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Inspiratory Muscle Training in Pulmonary Hypertension

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03102294
Enrollment
32
Registered
2017-04-05
Start date
2017-09-01
Completion date
2025-01-30
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

OTHERinspiratory muscle training

inspiratory muscle training with 50% of MIP

placebo training with PowerBreathe (without inspiratory load)

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Limitation to cycling * Recent syncope or clinical deterioration

Design outcomes

Primary

MeasureTime frameDescription
exercise capacity¨- cardiopulmonary exercise testingweek 8TLim (seconds)
exercise capacity - 6-min walk testweek 8distance (m)

Secondary

MeasureTime frameDescription
ventilatory responsesWeek 8VE/VCO2

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026