Low Back PainLBP-HIT-RCTNCT02911987
Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain
A study testing high intensity training (HIT) program and moderate intensity training (MIT) exercise therapy in people with Low Back Pain, run by Hasselt University at 1 site in Belgium.
Trial summary
Low back pain is a common disorder, occurring worldwide in both males and females in all age groups. The prevalence is higher in females and the incidence peaks between 30 and 65 years. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- high intensity training (HIT) program and moderate intensity training (MIT) exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2016to Sep 2018
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- medically diagnosed with non-specific chronic low back pain,
- over 25 years old,
- Oswestry Disability Index: disability score >20%,
- able to understand Dutch (spoken and written),
- Physical Activities Scale For Individuals with Physical Disabilities <30. -
Who cannot join
- invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
- radiculopathy (uni- or bilateral),
- co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, an increase of pain of 3 points with a result of > 8/10 on the Numeric Pain Rating Scale (NPRS) in the last 48 hours, pregnancy,
- ongoing compensation claims and/or (work)disability > 6 months,
- rehabilitation/exercise therapy program for LBP in the past 6 months. -
Trial locations and contacts
1 site in 1 country.
Anouk Agten, drs. contact
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Hasselt, B-3500
Jonas Verbrugghe, drs., jonas.verbrugghe@uhasselt.be
About this study
Official title: Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial
Low back pain is a common disorder, occurring worldwide in both males and females in all age groups. The prevalence is higher in females and the incidence peaks between 30 and 65 years. It is currently the most frequent musculoskeletal cause of functional disability and it has a major socio-economic impact on today's society. Although a small percentage of persons with low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with low back pain present with symptoms of nonspecific origin. A part of these symptoms are only of short duration, but 23% of all people will develop nonspecific chronic low back pain (NSCLBP).
Exercise therapy (ET) is currently an important component in the treatment of NSCLBP. Previous studies analysed the effects of various modes of exercise therapy, such as motor control therapy, core stability training and aerobic conditioning training. However, therapy outcomes can be low, and guidelines in favour of using a specific program are contradictory. It thus still remains unclear which therapy modality is best suited. Furthermore, no recommendations are available about optimal training intensities during rehabilitation of persons with NSCLBP.
Read more
Since as well aerobic as muscular deconditioning are apparent in persons with chronic low back pain and improvements in overall physical fitness can affect therapy outcomes in this population, ET specifically focussing on physical fitness can be advocated for NSCLBP rehabilitation. High Intensity Training (HIT), has been promoted as an effective and efficient training method for improving physical fitness and health related parameters in healthy persons. Also, HIT resulted in successful reconditioning and improvement of functional and disease related outcomes in persons with other chronic diseases such as multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies showed promising results for the effect of HIT on low back pain such as high intensity isolated, evidence is still scarce and study results are unclear because of methodological shortcomings.
The aim of this randomized clinical trial study is to evaluate the effects of a HIT program on disease related outcomes, physical fitness and muscle contractile characteristics compared to a conventional rehabilitation program in persons with NSCLBP.
- Conditions
- Low Back Pain
- Being tested
- high intensity training (HIT) program, moderate intensity training (MIT) exercise therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity training (HIT) programOther
The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.
moderate intensity training (MIT) exercise therapyOther
MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group).
| Study group | Role | What they receive |
|---|---|---|
| the 'cardio' HIT group | Experimental | Group 1 receives HIT exercise, aimed only at improving cardiovascular endurance (the 'cardio' HIT group). Receives: Other: high intensity training (HIT) program |
| the 'general' HIT group | Experimental | Group 2 receives HIT exercise aimed at improving both cardiovascular and general muscle condition (the 'general' HIT group ). Receives: Other: high intensity training (HIT) program |
| the 'lumbar' HIT group | Experimental | Group 3 receives HIT exercise, aimed at improving both cardiovascular condition and specific trunk muscle condition (the 'lumbar' HIT group). Receives: Other: high intensity training (HIT) program |
| the 'combined' HIT group | Experimental | Group 4 receives HIT exercise which is a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'combined' HIT group). These trainings will take place in the REVAL Rehabilitation Research Center on the campus of Hasselt University in Diepenbeek. Receives: Other: high intensity training (HIT) program |
| control group | Active comparator | Group 5 receives MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group) Receives: Other: moderate intensity training (MIT) exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
The Numeric Pain Rating Scale (NPRS) is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant.
Measured: day 1
pain
The Numeric Pain Rating Scale (NPRS)
Measured: week 6
pain
The Numeric Pain Rating Scale (NPRS)
Measured: week 12
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.
Measured: day 1
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.
Measured: week 6
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.
Measured: week 12
Physical disability RMDQ
The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.
Measured: day 1
Physical disability RMDQ
The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.
Measured: week 6
Physical disability RMDQ
The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.
Measured: week 12
Endurance capacity
Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer
Measured: day 1
Endurance capacity
Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer
Measured: week 6
Endurance capacity
Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer
Measured: week 12
Abdominal/back strength
The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
Measured: day 1
Abdominal/back strength
The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
Measured: week 6
Abdominal/back strength
The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
Measured: week 12
Muscle Biopsy
muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.).
Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise.
Measured: day 1
Muscle Biopsy
muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.).
Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise.
Measured: week 12
Physical disability ODI
The Modified Oswestry Disability Index (ODI) 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 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.
Measured: day 1
Physical disability ODI
The Modified Oswestry Disability Index (ODI) 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 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.
Measured: week 6
Physical disability ODI
The Modified Oswestry Disability Index (ODI) 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 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.
Measured: week 12
activity level
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.
Measured: day 1
activity level
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.
Measured: week 6
activity level
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.
Measured: week 12
Secondary outcomes (14)
Body composition
The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.
Measured: day 1
Body composition
The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.
Measured: week 6
Body composition
The body composition is obtained by means of a dual Energy X-Ray Absorptiometry (DEXA) scan.
Measured: week 12
physical activity tracking
Activity of the daily routine will be evaluated by means of wearing an accelerometer (Actigraph GT3X activity monitors) (2 midweek days and 1 weekend day, 3 consecutive days) throughout the day. A schedule will be inventoried by the participant (diary).
Measured: day 1
physical activity tracking
Activity of the daily routine will be evaluated by means of wearing an accelerometer (Actigraph GT3X activity monitors) (2 midweek days and 1 weekend day, 3 consecutive days) throughout the day. A schedule will be inventoried by the participant (diary).
Measured: week 12
disability in participation and quality of life
Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each.
Measured: day 1
disability in participation and quality of life
Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each.
Measured: week 6
disability in participation and quality of life
Short Form Health Survey (SF-36) The SF-36 is a 36 item scale that assesses eight health concepts (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) with the possibility of independent scoring for each.
Measured: week 12
Motivation VAS
The start motivation is measured by a visual analog scale (VAS).
Measured: day 1
Motivation IMI
At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).
Measured: day 1
Motivation VAS
The start motivation is measured by a visual analog scale (VAS).
Measured: week 6
Motivation IMI
At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).
Measured: week 6
Motivation VAS
The start motivation is measured by a visual analog scale (VAS).
Measured: week 12
Motivation IMI
At the end of the study setting viewing detailed motivation for the program based on the Intrinsic Motivation Inventory (IMI) (on T1).
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Annick Timmermans, Hasselt University
- Investigators
- Annick Timmermans, prof. dr., Principal investigator, Hasselt UniversityFrank Vandenabeele, prof. dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911987
- Sponsor's protocol ID
- LBP-HIT-RCT
- Acronym
- LBP-HIT-RCT
- Status last verified
- Aug 2017
- First submitted
- 13 Sep 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Effects of High Intensity Training (HIT) Program in Patients With Non-specific Chronic Low Back Pain. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02911987
- Acronym / sponsor ID
- LBP-HIT-RCT / LBP-HIT-RCT
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Low back pain is a common disorder, occurring worldwide in both males and females in all age groups. The prevalence is higher in females and the incidence peaks between 30 and 65 years. It is currently the most frequent musculoskeletal cause of functional disability and it has a major socio-economic impact on today's society. Although a small percentage of persons with low back pain can be diagnosed with a specific underlying cause, almost 90% of persons with low back pain present with symptoms of nonspecific origin. A part of these symptoms are only of short duration, but 23% of all people will develop nonspecific chronic low back pain (NSCLBP).
Exercise therapy (ET) is currently an important component in the treatment of NSCLBP. Previous studies analysed the effects of various modes of exercise therapy, such as motor control therapy, core stability training and aerobic conditioning training. However, therapy outcomes can be low, and guidelines in favour of using a specific program are contradictory. It thus still remains unclear which therapy modality is best suited. Furthermore, no recommendations are available about optimal training intensities during rehabilitation of persons with NSCLBP.
Since as well aerobic as muscular deconditioning are apparent in persons with chronic low back pain and improvements in overall physical fitness can affect therapy outcomes in this population, ET specifically focussing on physical fitness can be advocated for NSCLBP rehabilitation. High Intensity Training (HIT), has been promoted as an effective and efficient training method for improving physical fitness and health related parameters in healthy persons. Also, HIT resulted in successful reconditioning and improvement of functional and disease related outcomes in persons with other chronic diseases such as multiple sclerosis, heart failure, COPD and cardiometabolic diseases. Although some studies showed promising results for the effect of HIT on low back pain such as high intensity isolated, evidence is still scarce and study results are unclear because of methodological shortcomings.
The aim of this randomized clinical trial study is to evaluate the effects of a HIT program on disease related outcomes, physical fitness and muscle contractile characteristics compared to a conventional rehabilitation program in persons with NSCLBP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| the 'cardio' HIT group | Experimental | Other: high intensity training (HIT) programGroup 1 receives HIT exercise, aimed only at improving cardiovascular endurance (the 'cardio' HIT group). |
| the 'general' HIT group | Experimental | Other: high intensity training (HIT) programGroup 2 receives HIT exercise aimed at improving both cardiovascular and general muscle condition (the 'general' HIT group ). |
| the 'lumbar' HIT group | Experimental | Other: high intensity training (HIT) programGroup 3 receives HIT exercise, aimed at improving both cardiovascular condition and specific trunk muscle condition (the 'lumbar' HIT group). |
| the 'combined' HIT group | Experimental | Other: high intensity training (HIT) programGroup 4 receives HIT exercise which is a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'combined' HIT group). These trainings will take place in the REVAL Rehabilitation Research Center on the campus of Hasselt University in Diepenbeek. |
| control group | Active comparator | Other: moderate intensity training (MIT) exercise therapyGroup 5 receives MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- medically diagnosed with non-specific chronic low back pain,
- over 25 years old,
- Oswestry Disability Index: disability score >20%,
- able to understand Dutch (spoken and written),
- Physical Activities Scale For Individuals with Physical Disabilities <30. -
Key exclusion criteria (5 listed)
- invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
- radiculopathy (uni- or bilateral),
- co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, an increase of pain of 3 points with a result of > 8/10 on the Numeric Pain Rating Scale (NPRS) in the last 48 hours, pregnancy,
- ongoing compensation claims and/or (work)disability > 6 months,
- rehabilitation/exercise therapy program for LBP in the past 6 months. -
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 training (HIT) programThe participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists. | Other | the 'cardio' HIT group, the 'combined' HIT group, the 'general' HIT group, the 'lumbar' HIT group |
| moderate intensity training (MIT) exercise therapyMIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group). | Other | control group |
Primary outcome
pain
Time frame: day 1
The Numeric Pain Rating Scale (NPRS) is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant.
pain
Time frame: week 6
The Numeric Pain Rating Scale (NPRS)
pain
Time frame: week 12
The Numeric Pain Rating Scale (NPRS)
Kinesiophobia
Time frame: day 1
The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.
Kinesiophobia
Time frame: week 6
The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.
Kinesiophobia
Time frame: week 12
The Tampa Scale for Kinesiophobia (TSK) is an ordinal 17 item questionnaire that inventories pain-related fear of movement for persons with subacute and chronic low back pain or fibromyalgia. A higher score relates to more pain-related fear.
Physical disability RMDQ
Time frame: day 1
The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.
Physical disability RMDQ
Time frame: week 6
The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.
Physical disability RMDQ
Time frame: week 12
The Roland Morris Disability Questionnaire (RMDQ) is an ordinal 24 item questionnaire for evaluating the disability level of the patient with low back pain with regards to activities of daily living. A higher score correlates to a higher level of disability and a change of 5 is the minimal clinically important difference.
Endurance capacity
Time frame: day 1
Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer
Endurance capacity
Time frame: week 6
Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer
Endurance capacity
Time frame: week 12
Endurance capacity is tested to volitional fatigue on an electronically braked bike ergometer
Abdominal/back strength
Time frame: day 1
The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
Abdominal/back strength
Time frame: week 6
The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
Abdominal/back strength
Time frame: week 12
The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
Muscle Biopsy
Time frame: day 1
muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.). Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise.
Muscle Biopsy
Time frame: week 12
muscle biopsies of the paravertebral muscles of the spine are obtained through a micro biopsy procedure (Biopsy gun, Bard Medical). This is done by a trained physician with extensive experience in taking muscle biopsies. The obtained muscle samples are divided into cryovials, per subject and per measurement (for the determination of muscle fiber CSA, muscle fiber characterization, distribution, angiogenesis, muscle fiber characteristics, etc.). Safety Issue: Yes, taking a piece of muscle tissue, can be slightly painful, but there are no serious risks involved. There will be no permanent damage to the muscle. The risk of infection in the wound can never be excluded. However, the site of the biopsy is thoroughly decontaminated and sealed in order to achieve a good wound healing and prevent an infection. A local bleeding may occur in the muscle causing a bruise.
Physical disability ODI
Time frame: day 1
The Modified Oswestry Disability Index (ODI) 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 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.
Physical disability ODI
Time frame: week 6
The Modified Oswestry Disability Index (ODI) 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 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.
Physical disability ODI
Time frame: week 12
The Modified Oswestry Disability Index (ODI) 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 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.
activity level
Time frame: day 1
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.
activity level
Time frame: week 6
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.
activity level
Time frame: week 12
Physical Activities Scale For Individuals with Physical Disabilities (PASIPD) The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.
14 secondary outcomes
Body composition
Time frame: day 1
Body composition
Time frame: week 6
Body composition
Time frame: week 12
physical activity tracking
Time frame: day 1
physical activity tracking
Time frame: week 12
disability in participation and quality of life
Time frame: day 1
disability in participation and quality of life
Time frame: week 6
disability in participation and quality of life
Time frame: week 12
Motivation VAS
Time frame: day 1
Motivation IMI
Time frame: day 1
Motivation VAS
Time frame: week 6
Motivation IMI
Time frame: week 6
Motivation VAS
Time frame: week 12
Motivation IMI
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Anouk Agten, drs. contact
Annick Timmermans, prof. dr. principal investigator
Hasselt University
Frank Vandenabeele, prof. dr. principal investigator
Hasselt University
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 (HIT) program and moderate intensity training (MIT) exercise therapy in people with 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 5 inclusion and 5 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 9 Aug 2017. 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 Jonas Verbrugghe, drs. (+ 32 11 26 92 39, jonas.verbrugghe@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: day 1). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2017.