NCT01397396CompletedPhase 3
Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- KU Leuven
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- 6-Minute Walking Distance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with COPD
- •Eligible to participate in a exercise training intervention of 8 weeks
- •Pi,max <60cmH2O or <50% of the predicted normal value
Exclusion Criteria
- •Major comorbidities preventing successful participation in an 8 week exercise training intervention
Arms & Interventions
Inspiratory Muscle Training
Experimental
Inspiratory Muscle Training
Intervention: Inspiratory Muscle Training (Procedure)
Sham IMT
Placebo Comparator
Sham Inspiratory Muscle Training
Intervention: Inspiratory Muscle Training (Procedure)
Outcomes
Primary Outcomes
6-Minute Walking Distance
Time Frame: Baseline and 8 weeks follow-up
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Langer
Dr Daniel Langer
KU Leuven
Study Sites (1)
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