Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension

August 3, 2017 updated by: Roberta Pulcheri Ramos, Federal University of São Paulo

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paul
      • Sao Paulo, São Paul, Brazil, 04127000
        • SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício
        • Contact:
          • Roberta P Ramos, MD, PhD
        • Sub-Investigator:
          • João V Rolim, PT
        • Principal Investigator:
          • Roberta P Ramos, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Limitation to cycling
  • Recent syncope or clinical deterioration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental: IMT
inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure
Other: inspiratory muscle training
inspiratory muscle training with 50% of MIP
Placebo Comparator: Placebo: SHAM
inspiratory muscle training (PowerBREATHE) without inspiratory load
Other: Placebo "training"
placebo training with PowerBreathe (without inspiratory load)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exercise capacity¨- cardiopulmonary exercise testing
Time Frame: week 8
TLim (seconds)
week 8
exercise capacity - 6-min walk test
Time Frame: week 8
distance (m)
week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventilatory responses
Time Frame: Week 8
VE/VCO2
Week 8
peripheral oxygenation
Time Frame: Week 8
Near-infrared spectroscopy
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

April 30, 2019

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUSaoPaulo2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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