Inspiratory Muscle Training Combined With General Exercise Training in COPD

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Sham Inspiratory muscle training; Device: Inspiratory muscle training with Threshold by respironics

• Registration Number: NCT02392715
• Lead Sponsor: Hôpital Riviera-Chablais, Vaud-Valais

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Last Update Submitted: 2015-03-27
• Last Update Posted: 2015-03-30
• Study Start: 2015-04
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control cohort	Sham Inspiratory muscle training	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)
Intervention cohort	Inspiratory muscle training with Threshold by respironics	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.

Primary Outcome Measures

Name	Time	Method
Exercise capacity (six minute walking test)	12 weeks	exercise capacity will be assessed by a six minute walking test

Secondary Outcome Measures

Name	Time	Method
Quality of Life (St-George's Respiratory questionnaire)	12 weeks	Quality of Life will be assessed by St-George's Respiratory questionnaire
Maximal inspiratory pressure (MicroRPM by MicroMedical)	12 weeks	Inspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical