Inspiratory Muscle Training in Patients With Pulmonary Hypertension: a Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- exercise capacity - 6-min walk test
Study Overview
Brief Summary
Inspiratory muscle training for 8 weeks in patients with pulmonary hypertension.
Detailed Description
32 patients with PH will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (~ 75% of maximal work-rate) and step test. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (~ 50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CTEPH confirmed by RHC and imaging
- •NYHA FC II-IV
Exclusion Criteria
- •Limitation to cycling
- •Recent syncope or clinical deterioration
Arms & Interventions
Experimental: IMT
inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure
Intervention: inspiratory muscle training (Other)
Placebo: SHAM
inspiratory muscle training (PowerBREATHE) without inspiratory load
Intervention: Placebo "training" (Other)
Outcomes
Primary Outcomes
exercise capacity - 6-min walk test
Time Frame: week 8
distance (m)
exercise capacity¨- cardiopulmonary exercise testing
Time Frame: week 8
TLim (seconds)
Secondary Outcomes
- ventilatory responses(Week 8)
- ventilatory responses(Week 8)
Investigators
Roberta Pulcheri Ramos
Professor
Federal University of São Paulo