NCT03102294

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

7.3 years

First QC Date

March 22, 2017

Last Update Submit

September 12, 2025

Conditions

Chronic Thromboembolic Pulmonary HypertensionInspiratory Muscle TrainingInspiratory Muscle WeaknessPulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

  • exercise capacity¨- cardiopulmonary exercise testing

    TLim (seconds)

    week 8

  • exercise capacity - 6-min walk test

    distance (m)

    week 8

Secondary Outcomes (1)

  • ventilatory responses

    Week 8

Study Arms (2)

Experimental: IMT

ACTIVE COMPARATOR

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

Other: inspiratory muscle training

Placebo: SHAM

PLACEBO COMPARATOR

inspiratory muscle training (PowerBREATHE) without inspiratory load

Other: Placebo "training"

Interventions

inspiratory muscle trainingOTHER

inspiratory muscle training with 50% of MIP

Experimental: IMT
Placebo "training"OTHER

placebo training with PowerBreathe (without inspiratory load)

Placebo: SHAM

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Limitation to cycling
  • Recent syncope or clinical deterioration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício

São Paulo, São Paul, 04127000, Brazil

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 5, 2017

Study Start

September 1, 2017

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations

BR(1)