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CompletedNCT03102294Updated Sep 18, 2025

Inspiratory Muscle Training in Pulmonary Hypertension

An interventional study of inspiratory muscle training and Placebo "training" in Chronic Thromboembolic Pulmonary Hypertension, Inspiratory Muscle Training and Inspiratory Muscle Weakness, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Thromboembolic Pulmonary Hypertension
  • Inspiratory Muscle Training
  • Inspiratory Muscle Weakness
  • Pulmonary Arterial Hypertension
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 32 is below the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Limitation to cycling
  • Recent syncope or clinical deterioration
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    Experimental: IMT

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

    Other: inspiratory muscle training

  • Placebo comparator
    Placebo: SHAM

    inspiratory muscle training (PowerBREATHE) without inspiratory load

    Other: Placebo "training"

Interventions

  • Otherinspiratory muscle training

    inspiratory muscle training with 50% of MIP

  • OtherPlacebo "training"

    placebo training with PowerBreathe (without inspiratory load)

06

What researchers measure

Primary outcomes

  1. exercise capacity¨- cardiopulmonary exercise testing

    TLim (seconds)

    Time frame: week 8

  2. exercise capacity - 6-min walk test

    distance (m)

    Time frame: week 8

Secondary outcomes

  1. ventilatory responses

    VE/VCO2

    Time frame: Week 8

07

Study locations

1 site
  • SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício
    São Paulo, São Paul 04127000, Brazil
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03102294
Lead sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Roberta Pulcheri Ramos (Professor, Federal University of São Paulo) — Principal investigator
First posted
Apr 5, 2017
Start date
Sep 1, 2017
Primary completion
Dec 30, 2024
Completion
Jan 30, 2025
Last update
Sep 18, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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