Inspiratory Muscle Training in Pulmonary Hypertension

Federal University of São Paulo

Status: Completed

Conditions: Inspiratory Muscle Weakness; Inspiratory Muscle Training; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Arterial Hypertension

Treatments: Other: Placebo "training"; Other: inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT03102294

FUSaoPaulo2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Limitation to cycling
• Recent syncope or clinical deterioration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 2 patient groups, including a placebo group

Experimental: IMT

Active Comparator group

Description:

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

Treatment:

Other: inspiratory muscle training

Placebo: SHAM

Placebo Comparator group

Description:

inspiratory muscle training (PowerBREATHE) without inspiratory load

Treatment:

Other: Placebo "training"