COPDNCT03101774
Inspiratory Muscle Training on Respiratory Muscle Function，Quality of Life and Exercise Capacity in Stable COPD
A study testing Threshold inspiratory muscle training and Resistive inspiratory muscle training in people with COPD, run by Guangzhou Institute of Respiratory Disease.
Trial summary
Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT device in different operation principle in COPD are so far lacking. Therefore the investigators perform an adequately powered RCT on the effects of two IMT device application as an pulmonary physical therapy in patients with COPD… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Threshold inspiratory muscle training and Resistive inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Mar 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value (GOLD C and D group);
- Inspiratory muscle weakness（Maximal Inspiratory Pressure under 60cmH2O）;
- Bronchial dilation test (BDT) negative;
- No history of pulmonary rehabilitation.
Who cannot join
- severe orthopaedic problems having a major impact on daily activities;
- previous inclusion in rehabilitation programme (<1 year);
- diagnosed psychiatric or cognitive disorders
- progressive neurological or neuromuscular disorders.
About this study
Official title: Effects of Respiratory Physiology-oriented Inspiratory Muscle Training on Respiratory Muscle Function，Quality of Life and Exercise Capacity in Stable COPD With Inspiratory Muscle Weakness: a Randomised Controlled Trial
Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT device in different operation principle in COPD are so far lacking. Therefore the investigators perform an adequately powered RCT on the effects of two IMT device application as an pulmonary physical therapy in patients with COPD with inspiratory muscle weakness.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is defined as sustained expiratory flow limitation small airway disease which is a major cause of morbidity and mortality worldwide. Dyspnoea is the most vital symptom lead to exercise-limiting of COPD which is the major reason of physical activities reduction and consequently contribute to dysfunction of skeletal muscle including diaphragm. Diaphragm sarcopenia is well documented as an important extrapulmonary manifestation of COPD. It has been suggested that reductions in exercise capacity are conversely related to the muscle weakness present in these patients and consequently impact negatively on quality of life. It also contributes to hypoxaemia and hypercapnia in progressive stage.
Mutiple pulmonary rehabilitation programs are regular physical care for stable patients with COPD to improve extrapulmonary disease manifestations. Inspiratory muscle training (IMT) serve as one of pulmonary rehabilitation program that aim at diaphragmatic improvement has been used constantly and is extensively studied in recent years in stable patients with COPD.
From meta-analyses of randomised controlled trials (RCTs) in patients with COPD, it can been concluded that IMT as a stand-alone therapy was proved to increase inspiratory muscle strength and endurance, decrease dyspnea, improve exercise capacity and the quality of life. It was also concluded that COPD patients with inspiratory muscle weakness which defined as PI,max< 60 cmH2O were more likely to significantly improve inspiratory muscle strength and functional exercise capacity when IMT was applied.
IMT is defined as persistent breathing training using the inspiratory training device. Inspiratory muscle trainers were classified into inspiratory resistive trainers® and inspiratory threshold trainers® according to operation principle. The former contain build-in spring-loaded valve which provides a continuous, pre-determined inspiratory load during the entire inspiratory phase; The latter do not provide a constant inspiratory load to ensure the intensity of inspiratory training. There are great differences in operation principle between the two inspiratory muscle trainers above. Inspiratory resistance that generated by inspiratory resistive trainers depend on inspiratory flow rate, however threshold load is independent of inspiratory flow. Intensity of loads in the two IMT devices can be repectively adjust.
However, therapic effect of IMT remains undefined due to disunity of IMT devices and loads in previous studies. Various devices and loads arouses different training intensity which is the key point of securing training effect. The optimized IMT program with proper devices and loads should be figure out. The investigators' previous study elaborated the detailed respiratory physiological response to IMT in COPD. Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT device in different operation principle in COPD are so far lacking. Therefore the investigators perform an adequately powered RCT on the effects of two IMT device application as an pulmonary physical therapy in patients with COPD with inspiratory muscle weakness.
- Conditions
- COPD
- Being tested
- Threshold inspiratory muscle training, Resistive inspiratory muscle training, Control group
- Keywords
- inspiratory muscle training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold inspiratory muscle trainingDevice
Threshold inspiratory muscle training device (Threshold Inspiration Muscle Trainer, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week.
Resistive inspiratory muscle trainingDevice
Resistive inspiratory muscle training device(PFLEX, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week.
Control groupOther
Conventional therapy without any inspiratory muscle training program
| Study group | Role | What they receive |
|---|---|---|
| threshold-IMT group | Experimental | Using inspiratory muscle training using threshold load device for 8 weeks Receives: Device: Threshold inspiratory muscle training |
| resisive-IMT group | Experimental | Using inspiratory muscle training using resistive device for 8 weeks Receives: Device: Resistive inspiratory muscle training |
| control group | Sham comparator | not conduct inspiratory muscle training for 8 weeks Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle force
Maximal inspiratory pressure measurement is a test of inspiratory muscle force. The measurement of maximal inspiratory pressure reflects the strength generated by the entire inspiratory muscles. Patients were normally seated and strongly urged to make maximum inspiratory efforts at residual volume(RV). The maximum pressure value of mouthpiece was measured during the maximal inspiratory maneuvers. The maximum value of three satisfactory manipulation that vary by less than 20% was recorded. Unit of maximal inspiratory pressure measurement is cmH2O (centimeter water column) as a pressure unit.
Measured: 8 weeks
Secondary outcomes (4)
Health-related quality of life
The Chronic Respiratory Disease Questionnaire (CRQ) will be used to assess Health-related Quality of Life(HRQL). This 20-item interviewer-administered questionnaire, which takes about 20 minutes to complete, has a total score and four domain scores (dyspnea, fatigue, emotion, and mastery-the sense of control over the disease). Each item score is 1-7 points, and total score is 20-140 points.
Measured: 8 weeks
degree of dyspnea
The BDI (baseline dyspnea index) and TDI (transition dyspnea index) are interviewer-administered questionnaires that assess dyspnea through its effect on daily activities. The instrument takes about 3 to 4 minutes to complete. The BDI has three scales: functional impairment, magnitude of task, and magnitude of effort. Each is scored on a 0 (severe) to 4 (no impairment) scale. The total score, which sums the three, can therefore range from zero (most limitation from dyspnea) to 12 (no limitation from dyspnea). Changes in limitation in the areas of functional impairment, magnitude of task, and magnitude of effort are rated with the TDI. Each is scored on a -3(major deterioration) to 0(no change) to +3(major improvement) scale.The focal TDI score,which sums the three, therefore, can range from -9(greatest increase in limitation owing to dyspnea)to +9 (greatest reduction in limitation owing to dyspnea).
Measured: 8 weeks
blood gas analysis
Carbon dioxide partial pressure（millimeters of mercury，mmHg） and oxygen saturation（%） were detected and analyzed.
Measured: 8 weeks
Maximal exercise capacity (incremental cardiopulmonary exercise testing)
The maximal incremental exercise tests were conducted on an electrically braked cycle ergometer (Ergoselect 200 K; Cosmed, Rome, Italy) . Symptom-limited-cycle exercise test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min; the exercise load was increased by 10 Watt each minute, end up while symptom-limited appear. Maximal exercise capacity indexes were analyzed after recording, mainly including the following: endurance exercise capacity(second, s); maximum work(Wmax [Watt, W]) , maximum oxygen uptake (V'O2,max [liter per minute, L/min]), maximum oxygen uptake per kilogram (V'O2,max [milliliters per minute per kilogram, mL/min/kg]), maximal minute ventilation (V'E,max [milliliters per minute, L/min]), carbon dioxide equivalent (V'E/VCO2 [equivalent]).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Jan 2016
- Primary completion1 Feb 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiliang Wu, Guangzhou Institute of Respiratory Disease
- Investigators
- Rongchang Chen, Prof, Study chair, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101774
- Sponsor's protocol ID
- GuangzhouInsRD
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Physiology-oriented Inspiratory Muscle Training on Respiratory Muscle Function，Quality of Life and Exercise Capacity in Stable COPD With Inspiratory Muscle Weakness: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03101774
- Acronym / sponsor ID
- GuangzhouInsRD
- Conditions
- COPD
- Keywords
- inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 5 Apr 2017 (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.
Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT device in different operation principle in COPD are so far lacking. Therefore the investigators perform an adequately powered RCT on the effects of two IMT device application as an pulmonary physical therapy in patients with COPD with inspiratory muscle weakness.
Detailed description
Chronic obstructive pulmonary disease (COPD) is defined as sustained expiratory flow limitation small airway disease which is a major cause of morbidity and mortality worldwide. Dyspnoea is the most vital symptom lead to exercise-limiting of COPD which is the major reason of physical activities reduction and consequently contribute to dysfunction of skeletal muscle including diaphragm. Diaphragm sarcopenia is well documented as an important extrapulmonary manifestation of COPD. It has been suggested that reductions in exercise capacity are conversely related to the muscle weakness present in these patients and consequently impact negatively on quality of life. It also contributes to hypoxaemia and hypercapnia in progressive stage.
Mutiple pulmonary rehabilitation programs are regular physical care for stable patients with COPD to improve extrapulmonary disease manifestations. Inspiratory muscle training (IMT) serve as one of pulmonary rehabilitation program that aim at diaphragmatic improvement has been used constantly and is extensively studied in recent years in stable patients with COPD.
From meta-analyses of randomised controlled trials (RCTs) in patients with COPD, it can been concluded that IMT as a stand-alone therapy was proved to increase inspiratory muscle strength and endurance, decrease dyspnea, improve exercise capacity and the quality of life. It was also concluded that COPD patients with inspiratory muscle weakness which defined as PI,max< 60 cmH2O were more likely to significantly improve inspiratory muscle strength and functional exercise capacity when IMT was applied.
IMT is defined as persistent breathing training using the inspiratory training device. Inspiratory muscle trainers were classified into inspiratory resistive trainers® and inspiratory threshold trainers® according to operation principle. The former contain build-in spring-loaded valve which provides a continuous, pre-determined inspiratory load during the entire inspiratory phase; The latter do not provide a constant inspiratory load to ensure the intensity of inspiratory training. There are great differences in operation principle between the two inspiratory muscle trainers above. Inspiratory resistance that generated by inspiratory resistive trainers depend on inspiratory flow rate, however threshold load is independent of inspiratory flow. Intensity of loads in the two IMT devices can be repectively adjust.
However, therapic effect of IMT remains undefined due to disunity of IMT devices and loads in previous studies. Various devices and loads arouses different training intensity which is the key point of securing training effect. The optimized IMT program with proper devices and loads should be figure out. The investigators' previous study elaborated the detailed respiratory physiological response to IMT in COPD. Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT device in different operation principle in COPD are so far lacking. Therefore the investigators perform an adequately powered RCT on the effects of two IMT device application as an pulmonary physical therapy in patients with COPD with inspiratory muscle weakness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| threshold-IMT group | Experimental | Device: Threshold inspiratory muscle trainingUsing inspiratory muscle training using threshold load device for 8 weeks |
| resisive-IMT group | Experimental | Device: Resistive inspiratory muscle trainingUsing inspiratory muscle training using resistive device for 8 weeks |
| control group | Sham comparator | Other: Control groupnot conduct inspiratory muscle training for 8 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value (GOLD C and D group);
- Inspiratory muscle weakness（Maximal Inspiratory Pressure under 60cmH2O）;
- Bronchial dilation test (BDT) negative;
- No history of pulmonary rehabilitation.
Key exclusion criteria (4 listed)
- severe orthopaedic problems having a major impact on daily activities;
- previous inclusion in rehabilitation programme (<1 year);
- diagnosed psychiatric or cognitive disorders
- progressive neurological or neuromuscular disorders.
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 |
|---|---|---|
| Threshold inspiratory muscle trainingThreshold inspiratory muscle training device (Threshold Inspiration Muscle Trainer, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week. | Device | threshold-IMT group |
| Resistive inspiratory muscle trainingResistive inspiratory muscle training device(PFLEX, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week. | Device | resisive-IMT group |
| Control groupConventional therapy without any inspiratory muscle training program | Other | control group |
Primary outcome
Respiratory muscle force
Time frame: 8 weeks
Maximal inspiratory pressure measurement is a test of inspiratory muscle force. The measurement of maximal inspiratory pressure reflects the strength generated by the entire inspiratory muscles. Patients were normally seated and strongly urged to make maximum inspiratory efforts at residual volume(RV). The maximum pressure value of mouthpiece was measured during the maximal inspiratory maneuvers. The maximum value of three satisfactory manipulation that vary by less than 20% was recorded. Unit of maximal inspiratory pressure measurement is cmH2O (centimeter water column) as a pressure unit.
4 secondary outcomes
Health-related quality of life
Time frame: 8 weeks
degree of dyspnea
Time frame: 8 weeks
blood gas analysis
Time frame: 8 weeks
Maximal exercise capacity (incremental cardiopulmonary exercise testing)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
Rongchang Chen, Prof study chair
Guangzhou Institute of Respiratory Disease
Questions about this trial
What is this clinical trial studying?
A study testing Threshold inspiratory muscle training and Resistive inspiratory muscle training in people with COPD, run by Guangzhou Institute of Respiratory Disease.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle force (time frame: 8 weeks). 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 5 Apr 2017.