COPDIMTCOCOPDNCT01900873
Effects of Inspiratory Muscle Training on Dyspnea Perception During Exercise in Patients With COPD
A study testing Inspiratory Muscle Strength Training and Inspiratory Muscle Endurance Training in people with COPD and Severe Systemic Illness-induced Respiratory Muscle Wasting, run by KU Leuven at 1 site in Canada.
Trial summary
Patients with chronic obstructive pulmonary disease are often limited in their exercise capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung volumes during exercise which forces inspiratory muscles to work at a high percentage of their maximal capacity. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD, Severe Systemic Illness-induced Respiratory Muscle Wasting
- What is being tested?
- Inspiratory Muscle Strength Training and Inspiratory Muscle Endurance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Sep 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of COPD
- Inspiratory Muscle Weakness (Pi,max < 70cmH2O or < 70% predicted)
Who cannot join
- Major cardiovascular, orthopedic, or cognitive impairments limiting exercise capacity more than pulmonary function impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with chronic obstructive pulmonary disease are often limited in their exercise capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung volumes during exercise which forces inspiratory muscles to work at a high percentage of their maximal capacity. This increased inspiratory effort has been shown to be independently related to symptoms of dyspnea during exercise in previous research. Eight weeks of high intensity variable flow resistive inspiratory muscle training is hypothesized to reduce inspiratory effort and to decrease neural drive to inspiratory muscles. These factors are hypothesized to jointly contribute to delaying the occurrence of intolerable symptoms of dyspnea and to improve exercise tolerance in these patients.
Read the detailed description
We want to study whether a highly intense inspiratory muscle training program improves exercise capacity by reducing inspiratory effort, improving pulmonary mechanics and delaying the development of intolerable symptoms of dyspnea during cycle exercise. Eight weeks of high intensity variable flow resistive inspiratory muscle training is hypothesized to reduce inspiratory effort and to decrease neural drive to inspiratory muscles. The ratio of inspiratory effort to volume displacement should improve, and reductions of inspiratory capacity during exercise should be delayed. These factors are hypothesized to jointly contribute in delaying the occurrence of intolerable symptoms of dyspnea and to improve exercise tolerance in these patients.
We will study physiological mechanisms by which inspiratory muscle training exerts its effects on dyspnea reduction and exercise capacity. In this clinical trial patients will be randomly allocated into either an intervention or a control group. The intervention group will receive a highly intense inspiratory muscle training program that will improve inspiratory muscle function. The control group will receive a sham training that will not result in physiological benefits.
During the 8-week training period patients will have to attend the hospital once weekly for a short visit to perform a training session under supervision. Before the training intervention patients will be assessed twice and then again once after the 8-week program. This means that this trial will involve a total of 11 visits (3 long visits (approximately 4h) for assessments and 8 short visits (approximately 30 minutes) for supervised training sessions) over a period of 2-3 months. Assessments of pulmonary function, inspiratory muscle function, exercise capacity, daily physical activity and symptoms of dyspnea during exercise will be performed. Pulmonary mechanics and inspiratory muscle activation during exercise will also be assessed.
Stable COPD patients with pronounced inspiratory muscle weakness (Pi,max < 70cmH2O or <70% predicted) will be eligible to participate in the study. Exclusion criteria will be diagnosed psychiatric or cognitive disorders, progressive neurological or neuromuscular disorders and severe orthopedic problems having a major impact on exercise capacity.
Patients in both the intervention and the placebo group will follow an eight-week IMT program. They will receive either high intensity IMT (intervention group) or sham IMT (placebo group). Interventions will be presented to patients as strength training (intervention group) or endurance training (placebo group). Measurements of primary and secondary endpoints will be performed before and after 8 weeks of IMT. All tests will be performed by an experienced investigator that will be blinded to group allocation.
Total training load for both groups will be two to three daily sessions of 30 breaths (3-4 minutes per session), on 7 days per week, for 8 weeks. IMT will be performed using a variable flow resistive loading device(POWERbreathe®KH1, HaB International Ltd., Southam, UK).
Differences in primary and secondary outcomes between groups after 8 weeks of IMT will be compared adjusting for baseline differences in an analysis of covariance (ANCOVA).
Dyspnea perception on a 10-point Borg Scale (BORG CR10) at identical ventilation during the constant work rate cycling test after the intervention will be the primary outcome. To detect a difference of one point in the dyspnea perception on a 10-point Borg Scale at identical ventilation during the constant work rate cycling test after the intervention between subjects, assuming a standard deviation of the changes in dyspnea perception between baseline and follow-up measurement of 1 point with a degree of certainty (statistical power) of 80% and a risk for a type I error (a) < 5%, a sample size of 16 patients for each group is needed. These estimates are based on previous work on dyspnea perceptions during exercise.
- Being tested
- Inspiratory Muscle Strength Training, Inspiratory Muscle Endurance Training
- Keywords
- Inspiratory Muscle Training, COPD, Inspiratory Muscle Function, Dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Strength TrainingDevice
Also called Electronic Variable Flow Resistive Loading IMT Device, POWERbreathe®KH1, HaB International Ltd., Southam, UK
IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The intervention group (strength IMT) will perform two daily sessions of 30 breaths. Measurements of Pi,max will be performed every week and training loads will be increased continuously to maintain at least 40-50% of the actual Pi,max values. Each week, one training session will be performed under supervision. Training load will be increased during this session.
Inspiratory Muscle Endurance TrainingDevice
Also called Electronic Variable Flow Resistive Loading IMT Device, POWERbreathe®KH1, HaB International Ltd., Southam, UK
IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The sham group (endurance IMT) will perform three daily sessions of 30 breaths and will train at a constant inspiratory load of no more than 10% of their initial Pi,max. Each week, one training session will be performed under supervision.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | High intensity inspiratory muscle training Receives: Device: Inspiratory Muscle Strength Training |
| Inspiratory Muscle Endurance Training | Sham comparator | Sham inspiratory muscle training at low intensity Receives: Device: Inspiratory Muscle Endurance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea (Borg CR-10 scale)
Numerical value reported for intensity of dyspnea (shortness of breath) ranging from 0 (no symptoms) to 10 (maximal symptoms)
Measured: Change from Baseline in Borg CR-10 scale at 8 weeks
Secondary outcomes (6)
Maximal inspiratory pressure (Pi,max)
Maximal voluntary inspiratory pressure will be recorded at the mouth to assess inspiratory muscle strength (pressure generating capacity). Measurements will be performed at functional residual capacity for inspiratory respiratory pressure (maximal inspiratory pressure; Pi,max ) using the technique proposed by Black and Hyatt. (Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis 1969;99:696-702.) An electronic pressure transducer will be used (MicroRPM; Micromedical, Kent, UK) to register pressures. Reference values published by Rochester and Arora will be used to define percentages of normal respiratory muscle pressures. (Rochester DF, Arora NS. Respiratory muscle failure. Med Clin North Am 1983;67:573-97.)
Measured: Change from Baseline in Pi,max at 8 weeks
Inspiratory Muscle Endurance during a constant load breathing task
To measure inspiratory muscle endurance patients will be asked to breathe against a submaximal inspiratory load provided by a flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK) until task failure. An inspiratory load will be selected that allows patients to continue breathing against the resistance for 3-7 minutes (typically between 50-60% of the Pi,max). Breathing instructions for patients will be the same as during the training sessions. Number of breaths, average duty cycle (inspiratory time as a fraction of the total respiratory cycle), average load, average power, and total work will be registered during the test by the handheld loading device. After 8 weeks of IMT the test will be repeated against an identical load and improvements in endurance time (seconds) will be registered as the main outcome. Changes in breathing parameters will be also registered.
Measured: Change from Baseline in endurance time at 8 weeks
Endurance capacity during a constant load cycling exercise test
Endurance exercise testing will be conducted on an electronically braked cycle ergometer (Ergometrics 800S; SensorMedics, Anaheim, CA). This test will be performed at 75% of the peak work rate achieved during an incremental exercise test. Patients will be encouraged to continue exercising for as long as possible and upon exercise cessation they will be asked to verbalize their main reason for stopping exercise. Subjects will rate the magnitude of their perceived breathing and leg effort at rest, every 2 minutes during exercise and at end exercise by pointing to a 10-point Borg scale. Patients will also have to complete a questionnaire on descriptors of breathlessness at the end of the test. The test will be repeated against an identical intensity at the end of the training program. Changes in endurance time (sec) will be the main outcome.
Measured: Change from Baseline in endurance time at 8 weeks
Pulmonary Function
Pulmonary function Spirometry and whole body plethysmography will be performed according to the European Respiratory Society guidelines for pulmonary function testing (Vmax Autobox, Sensor Medics, Bilthoven, the Netherlands). (Quanjer PH, Tammeling GJ, Cotes JE, et al. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl 1993;16:5-40.) Changes in FEV1 (L), FVC (L), FRC (L), RV (L), IC (L) and peak inspiratory flow (L/s) will be registered.
Measured: Change from Baseline in Pulmonary Function parameters at 8 weeks
Daily Physical Activity
Assessed with the SenseWear Pro3 activity monitor
Measured: Change in daily steps and time in moderate to vigorous daily physical activity from Baseline at 8 weeks
Health related Quality of Life
Assessed with the Saint George Respiratory Questionnaire (SGRQ)
Measured: Change from Baseline in health related quality of life at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
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 COPDStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario
- Responsible party
- Principal investigator, Daniel Langer, KU Leuven
- Investigators
- Daniel Langer, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900873
- Sponsor's protocol ID
- DMED-1579-13
- Acronym
- IMTCOCOPD
- Status last verified
- Feb 2015
- First submitted
- 10 Jul 2013
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klaps S, Langer D, Gosselink R, Dacha S, Louvaris Z, Jacobs N, Janssens W, Janssens L. The value of extra-diaphragmatic inspiratory muscle surface electromyography during postural control tasks in patients with chronic obstructive pulmonary disease. Respir Med. 2025 Jul;243:108127. doi: 10.1016/j.rmed.2025.108127. Epub 2025 Apr 25.
PubMed 40288657
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Dyspnea Perception During Exercise in Patients With COPD
- ClinicalTrials.gov ID
- NCT01900873
- Acronym / sponsor ID
- IMTCOCOPD / DMED-1579-13
- Keywords
- Inspiratory Muscle Training, COPD, Inspiratory Muscle Function, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Queen's University, Kingston, Ontario
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Jul 2013 (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.
Patients with chronic obstructive pulmonary disease are often limited in their exercise capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung volumes during exercise which forces inspiratory muscles to work at a high percentage of their maximal capacity. This increased inspiratory effort has been shown to be independently related to symptoms of dyspnea during exercise in previous research. Eight weeks of high intensity variable flow resistive inspiratory muscle training is hypothesized to reduce inspiratory effort and to decrease neural drive to inspiratory muscles. These factors are hypothesized to jointly contribute to delaying the occurrence of intolerable symptoms of dyspnea and to improve exercise tolerance in these patients.
Detailed description
We want to study whether a highly intense inspiratory muscle training program improves exercise capacity by reducing inspiratory effort, improving pulmonary mechanics and delaying the development of intolerable symptoms of dyspnea during cycle exercise. Eight weeks of high intensity variable flow resistive inspiratory muscle training is hypothesized to reduce inspiratory effort and to decrease neural drive to inspiratory muscles. The ratio of inspiratory effort to volume displacement should improve, and reductions of inspiratory capacity during exercise should be delayed. These factors are hypothesized to jointly contribute in delaying the occurrence of intolerable symptoms of dyspnea and to improve exercise tolerance in these patients.
We will study physiological mechanisms by which inspiratory muscle training exerts its effects on dyspnea reduction and exercise capacity. In this clinical trial patients will be randomly allocated into either an intervention or a control group. The intervention group will receive a highly intense inspiratory muscle training program that will improve inspiratory muscle function. The control group will receive a sham training that will not result in physiological benefits.
During the 8-week training period patients will have to attend the hospital once weekly for a short visit to perform a training session under supervision. Before the training intervention patients will be assessed twice and then again once after the 8-week program. This means that this trial will involve a total of 11 visits (3 long visits (approximately 4h) for assessments and 8 short visits (approximately 30 minutes) for supervised training sessions) over a period of 2-3 months. Assessments of pulmonary function, inspiratory muscle function, exercise capacity, daily physical activity and symptoms of dyspnea during exercise will be performed. Pulmonary mechanics and inspiratory muscle activation during exercise will also be assessed.
Stable COPD patients with pronounced inspiratory muscle weakness (Pi,max < 70cmH2O or <70% predicted) will be eligible to participate in the study. Exclusion criteria will be diagnosed psychiatric or cognitive disorders, progressive neurological or neuromuscular disorders and severe orthopedic problems having a major impact on exercise capacity.
Patients in both the intervention and the placebo group will follow an eight-week IMT program. They will receive either high intensity IMT (intervention group) or sham IMT (placebo group). Interventions will be presented to patients as strength training (intervention group) or endurance training (placebo group). Measurements of primary and secondary endpoints will be performed before and after 8 weeks of IMT. All tests will be performed by an experienced investigator that will be blinded to group allocation.
Total training load for both groups will be two to three daily sessions of 30 breaths (3-4 minutes per session), on 7 days per week, for 8 weeks. IMT will be performed using a variable flow resistive loading device(POWERbreathe®KH1, HaB International Ltd., Southam, UK).
Differences in primary and secondary outcomes between groups after 8 weeks of IMT will be compared adjusting for baseline differences in an analysis of covariance (ANCOVA).
Dyspnea perception on a 10-point Borg Scale (BORG CR10) at identical ventilation during the constant work rate cycling test after the intervention will be the primary outcome. To detect a difference of one point in the dyspnea perception on a 10-point Borg Scale at identical ventilation during the constant work rate cycling test after the intervention between subjects, assuming a standard deviation of the changes in dyspnea perception between baseline and follow-up measurement of 1 point with a degree of certainty (statistical power) of 80% and a risk for a type I error (a) < 5%, a sample size of 16 patients for each group is needed. These estimates are based on previous work on dyspnea perceptions during exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | Device: Inspiratory Muscle Strength TrainingHigh intensity inspiratory muscle training |
| Inspiratory Muscle Endurance Training | Sham comparator | Device: Inspiratory Muscle Endurance TrainingSham inspiratory muscle training at low intensity |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical Diagnosis of COPD
- Inspiratory Muscle Weakness (Pi,max < 70cmH2O or < 70% predicted)
Key exclusion criteria (1 listed)
- Major cardiovascular, orthopedic, or cognitive impairments limiting exercise capacity more than pulmonary function impairment.
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 |
|---|---|---|
| Inspiratory Muscle Strength TrainingAlso: Electronic Variable Flow Resistive Loading IMT Device, POWERbreathe®KH1, HaB International Ltd., Southam, UKIMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The intervention group (strength IMT) will perform two daily sessions of 30 breaths. Measurements of Pi,max will be performed every week and training loads will be increased continuously to maintain at least 40-50% of the actual Pi,max values. Each week, one training session will be performed under supervision. Training load will be increased during this session. | Device | Inspiratory Muscle Strength Training |
| Inspiratory Muscle Endurance TrainingAlso: Electronic Variable Flow Resistive Loading IMT Device, POWERbreathe®KH1, HaB International Ltd., Southam, UKIMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The sham group (endurance IMT) will perform three daily sessions of 30 breaths and will train at a constant inspiratory load of no more than 10% of their initial Pi,max. Each week, one training session will be performed under supervision. | Device | Inspiratory Muscle Endurance Training |
Primary outcome
Dyspnea (Borg CR-10 scale)
Time frame: Change from Baseline in Borg CR-10 scale at 8 weeks
Numerical value reported for intensity of dyspnea (shortness of breath) ranging from 0 (no symptoms) to 10 (maximal symptoms)
6 secondary outcomes
Maximal inspiratory pressure (Pi,max)
Time frame: Change from Baseline in Pi,max at 8 weeks
Inspiratory Muscle Endurance during a constant load breathing task
Time frame: Change from Baseline in endurance time at 8 weeks
Endurance capacity during a constant load cycling exercise test
Time frame: Change from Baseline in endurance time at 8 weeks
Pulmonary Function
Time frame: Change from Baseline in Pulmonary Function parameters at 8 weeks
Daily Physical Activity
Time frame: Change in daily steps and time in moderate to vigorous daily physical activity from Baseline at 8 weeks
Health related Quality of Life
Time frame: Change from Baseline in health related quality of life at 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 3 Feb 2015.
- Derived from this study: PubMed 40288657Klaps S, Langer D, Gosselink R, Dacha S, Louvaris Z, Jacobs N, Janssens W, Janssens L. The value of extra-diaphragmatic inspiratory muscle surface electromyography during postural control tasks in patients with chronic obstructive pulmonary disease. Respir Med. 2025 Jul;243:108127. doi: 10.1016/j.rmed.2025.108127. Epub 2025 Apr 25.
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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.
Daniel Langer principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Strength Training and Inspiratory Muscle Endurance Training in people with COPD and Severe Systemic Illness-induced Respiratory Muscle Wasting, run by KU Leuven at 1 site in Canada.
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 2 inclusion and 1 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 3 Feb 2015. 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 Canada. 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. 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?
Dyspnea (Borg CR-10 scale) (time frame: Change from Baseline in Borg CR-10 scale at 8 weeks). 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 NCT01900873, 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 3 Feb 2015.