Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension

Not Applicable

• Conditions: Inspiratory Muscle Weakness; Chronic Thromboembolic Pulmonary Hypertension; Inspiratory Muscle Training
• Interventions: Other: Placebo "training"; Other: inspiratory muscle training

• Registration Number: NCT03102294
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-07
• Study Start: 2017-09-01
• Primary Completion: 2018-11-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• CTEPH confirmed by RHC and imaging
• NYHA FC II-IV

Exclusion Criteria

• Limitation to cycling
• Recent syncope or clinical deterioration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo: SHAM	Placebo "training"	inspiratory muscle training (PowerBREATHE) without inspiratory load
Experimental: IMT	inspiratory muscle training	inspiratory muscle training (PowerBREATHE) with \~50% of maximum inspiratory pressure

Primary Outcome Measures

Name	Time	Method
exercise capacity - 6-min walk test	week 8	distance (m)
exercise capacity¨- cardiopulmonary exercise testing	week 8	TLim (seconds)

Secondary Outcome Measures

Name	Time	Method
ventilatory responses	Week 8	VE/VCO2
peripheral oxygenation	Week 8	Near-infrared spectroscopy

Trial Locations

Locations (1)

SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício; 🇧🇷 Sao Paulo, São Paul, Brazil