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OpenTrials
Completed

NCT Number: NCT03102294

Inspiratory Muscle Training in Pulmonary Hypertension

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

Completed

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension Hypertension, Pulmonary Inspiratory Muscle Training Inspiratory Muscle Weakness Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício

São Paulo, São Paul, 04127000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Limitation to cycling
  • Recent syncope or clinical deterioration

Treatment and study plan

Inspiratory Muscle Training

Other

inspiratory muscle training with 50% of MIP

Placebo "training"

Other

placebo training with PowerBreathe (without inspiratory load)

Primary outcomes

  1. exercise capacity¨- cardiopulmonary exercise testing

    Time frame: week 8

    TLim (seconds)

  2. exercise capacity - 6-min walk test

    Time frame: week 8

    distance (m)

Secondary outcomes

  1. ventilatory responses

    Time frame: Week 8

    VE/VCO2

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Apr 5, 2017
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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