Back to resultsInspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension
Primary Purpose
Chronic Thromboembolic Pulmonary Hypertension, Inspiratory Muscle Training, Inspiratory Muscle Weakness
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
inspiratory muscle training
Placebo "training"
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria:
- CTEPH confirmed by RHC and imaging
- NYHA FC II-IV
Exclusion Criteria:
- Limitation to cycling
- Recent syncope or clinical deterioration
Sites / Locations
- SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Experimental: IMT
Placebo: SHAM
Arm Description
inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure
inspiratory muscle training (PowerBREATHE) without inspiratory load
Outcomes
Primary Outcome Measures
exercise capacity¨- cardiopulmonary exercise testing
TLim (seconds)
exercise capacity - 6-min walk test
distance (m)
Secondary Outcome Measures
ventilatory responses
VE/VCO2
peripheral oxygenation
Near-infrared spectroscopy
Full Information
NCT ID
NCT03102294
First Posted
March 22, 2017
Last Updated
August 3, 2017
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03102294
Brief Title
Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension
Official Title
Inspiratory Muscle Training in Patients With Chronic Thromboembolic Pulmonary Hypertension: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inspiratory muscle training for 8 weeks in patients with chronic thromboembolic pulmonary hypertension.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension, Inspiratory Muscle Training, Inspiratory Muscle Weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: IMT
Arm Type
Active Comparator
Arm Description
inspiratory muscle training (PowerBREATHE) with ~50% of maximum inspiratory pressure
Arm Title
Placebo: SHAM
Arm Type
Placebo Comparator
Arm Description
inspiratory muscle training (PowerBREATHE) without inspiratory load
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Intervention Description
inspiratory muscle training with 50% of MIP
Intervention Type
Other
Intervention Name(s)
Placebo "training"
Intervention Description
placebo training with PowerBreathe (without inspiratory load)
Primary Outcome Measure Information:
Title
exercise capacity¨- cardiopulmonary exercise testing
Description
TLim (seconds)
Time Frame
week 8
Title
exercise capacity - 6-min walk test
Description
distance (m)
Time Frame
week 8
Secondary Outcome Measure Information:
Title
ventilatory responses
Description
VE/VCO2
Time Frame
Week 8
Title
peripheral oxygenation
Description
Near-infrared spectroscopy
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CTEPH confirmed by RHC and imaging
NYHA FC II-IV
Exclusion Criteria:
Limitation to cycling
Recent syncope or clinical deterioration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta P Ramos, MD, PhD
Phone
551150824420
Email
robertapulcheri@gmail.com
Facility Information:
Facility Name
SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício
City
Sao Paulo
State/Province
São Paul
ZIP/Postal Code
04127000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta P Ramos, MD, PhD
First Name & Middle Initial & Last Name & Degree
João V Rolim, PT
First Name & Middle Initial & Last Name & Degree
Roberta P Ramos, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension
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