Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention cohort | Experimental | 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. |
|
| Control cohort | Sham Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle training with Threshold by respironics | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity (six minute walking test) | exercise capacity will be assessed by a six minute walking test | 12 weeks |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphanie Vaudan, BSc | Contact | +41 24 473 18 99 | stephanie.vaudan@hopitalrivierachablais.ch | |
| Nicolas Garin, MD | Contact | + 41 24 473 80 75 | nicolas.garin@hopitalrivierachablais.ch |
| Name | Affiliation | Role |
|---|---|---|
| Stéphanie Vaudan, BSc | stephanie.vaudan@hopitalrivierachablais.ch | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham Inspiratory muscle training | Device | with Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20) |
|
Inspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical
| 12 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |