Inspiratory Muscle Training Combined With General Exercise Training in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— IMTGET  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02392715
• Other study ID #: 003/15
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2015
• Last updated: March 27, 2015
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Hôpital Riviera-Chablais, Vaud-Valais
• Contact: Stéphanie Vaudan, BSc
• Phone: +41 24 473 18 99
• Email: stephanie.vaudan[@]hopitalrivierachablais.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

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 Inspiratory muscle training
with Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Riviera-Chablais, Vaud-Valais

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity (six minute walking test)	exercise capacity will be assessed by a six minute walking test	12 weeks	No
Secondary	Quality of Life (St-George's Respiratory questionnaire)	Quality of Life will be assessed by St-George's Respiratory questionnaire	12 weeks	No
Secondary	Maximal inspiratory pressure (MicroRPM by MicroMedical)	Inspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical	12 weeks	No