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Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03102294
Recruitment Status : Not yet recruiting
First Posted : April 5, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Roberta Pulcheri Ramos, Federal University of São Paulo

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

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Inspiratory Muscle Training Inspiratory Muscle Weakness Other: inspiratory muscle training Other: Placebo "training" Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training in Patients With Chronic Thromboembolic Pulmonary Hypertension: a Randomized Controlled Trial
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : April 30, 2019


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)




Primary Outcome Measures :
  1. exercise capacity¨- cardiopulmonary exercise testing [ Time Frame: week 8 ]
    TLim (seconds)

  2. exercise capacity - 6-min walk test [ Time Frame: week 8 ]
    distance (m)


Secondary Outcome Measures :
  1. ventilatory responses [ Time Frame: Week 8 ]
    VE/VCO2

  2. peripheral oxygenation [ Time Frame: Week 8 ]
    Near-infrared spectroscopy



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Limitation to cycling
  • Recent syncope or clinical deterioration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102294


Contacts
Contact: Roberta P Ramos, MD, PhD 551150824420 robertapulcheri@gmail.com

Locations
Brazil
SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício Recruiting
Sao Paulo, São Paul, Brazil, 04127000
Contact: Roberta P Ramos, MD, PhD         
Sub-Investigator: João V Rolim, PT         
Principal Investigator: Roberta P Ramos, MD, PhD         
Sponsors and Collaborators
Federal University of São Paulo

Responsible Party: Roberta Pulcheri Ramos, Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03102294     History of Changes
Other Study ID Numbers: FUSaoPaulo2017
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Respiratory Aspiration
Muscle Weakness
Paresis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms