Inspiratory Muscle Training Combined With General Exercise Training in COPD (IMTGET)

Hôpital Riviera-Chablais, Vaud-Valais

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Inspiratory muscle training with Threshold by respironics; Device: Sham Inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT02392715

003/15

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Intervention cohort

Experimental group

Description:

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.

Treatment:

Device: Inspiratory muscle training with Threshold by respironics

Control cohort

Sham Comparator group

Description:

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)

Treatment:

Device: Sham Inspiratory muscle training