Inspiratory Muscle Training in Pulmonary Hypertension

NCT ID: NCT03102294

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2025-01-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Thromboembolic Pulmonary Hypertension Inspiratory Muscle Training Inspiratory Muscle Weakness Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental: IMT

inspiratory muscle training (PowerBREATHE) with \~50% of maximum inspiratory pressure

Group Type ACTIVE_COMPARATOR

inspiratory muscle training

Intervention Type OTHER

inspiratory muscle training with 50% of MIP

Placebo: SHAM

inspiratory muscle training (PowerBREATHE) without inspiratory load

Group Type PLACEBO_COMPARATOR

Placebo "training"

Intervention Type OTHER

placebo training with PowerBreathe (without inspiratory load)

Interventions

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inspiratory muscle training

inspiratory muscle training with 50% of MIP

Intervention Type OTHER

Placebo "training"

placebo training with PowerBreathe (without inspiratory load)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Limitation to cycling
* Recent syncope or clinical deterioration
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Roberta Pulcheri Ramos

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício

São Paulo, São Paul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FUSaoPaulo2017

Identifier Type: -

Identifier Source: org_study_id

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