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NCT03102294 Clinical Trial

Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:
Inspiratory Muscle Training in Patients With Chronic Thromboembolic Pulmonary Hypertension: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03102294
Other study ID # FUSaoPaulo2017
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 22, 2017
Last updated August 3, 2017
Start date September 1, 2017
Est. completion date April 30, 2019

Study information
Verified date August 2017
Source Federal University of São Paulo
Contact Roberta P Ramos, MD, PhD
Phone 551150824420
Email robertapulcheri@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

32 patients with CTEPH (confirmed by right cardiac catheterization and imaging) will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) evaluation of peripheral muscle strength by isokinetic dynamometry; 4) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (~ 75% of maximal work-rate) with non-invasive evaluation of central hemodynamics and peripheral muscle oxygenation. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 32
Est. completion date April 30, 2019
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- CTEPH confirmed by RHC and imaging

- NYHA FC II-IV

Exclusion Criteria:

- Limitation to cycling

- Recent syncope or clinical deterioration

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• inspiratory muscle training
inspiratory muscle training with 50% of MIP
• Placebo "training"
placebo training with PowerBreathe (without inspiratory load)

Locations
Country Name City State
Brazil SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício Sao Paulo São Paul

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary exercise capacity¨- cardiopulmonary exercise testing TLim (seconds) week 8
Primary exercise capacity - 6-min walk test distance (m) week 8
Secondary ventilatory responses VE/VCO2 Week 8
Secondary peripheral oxygenation Near-infrared spectroscopy Week 8
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