Inspiratory Muscle Training in Pulmonary Hypertension

Inspiratory Muscle Training in Patients With Pulmonary Hypertension: a Double-blind Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Inspiratory Muscle Training; Inspiratory Muscle Weakness
• Intervention / Treatment: Other: inspiratory muscle training; Other: Placebo "training"

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paul
    • São Paulo, São Paul, Brazil, 04127000
      • SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Limitation to cycling
• Recent syncope or clinical deterioration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental: IMT; inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure	Other: inspiratory muscle training; inspiratory muscle training with 50% of MIP
Placebo Comparator: Placebo: SHAM; inspiratory muscle training (PowerBREATHE) without inspiratory load	Other: Placebo "training"; placebo training with PowerBreathe (without inspiratory load)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise capacity¨- cardiopulmonary exercise testing	TLim (seconds)	week 8
exercise capacity - 6-min walk test	distance (m)	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilatory responses	VE/VCO2	Week 8

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Pulmonary Arterial Hypertension
• Other Study ID Numbers: FUSaoPaulo2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No