Inspiratory Muscle Training Combined With General Exercise Training in COPD

NCT ID: NCT02392715

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention cohort

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.

Group Type: EXPERIMENTAL

Inspiratory muscle training with Threshold by respironics

Intervention Type: 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.

Control cohort

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)

Group Type: SHAM_COMPARATOR

Sham Inspiratory muscle training

Intervention Type: DEVICE

with Threshold by respironics

15 minutes, 3x/weeks, 36 sessions

Intensity: 5 centimeters of water (cmH20)

Interventions

Inspiratory muscle training with Threshold by respironics

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.

Intervention Type: DEVICE

Sham Inspiratory muscle training

with Threshold by respironics

15 minutes, 3x/weeks, 36 sessions

Intensity: 5 centimeters of water (cmH20)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Riviera-Chablais, Vaud-Valais

OTHER

Sponsor Role: lead

Responsible Party

Stéphanie Vaudan

Stéphanie Vaudan, board-certified respiratory therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stéphanie Vaudan, BSc

Role: PRINCIPAL_INVESTIGATOR

stephanie.vaudan@hopitalrivierachablais.ch

Central Contacts

Stéphanie Vaudan, BSc

Role: CONTACT

stephanie.vaudan@hopitalrivierachablais.ch

+41 24 473 18 99

Nicolas Garin, MD

Role: CONTACT

nicolas.garin@hopitalrivierachablais.ch

+ 41 24 473 80 75

Other Identifiers

003/15

Identifier Type: -

Identifier Source: org_study_id