Clinical Trial: Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Inspiratory Muscle Training in Patients With Chronic Thromboembolic Pulmonary Hypertension: a Randomized Controlled Trial

Brief Summary: Inspiratory muscle training for 8 weeks in patients with chronic thromboembolic pulmonary hypertension.

Detailed Summary: 32 patients with CTEPH (confirmed by right cardiac catheterization and imaging) will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) evaluation of peripheral muscle strength by isokinetic dynamometry; 4) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (~ 75% of maximal work-rate) with non-invasive evaluation of central hemodynamics and peripheral muscle oxygenation. 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.
Sponsor: Federal University of São Paulo

Current Primary Outcome:

• exercise capacity¨- cardiopulmonary exercise testing [ Time Frame: week 8 ]
  TLim (seconds)
• exercise capacity - 6-min walk test [ Time Frame: week 8 ]
  distance (m)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• ventilatory responses [ Time Frame: Week 8 ]
  VE/VCO2
• peripheral oxygenation [ Time Frame: Week 8 ]
  Near-infrared spectroscopy

Original Secondary Outcome: Same as current

Information By: Federal University of São Paulo

Dates:
Date Received: March 22, 2017
Date Started: April 15, 2017
Date Completion: April 30, 2019
Last Updated: March 30, 2017
Last Verified: March 2017