
Participants will be randomly assigned to a HIT program or a MIT program. Primary outcomes are diaphragm muscle strength, -endurance, -fatigue and - activation. Secondary outcomes are cardiorespiratory fitness, postural control, pain, disability, depressive mood and anxiety. Primary and secondary outcomes will be assessed at 5 timepoints (0 weeks, 6 weeks, 12 weeks, 3 months after intervention, 12 months after intervention).
To analyze the data, JMP Pro (15.2 SAS Institute Inc, Cary, USA) will be used. Descriptive statistics will be used to display baseline group characteristics. To evaluate between-group differences (i.e. the effectiveness of the HIT vs MIT intervention), a linear mixed model will be fitted with 'time' and 'group' as covariates, and incorporated random intercepts for the participants to account for the within-subject variation. To evaluate associations between diaphragm functioning and predictors/mediators for therapy success, correlations and multivariate regression analysis will be used.
- Conditions
- Low Back Pain, Chronic Low-back Pain, Chronic Pain
- Being tested
- High intensity training, Moderate intensity training
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity trainingOther
Participants will follow an exercise therapy program consisting of cardiorespiratory training, limb strength training and core muscle training.
Moderate intensity trainingOther
Participants will follow an exercise therapy program consisting of cardiorespiratory training, limb strength training and core muscle training.
| Study group | Role | What they receive |
|---|---|---|
| High intensity training (HIT) | Experimental | Each participant will follow 24 therapy sessions (2 x 1.5 hours/week). The experimental group will perform a multimodal HIT protocol. Cardiorespiratory training will consist of a high-intensity interval training protocol on a cycle ergometer. After a five-minute warm-up, interval training will start, consisting of five one-minute bouts (110 RPM at 100% VO2max workload), separated by one minute of active rest (75 RPM at 50% VO2max workload). Limb strength training will consist of a circuit of three upper-body (vertical traction, chest press, arm curl) and three lower-body exercises (leg curl, leg press, leg extension) executed at 80% of the one repetition maximum. Core muscle training will consist of a circuit of six static core exercises (glute bridge, glute clam, superman back extension, adapted plank, adapted side plank, shoulder retraction with hip hinge) at 60% of the maximal voluntary contraction. Receives: Other: High intensity training |
| Moderate intensity training (MIT) | Active comparator | Each participant will follow 24 therapy sessions (2 x 1.5 hours/week). The control group will perform a multimodal MIT protocol. Cardiorespiratory training will consist of a moderate-intensity continuous training protocol on a cycle ergometer. After a five-minute warm up, participants start continuous training comprising of 14 minutes of moderate-intensity cycling (90RPM at 60%VO2max workload). The duration will increase weekly with 1'40'' up to 22'40''. Limb strength training will consist of a circuit of three upper-body (vertical traction, chest press, arm curl) and three lower-body exercises (leg curl, leg press, leg extension) executed at 60% of the one repetition maximum. Core muscle training will be identical to the protocol described in 'Core muscle training HIT' with the exception of the exercise intensity. Only exercises with low relative core muscle activation will be used. Receives: Other: Moderate intensity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm strength
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP, and compared with reference values.
Measured: PRE (baseline)
Diaphragm strength
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Measured: MID (6 weeks)
Diaphragm strength
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Measured: POST (12 weeks)
Diaphragm strength
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Measured: FU1 (3 months follow-up)
Diaphragm strength
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Measured: FU2 (12 months follow-up)
Diaphragm endurance
Participants will undergo an inspiratory resistive loading protocol at a fixed intensity of 80% of MIP (POWERbreathe International Ltd., type KH2, Warwickshire, UK). The participants will be instructed to inhale maximally and as rapidly as possible at a frequency of 15 breaths/minute and a 0.5 duty cycle. The time to task failure will be recorded as the inspiratory muscle endurance time.
Measured: PRE (baseline)
Diaphragm endurance
Participants will undergo an inspiratory resistive loading protocol at a fixed intensity of 80% of MIP (POWERbreathe International Ltd., type KH2, Warwickshire, UK). The participants will be instructed to inhale maximally and as rapidly as possible at a frequency of 15 breaths/minute and a 0.5 duty cycle. The time to task failure will be recorded as the inspiratory muscle endurance time.
Measured: POST (12 weeks)
Diaphragm fatigue
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Measured: PRE (baseline)
Diaphragm fatigue
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer ((POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Measured: MID (6 weeks)
Diaphragm fatigue
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Measured: POST (12 weeks)
Diaphragm fatigue
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Measured: FU1 (3 months follow-up)
Diaphragm fatigue
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Measured: FU2 (12 months follow-up)
Diaphragm activation (amplitude)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: PRE (baseline)
Diaphragm activation (amplitude)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: MID (6 weeks)
Diaphragm activation (amplitude)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: POST (12 weeks)
Diaphragm activation (amplitude)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: FU1 (3 months follow-up)
Diaphragm activation (amplitude)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: FU2 (12 months follow-up)
Diaphragm activation (timing)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: PRE (baseline)
Diaphragm activation (timing)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: MID (6 weeks)
Diaphragm activation (timing)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: POST (12 weeks)
Diaphragm activation (timing)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: FU1 (3 months follow-up)
Diaphragm activation (timing)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Measured: FU2 (12 months follow-up)
Secondary outcomes (36)
Modified Oswestry Disability Index (MODI)
The Modified Oswestry Disability Index is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of ten items scored on a five-point scale. The total score is expressed in percentage (min. 0%, max. 100%) and displays the degree of functional limitation. A higher score indicates a higher degree of functional limitation.
Measured: PRE (baseline)
Modified Oswestry Disability Index (MODI)
The Modified Oswestry Disability Index is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of ten items scored on a five-point scale. The total score is expressed in percentage (min. 0%, max. 100%) and displays the degree of functional limitation. A higher score indicates a higher degree of functional limitation.
Measured: MID (6 weeks)
Modified Oswestry Disability Index (MODI)
The Modified Oswestry Disability Index is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of ten items scored on a five-point scale. The total score is expressed in percentage (min. 0%, max. 100%) and displays the degree of functional limitation. A higher score indicates a higher degree of functional limitation.
Measured: POST (12 weeks)
Modified Oswestry Disability Index (MODI)
The Modified Oswestry Disability Index is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of ten items scored on a five-point scale. The total score is expressed in percentage (min. 0%, max. 100%) and displays the degree of functional limitation. A higher score indicates a higher degree of functional limitation.
Measured: FU1 (3 months follow-up)
Modified Oswestry Disability Index (MODI)
The Modified Oswestry Disability Index is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of ten items scored on a five-point scale. The total score is expressed in percentage (min. 0%, max. 100%) and displays the degree of functional limitation. A higher score indicates a higher degree of functional limitation.
Measured: FU2 (12 months follow-up)
Brief Pain Inventory (BPI)
The Brief Pain Inventory assesses the severity of pain, its impact on functioning, the location of pain, pain medications, and the amount of pain relief in the past 24 hours. The body chart of this questionnaire will be used to record the extent of pain, using the pain drawing method. The extent of pain might indicate the presence of widespread pain, which has been associated with altered nociceptive pain processing in chronic joint pain. The BPI scale defines pain as follows:
- Worst Pain Score: 1 - 4 = Mild Pain
- Worst Pain Score: 5 - 6 = Moderate Pain
- Worst Pain Score: 7 - 10 = Severe Pain
Measured: PRE (baseline)
Brief Pain Inventory (BPI)
The Brief Pain Inventory assesses the severity of pain, its impact on functioning, the location of pain, pain medications, and the amount of pain relief in the past 24 hours. The body chart of this questionnaire will be used to record the extent of pain, using the pain drawing method. The extent of pain might indicate the presence of widespread pain, which has been associated with altered nociceptive pain processing in chronic joint pain. The BPI scale defines pain as follows:
- Worst Pain Score: 1 - 4 = Mild Pain
- Worst Pain Score: 5 - 6 = Moderate Pain
- Worst Pain Score: 7 - 10 = Severe Pain
Measured: MID (6 weeks)
Brief Pain Inventory (BPI)
The Brief Pain Inventory assesses the severity of pain, its impact on functioning, the location of pain, pain medications, and the amount of pain relief in the past 24 hours. The body chart of this questionnaire will be used to record the extent of pain, using the pain drawing method. The extent of pain might indicate the presence of widespread pain, which has been associated with altered nociceptive pain processing in chronic joint pain. The BPI scale defines pain as follows:
- Worst Pain Score: 1 - 4 = Mild Pain
- Worst Pain Score: 5 - 6 = Moderate Pain
- Worst Pain Score: 7 - 10 = Severe Pain
Measured: POST (12 weeks)
Brief Pain Inventory (BPI)
The Brief Pain Inventory assesses the severity of pain, its impact on functioning, the location of pain, pain medications, and the amount of pain relief in the past 24 hours. The body chart of this questionnaire will be used to record the extent of pain, using the pain drawing method. The extent of pain might indicate the presence of widespread pain, which has been associated with altered nociceptive pain processing in chronic joint pain. The BPI scale defines pain as follows:
- Worst Pain Score: 1 - 4 = Mild Pain
- Worst Pain Score: 5 - 6 = Moderate Pain
- Worst Pain Score: 7 - 10 = Severe Pain
Measured: FU1 (3 months follow-up)
Brief Pain Inventory (BPI)
The Brief Pain Inventory assesses the severity of pain, its impact on functioning, the location of pain, pain medications, and the amount of pain relief in the past 24 hours. The body chart of this questionnaire will be used to record the extent of pain, using the pain drawing method. The extent of pain might indicate the presence of widespread pain, which has been associated with altered nociceptive pain processing in chronic joint pain. The BPI scale defines pain as follows:
- Worst Pain Score: 1 - 4 = Mild Pain
- Worst Pain Score: 5 - 6 = Moderate Pain
- Worst Pain Score: 7 - 10 = Severe Pain
Measured: FU2 (12 months follow-up)
Beck Depression Inventory (BDI)
The Beck Depression Inventory is widely used as a self-reported questionnaire for assessing depression in patients with chronic pain. It consists of 21 items scored on a four-point scale (0-3). Item scores are summed to obtain the total score, with a higher total score indicating greater depression.
Measured: PRE (baseline)
Beck Depression Inventory (BDI)
The Beck Depression Inventory is widely used as a self-reported questionnaire for assessing depression in patients with chronic pain. It consists of 21 items scored on a four-point scale (0-3). Item scores are summed to obtain the total score, with a higher total score indicating greater depression.
Measured: POST (12 weeks)
Beck Depression Inventory (BDI)
The Beck Depression Inventory is widely used as a self-reported questionnaire for assessing depression in patients with chronic pain. It consists of 21 items scored on a four-point scale (0-3). Item scores are summed to obtain the total score, with a higher total score indicating greater depression.
Measured: FU2 (12 months follow-up)
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory is a questionnaire for assessing state anxiety (i.e. anxiety about an event) and trait anxiety (i.e. anxiety as a personal characteristic). It consists of 40 items scored on a four-point scale. Item scores are added to obtain the total score. The score of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-state and STAI-trait subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: PRE (baseline)
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory is a questionnaire for assessing state anxiety (i.e. anxiety about an event) and trait anxiety (i.e. anxiety as a personal characteristic). It consists of 40 items scored on a four-point scale. Item scores are added to obtain the total score. The score of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-state and STAI-trait subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: POST (12 weeks)
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory is a questionnaire for assessing state anxiety (i.e. anxiety about an event) and trait anxiety (i.e. anxiety as a personal characteristic). It consists of 40 items scored on a four-point scale. Item scores are added to obtain the total score. The score of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-state and STAI-trait subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: FU2 (12 months follow-up)
Relative proprioceptive weighting ratio
A force plate will measure center of pressure (COP) displacement in response to ankle and lumbar muscle vibration during upright standing. If a person relies on proprioception from the vibrated muscle, an illusion of loss of balance will occur. To compensate, participants will move their COP in the opposite direction. When the triceps surae muscles are vibrated, a postural sway in a backward direction is expected, whereas during lumbar paraspinal muscle vibration, a forward postural body sway is expected. The amount of COP displacement during local vibration may represent the extent to which a person makes use of the proprioceptive signals of the vibrated muscles to maintain the upright posture. Reliance on ankle vs. lumbar proprioception will be calculated as the Relative Proprioceptive Weighting (RPW) ratio: RPW= AbsAnkle/(AbsAnkle + AbsLumbar). 'AbsAnkle' and 'AbsLumbar' refer to the absolute COP displacement during ankle and lumbar muscle vibration, respectively.
Measured: PRE (baseline)
Relative proprioceptive weighting ratio
A force plate will measure center of pressure (COP) displacement in response to ankle and lumbar muscle vibration during upright standing. If a person relies on proprioception from the vibrated muscle, an illusion of loss of balance will occur. To compensate, participants will move their COP in the opposite direction. When the triceps surae muscles are vibrated, a postural sway in a backward direction is expected, whereas during lumbar paraspinal muscle vibration, a forward postural body sway is expected. The amount of COP displacement during local vibration may represent the extent to which a person makes use of the proprioceptive signals of the vibrated muscles to maintain the upright posture. Reliance on ankle vs. lumbar proprioception will be calculated as the Relative Proprioceptive Weighting (RPW) ratio: RPW= AbsAnkle/(AbsAnkle + AbsLumbar). 'AbsAnkle' and 'AbsLumbar' refer to the absolute COP displacement during ankle and lumbar muscle vibration, respectively.
Measured: MID (6 weeks)
Relative proprioceptive weighting ratio
A force plate will measure center of pressure (COP) displacement in response to ankle and lumbar muscle vibration during upright standing. If a person relies on proprioception from the vibrated muscle, an illusion of loss of balance will occur. To compensate, participants will move their COP in the opposite direction. When the triceps surae muscles are vibrated, a postural sway in a backward direction is expected, whereas during lumbar paraspinal muscle vibration, a forward postural body sway is expected. The amount of COP displacement during local vibration may represent the extent to which a person makes use of the proprioceptive signals of the vibrated muscles to maintain the upright posture. Reliance on ankle vs. lumbar proprioception will be calculated as the Relative Proprioceptive Weighting (RPW) ratio: RPW= AbsAnkle/(AbsAnkle + AbsLumbar). 'AbsAnkle' and 'AbsLumbar' refer to the absolute COP displacement during ankle and lumbar muscle vibration, respectively.
Measured: POST (12 weeks)
Relative proprioceptive weighting ratio
A force plate will measure center of pressure (COP) displacement in response to ankle and lumbar muscle vibration during upright standing. If a person relies on proprioception from the vibrated muscle, an illusion of loss of balance will occur. To compensate, participants will move their COP in the opposite direction. When the triceps surae muscles are vibrated, a postural sway in a backward direction is expected, whereas during lumbar paraspinal muscle vibration, a forward postural body sway is expected. The amount of COP displacement during local vibration may represent the extent to which a person makes use of the proprioceptive signals of the vibrated muscles to maintain the upright posture. Reliance on ankle vs. lumbar proprioception will be calculated as the Relative Proprioceptive Weighting (RPW) ratio: RPW= AbsAnkle/(AbsAnkle + AbsLumbar). 'AbsAnkle' and 'AbsLumbar' refer to the absolute COP displacement during ankle and lumbar muscle vibration, respectively.
Measured: FU1 (3 months follow-up)
Relative proprioceptive weighting ratio
A force plate will measure center of pressure (COP) displacement in response to ankle and lumbar muscle vibration during upright standing. If a person relies on proprioception from the vibrated muscle, an illusion of loss of balance will occur. To compensate, participants will move their COP in the opposite direction. When the triceps surae muscles are vibrated, a postural sway in a backward direction is expected, whereas during lumbar paraspinal muscle vibration, a forward postural body sway is expected. The amount of COP displacement during local vibration may represent the extent to which a person makes use of the proprioceptive signals of the vibrated muscles to maintain the upright posture. Reliance on ankle vs. lumbar proprioception will be calculated as the Relative Proprioceptive Weighting (RPW) ratio: RPW= AbsAnkle/(AbsAnkle + AbsLumbar). 'AbsAnkle' and 'AbsLumbar' refer to the absolute COP displacement during ankle and lumbar muscle vibration, respectively.
Measured: FU2 (12 months follow-up)
Thermal Detection and Pain Threshold Temperatures
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol.
Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the lower back) and remotely (at the contralateral wrist) using the TSA limits protocol:
- Cold Detection Threshold (CDT)
- Warmth Detection Threshold (WDT)
- Cold Pain Threshold (CPT)
- Heat Pain Threshold (HPT)
Measured: PRE (baseline)
Thermal Detection and Pain Threshold Temperatures
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol.
Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the lower back) and remotely (at the contralateral wrist) using the TSA limits protocol:
- Cold Detection Threshold (CDT)
- Warmth Detection Threshold (WDT)
- Cold Pain Threshold (CPT)
- Heat Pain Threshold (HPT)
Measured: MID (6 weeks)
Thermal Detection and Pain Threshold Temperatures
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol.
Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the lower back) and remotely (at the contralateral wrist) using the TSA limits protocol:
- Cold Detection Threshold (CDT)
- Warmth Detection Threshold (WDT)
- Cold Pain Threshold (CPT)
- Heat Pain Threshold (HPT)
Measured: POST (12 weeks)
Thermal Detection and Pain Threshold Temperatures
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol.
Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the lower back) and remotely (at the contralateral wrist) using the TSA limits protocol:
- Cold Detection Threshold (CDT)
- Warmth Detection Threshold (WDT)
- Cold Pain Threshold (CPT)
- Heat Pain Threshold (HPT)
Measured: FU1 (3 months follow-up)
Thermal Detection and Pain Threshold Temperatures
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol.
Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the lower back) and remotely (at the contralateral wrist) using the TSA limits protocol:
- Cold Detection Threshold (CDT)
- Warmth Detection Threshold (WDT)
- Cold Pain Threshold (CPT)
- Heat Pain Threshold (HPT)
Measured: FU2 (12 months follow-up)
Temporal Summation of Pain (TSP)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.
Measured: PRE (baseline)
Temporal Summation of Pain (TSP)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.
Measured: MID (6 weeks)
Temporal Summation of Pain (TSP)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.
Measured: POST (12 weeks)
Temporal Summation of Pain (TSP)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.
Measured: FU1 (3 months follow-up)
Temporal Summation of Pain (TSP)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.
Measured: FU2 (12 months follow-up)
Conditioned Pain Modulation (CPM)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli:
Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist.
Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus.
The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".
Measured: PRE (baseline)
Conditioned Pain Modulation (CPM)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli:
Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist.
Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus.
The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".
Measured: MID (6 weeks)
Conditioned Pain Modulation (CPM)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli:
Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist.
Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus.
The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".
Measured: POST (12 weeks)
Conditioned Pain Modulation (CPM)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli:
Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist.
Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus.
The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".
Measured: FU1 (3 months follow-up)
Conditioned Pain Modulation (CPM)
Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol.
Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli:
Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist.
Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus.
The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".
Measured: FU2 (12 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start22 Aug 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Maastricht University
- Responsible party
- Principal investigator, Annick Timmermans, Hasselt University
- Investigators
- Annick Timmermans, Principal investigator, REVAL-Rehabilitation Research Center, Hasselt University, Diepenbeek, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384457
- Sponsor's protocol ID
- B1152021000029
- Status last verified
- Oct 2022
- First submitted
- 11 May 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klaps S, Verbrugghe J, Goossens N, Van Wesemael S, Van Eecke B, Koke A, Verbunt J, Langer D, Janssens L, Timmermans A. Effects of high- versus moderate-intensity multimodal whole-body training to improve inspiratory muscle function in persons with chronic nonspecific low back pain. BMC Sports Sci Med Rehabil. 2026 Jun 9. doi: 10.1186/s13102-026-01773-y. Online ahead of print.
PubMed 42265781
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Breathe-(H)IT Trial: Multimodal High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT05384457
- Acronym / sponsor ID
- B1152021000029
- Conditions
- Low Back Pain, Chronic Low-back Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- KU Leuven, Maastricht University
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to investigate 1) the effects of high intensity training (HIT) compared to moderate intensity training (MIT) on diaphragm muscle strength, -endurance, -fatigue and -activation, 2) to which extent these changes in diaphragm functioning are related to changes in cardiorespiratory fitness, postural control, pain and disability after HIT versus MIT, 3) to which extent depressive mood and anxiety moderate the effects of HIT on diaphragm functioning in persons with chronic nonspecific low back pain (CNSLBP). The investigators hypothize that HIT improves diaphragm functioning more compared to MIT in persons with CNSLBP.
Detailed description
Low back pain is the number one cause of disability worldwide with important socio-economic implications. In Belgium, 7 out of 10 persons will suffer from low back pain during their life, and 29% of all sick leave days are due to it. Chronic low back pain is defined as persistent pain for a period of minimal 12 weeks. In 85-90% of the CLBP cases, the pain cannot be attributed to a definitive underlying pathoanatomical cause, and is therefore labelled as chronic nonspecific low back pain (CNSLBP).
International guidelines recommend exercise therapy as the first-choice treatment for CNSLBP. A crucial factor within this context is exercise intensity. Indeed, multimodal high intensity training (HIT) leads to higher improvements in disability and cardiorespiratory fitness compared to moderate intensity training (MIT) in persons with CNSLBP. However, the underlying mechanisms for the additional value of a HIT approach remain largely unknown. Interestingly, low back pain is associated with impairments in diaphragm function, as the diaphragm is not only a principal inspiratory muscle, but also plays an essential role in postural control. The latter is a key factor in the development and maintenance of CNSLBP.
In this randomized controlled trial, 64 persons with CNSLBP will be recruited through local distribution of flyers and adverts on social media. The sample size calculation is based on (1) the therapeutic effects of a 12-week HIT program (compared to a MIT program) on the maximal oxygen uptake (VO2max) in persons with CNSLBP and (2) the therapeutic effects of a 8-week high-intensity inspiratory muscle training program (compared to a low-intensity inspiratory muscle training program) on the maximal inspiratory pressure (MIP) in persons with CNSLBP. These outcomes were chosen as they relate to the respiratory system and are thus most fitting to indicate possible effects on diaphragm functioning. The sample size calculation is based on the requirement of a minimal clinically important difference of 3-3.5ml/kg/min (VO2max) and 17.2 H2O (MIP). The power calculation resulted in a total of 63 persons. Therefore, the investigators plan to recruit 64 patients.
Participants will be randomly assigned to a HIT program or a MIT program. Primary outcomes are diaphragm muscle strength, -endurance, -fatigue and - activation. Secondary outcomes are cardiorespiratory fitness, postural control, pain, disability, depressive mood and anxiety. Primary and secondary outcomes will be assessed at 5 timepoints (0 weeks, 6 weeks, 12 weeks, 3 months after intervention, 12 months after intervention).
To analyze the data, JMP Pro (15.2 SAS Institute Inc, Cary, USA) will be used. Descriptive statistics will be used to display baseline group characteristics. To evaluate between-group differences (i.e. the effectiveness of the HIT vs MIT intervention), a linear mixed model will be fitted with 'time' and 'group' as covariates, and incorporated random intercepts for the participants to account for the within-subject variation. To evaluate associations between diaphragm functioning and predictors/mediators for therapy success, correlations and multivariate regression analysis will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity training (HIT) | Experimental | Other: High intensity trainingEach participant will follow 24 therapy sessions (2 x 1.5 hours/week). The experimental group will perform a multimodal HIT protocol. Cardiorespiratory training will consist of a high-intensity interval training protocol on a cycle ergometer. After a five-minute warm-up, interval training will start, consisting of five one-minute bouts (110 RPM at 100% VO2max workload), separated by one minute of active rest (75 RPM at 50% VO2max workload). Limb strength training will consist of a circuit of three upper-body (vertical traction, chest press, arm curl) and three lower-body exercises (leg curl, leg press, leg extension) executed at 80% of the one repetition maximum. Core muscle training will consist of a circuit of six static core exercises (glute bridge, glute clam, superman back extension, adapted plank, adapted side plank, shoulder retraction with hip hinge) at 60% of the maximal voluntary contraction. |
| Moderate intensity training (MIT) | Active comparator | Other: Moderate intensity trainingEach participant will follow 24 therapy sessions (2 x 1.5 hours/week). The control group will perform a multimodal MIT protocol. Cardiorespiratory training will consist of a moderate-intensity continuous training protocol on a cycle ergometer. After a five-minute warm up, participants start continuous training comprising of 14 minutes of moderate-intensity cycling (90RPM at 60%VO2max workload). The duration will increase weekly with 1'40'' up to 22'40''. Limb strength training will consist of a circuit of three upper-body (vertical traction, chest press, arm curl) and three lower-body exercises (leg curl, leg press, leg extension) executed at 60% of the one repetition maximum. Core muscle training will be identical to the protocol described in 'Core muscle training HIT' with the exception of the exercise intensity. Only exercises with low relative core muscle activation will be used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Dutch-speaking
- Adults (age 18-65 years)
- Chronic low back pain (i.e. pain localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain for a period of at least twelve weeks), with a non-specific origin (i.e. pain of a nociceptive mechanical nature, not attributable to a recognizable, known, specific pathology, e.g. infection, tumour, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome)
- Dutch-speaking
- Adults (age 18-65 years)
Key exclusion criteria (14 listed)
- History of spinal fusion
- A musculoskeletal disorder aside from chronic nonspecific low back pain that could affect the correct execution of the therapy program
- Baseline characteristics that could affect the evaluation of the outcomes (a pacemaker, a chronic obstructive respiratory disorder, or known balance/vestibular problems)
- Severe comorbidities (e.g., paresis or sensory disturbances of neurological origin, diabetes mellitus, rheumatoid arthritis)
- Ongoing compensation claims
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity trainingParticipants will follow an exercise therapy program consisting of cardiorespiratory training, limb strength training and core muscle training. | Other | High intensity training (HIT) |
| Moderate intensity trainingParticipants will follow an exercise therapy program consisting of cardiorespiratory training, limb strength training and core muscle training. | Other | Moderate intensity training (MIT) |
Primary outcome
Diaphragm strength
Time frame: PRE (baseline)
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP, and compared with reference values.
Diaphragm strength
Time frame: MID (6 weeks)
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Diaphragm strength
Time frame: POST (12 weeks)
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Diaphragm strength
Time frame: FU1 (3 months follow-up)
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Diaphragm strength
Time frame: FU2 (12 months follow-up)
Maximal inspiratory pressure (MIP) is a reliable measure to quantify inspiratory muscle strength. MIP will be measured at residual volume according to the method of Black and Hyatt using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). A minimum of five repetitions will be performed, and tests will be repeated until there is less than 5% difference between the best and second-best test. The highest pressure sustained over 1 s will be defined as MIP.
Diaphragm endurance
Time frame: PRE (baseline)
Participants will undergo an inspiratory resistive loading protocol at a fixed intensity of 80% of MIP (POWERbreathe International Ltd., type KH2, Warwickshire, UK). The participants will be instructed to inhale maximally and as rapidly as possible at a frequency of 15 breaths/minute and a 0.5 duty cycle. The time to task failure will be recorded as the inspiratory muscle endurance time.
Diaphragm endurance
Time frame: POST (12 weeks)
Participants will undergo an inspiratory resistive loading protocol at a fixed intensity of 80% of MIP (POWERbreathe International Ltd., type KH2, Warwickshire, UK). The participants will be instructed to inhale maximally and as rapidly as possible at a frequency of 15 breaths/minute and a 0.5 duty cycle. The time to task failure will be recorded as the inspiratory muscle endurance time.
Diaphragm fatigue
Time frame: PRE (baseline)
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Diaphragm fatigue
Time frame: MID (6 weeks)
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer ((POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Diaphragm fatigue
Time frame: POST (12 weeks)
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Diaphragm fatigue
Time frame: FU1 (3 months follow-up)
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Diaphragm fatigue
Time frame: FU2 (12 months follow-up)
Diaphragm fatigue is defined as a reduction in the ability to produce force/pressure following contractile activity. First, MIP will be measured using an electronic pressure transducer (POWERbreathe International Ltd., type KH2, Warwickshire, UK). Then, the participant will perform a maximal cardiopulmonary exercise test (CPET). After the CPET, the MIP-measurement will be repeated. The difference between the MIP before and after the CPET will be used as a measure of diaphragm fatigue.
Diaphragm activation (amplitude)
Time frame: PRE (baseline)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (amplitude)
Time frame: MID (6 weeks)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (amplitude)
Time frame: POST (12 weeks)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (amplitude)
Time frame: FU1 (3 months follow-up)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (amplitude)
Time frame: FU2 (12 months follow-up)
Diaphragm activation will be measured in terms of electromyography (EMG) amplitude. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (timing)
Time frame: PRE (baseline)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (timing)
Time frame: MID (6 weeks)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (timing)
Time frame: POST (12 weeks)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (timing)
Time frame: FU1 (3 months follow-up)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
Diaphragm activation (timing)
Time frame: FU2 (12 months follow-up)
Diaphragm activation will be measured in terms of electromyography (EMG) timing. Surface EMG will be acquired throughout the postural control tasks and cardiopulmonary exercise test to measure muscle activation from the costal diaphragm/intercostals, scalene, parasternal intercostal, and sternocleidomastoid.
36 secondary outcomes
Modified Oswestry Disability Index (MODI)
Time frame: PRE (baseline)
Modified Oswestry Disability Index (MODI)
Time frame: MID (6 weeks)
Modified Oswestry Disability Index (MODI)
Time frame: POST (12 weeks)
Modified Oswestry Disability Index (MODI)
Time frame: FU1 (3 months follow-up)
Modified Oswestry Disability Index (MODI)
Time frame: FU2 (12 months follow-up)
Brief Pain Inventory (BPI)
Time frame: PRE (baseline)
Brief Pain Inventory (BPI)
Time frame: MID (6 weeks)
Brief Pain Inventory (BPI)
Time frame: POST (12 weeks)
Brief Pain Inventory (BPI)
Time frame: FU1 (3 months follow-up)
Brief Pain Inventory (BPI)
Time frame: FU2 (12 months follow-up)
Beck Depression Inventory (BDI)
Time frame: PRE (baseline)
Beck Depression Inventory (BDI)
Time frame: POST (12 weeks)
Beck Depression Inventory (BDI)
Time frame: FU2 (12 months follow-up)
State-Trait Anxiety Inventory (STAI)
Time frame: PRE (baseline)
State-Trait Anxiety Inventory (STAI)
Time frame: POST (12 weeks)
State-Trait Anxiety Inventory (STAI)
Time frame: FU2 (12 months follow-up)
Relative proprioceptive weighting ratio
Time frame: PRE (baseline)
Relative proprioceptive weighting ratio
Time frame: MID (6 weeks)
Relative proprioceptive weighting ratio
Time frame: POST (12 weeks)
Relative proprioceptive weighting ratio
Time frame: FU1 (3 months follow-up)
Relative proprioceptive weighting ratio
Time frame: FU2 (12 months follow-up)
Thermal Detection and Pain Threshold Temperatures
Time frame: PRE (baseline)
Thermal Detection and Pain Threshold Temperatures
Time frame: MID (6 weeks)
Thermal Detection and Pain Threshold Temperatures
Time frame: POST (12 weeks)
Thermal Detection and Pain Threshold Temperatures
Time frame: FU1 (3 months follow-up)
Thermal Detection and Pain Threshold Temperatures
Time frame: FU2 (12 months follow-up)
Temporal Summation of Pain (TSP)
Time frame: PRE (baseline)
Temporal Summation of Pain (TSP)
Time frame: MID (6 weeks)
Temporal Summation of Pain (TSP)
Time frame: POST (12 weeks)
Temporal Summation of Pain (TSP)
Time frame: FU1 (3 months follow-up)
Temporal Summation of Pain (TSP)
Time frame: FU2 (12 months follow-up)
Conditioned Pain Modulation (CPM)
Time frame: PRE (baseline)
Conditioned Pain Modulation (CPM)
Time frame: MID (6 weeks)
Conditioned Pain Modulation (CPM)
Time frame: POST (12 weeks)
Conditioned Pain Modulation (CPM)
Time frame: FU1 (3 months follow-up)
Conditioned Pain Modulation (CPM)
Time frame: FU2 (12 months follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Derived from this study: PubMed 42265781Klaps S, Verbrugghe J, Goossens N, Van Wesemael S, Van Eecke B, Koke A, Verbunt J, Langer D, Janssens L, Timmermans A. Effects of high- versus moderate-intensity multimodal whole-body training to improve inspiratory muscle function in persons with chronic nonspecific low back pain. BMC Sports Sci Med Rehabil. 2026 Jun 9. doi: 10.1186/s13102-026-01773-y. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annick Timmermans principal investigator
REVAL-Rehabilitation Research Center, Hasselt University, Diepenbeek, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity training and Moderate intensity training in people with Low Back Pain and Chronic Low-back Pain, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sim Klaps (+32(0)11268467, sim.klaps@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm strength (time frame: PRE (baseline)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.