Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)

Not Applicable

Completed

• Conditions: COPD; Inspiratory Muscle Weakness
• Interventions: Other: Inspiratory Muscle Training

• Registration Number: NCT01903772
• Lead Sponsor: Schön Klinik Berchtesgadener Land

Brief Summary

The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Primary Completion: 2017-01
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients with COPD
• Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
• Pi,max <60 centimeters of water or <50% of the predicted normal value

Exclusion Criteria

• Major comorbidities preventing successful participation in an 8 week exercise training intervention
• use of non-invasive ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory Muscle Training	Inspiratory Muscle Training	Procedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of \>50% Pi,max
Sham Inspiratory Muscle Training	Inspiratory Muscle Training	Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O)

Primary Outcome Measures

Name	Time	Method
6-Minute walking distance	change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

Secondary Outcome Measures

Name	Time	Method
exercise capacity (constant work rate test)	change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
maximal inspiratory pressure (PImax)	change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
inspiratory muscle endurance capacity	change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program
dyspnea	change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program	measured via Borg-scale at rest, during 6-minute walking distance, during constant work rate test at iso-time, during inspiratory muscle endurance capacity test

Trial Locations

Locations (1)

Schön Klinik Berchtesgadener Land; 🇩🇪 Schönau am Königssee, Bayern, Germany