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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Inspiratory muscle training with Threshold by respironics; Device: Sham Inspiratory muscle training

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Sham Comparator: 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)	Device: Sham Inspiratory muscle training; with Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hôpital Riviera-Chablais, Vaud-Valais
• Investigators: Principal Investigator: Stéphanie Vaudan, BSc, stephanie.vaudan@hopitalrivierachablais.ch

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; Inspiratory muscle training; chronic obstructive pulmonary disease; General exercise training
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
• Other Study ID Numbers: 003/15