Inspiratory Muscle Training Combined With General Exercise Training in COPD

Study Overview
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Brief Summary
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Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary benefit in the rehabilitation of COPD patients is however uncertain.

Detailed Description
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Prospective, parallel-group, randomized controlled trial 80 COPD patients will be randomized into two groups. One group will receive general exercise training combined with inspiratory muscle training, 3 times a week, for a total of 36 sessions. The other group will receive general exercise training combined with shame inspiratory muscle training, 3 times a week, for a total of 36 sessions. We will assess the difference of improvement in exercise capacity between the 2 groups with the 6 minute walking test. We will also assess the difference of improvement in quality of life with St-George's respiratory questionnaire. Finally the difference of improvement in maximal inspiratory pressure will be determined. Patients and investigators assessing the outcomes will be blinded to group allocation. Written informed consent will be obtained from each subject. The data will be treated anonymously.

Official Title
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Inspiratory Muscle Training Combined With General Exercise Training, Compared to General Exercise Training Alone in Patients With COPD: Randomized Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Inspiratory muscle training with Threshold by respironics
* Device: Sham Inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD demonstrated by spirometry using Gold Criteria Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey Patient with maximal inspiratory pressure < 60 cmH20 Patient older than 40 years Exclusion Criteria: Orthopaedic or neurological troubles that could slant the 6 minute walking test

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention cohort<br>36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' inspiratory muscle training with Threshold by Respironics Inspiratory muscle training intensity: 15% of maximal inspiratory pressure (PiMax) during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax. | Device: Inspiratory muscle training with Threshold by respironics<br>* Inspiratory muscle training 15 minutes, 3x/weeks, 36 sessions Intensity: 15% of PiMax during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.<br>|
| Sham Comparator: Control cohort<br>36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' sham inspiratory muscle training with Threshold by Respironics Sham inspiratory muscle training intensity : 5 centimeters of water (cmH20) | Device: Sham Inspiratory muscle training<br>* with Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity (six minute walking test) | exercise capacity will be assessed by a six minute walking test | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (St-George's Respiratory questionnaire) | Quality of Life will be assessed by St-George's Respiratory questionnaire | 12 weeks | 
| Maximal inspiratory pressure (MicroRPM by MicroMedical) | Inspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inspiratory muscle training, General exercise training, pulmonary rehabilitation, chronic obstructive pulmonary disease