- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03102294
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
- Name: Roberta P Ramos, MD, PhD
- Phone Number: 551150824420
- Email: robertapulcheri@gmail.com
Study Locations
-
-
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
|
inspiratory muscle training with 50% of MIP
|
Placebo Comparator: Placebo: SHAM
inspiratory muscle training (PowerBREATHE) without inspiratory load
|
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
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
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Hypertension
- Respiratory Aspiration
- Muscle Weakness
- Hypertension, Pulmonary
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.
Clinical Trials on Chronic Thromboembolic Pulmonary Hypertension
-
University of California, San FranciscoRecruitingChronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic DiseaseUnited States
-
University of ZurichCompletedPulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension | Chronic Cardiorespiratory DiseaseSwitzerland
-
SciPharm SàRLCompletedNon-operable Chronic Thromboembolic Pulmonary HypertensionAustria, Poland, Czechia, Germany
-
ActelionEPS Corporation; Imepro Inc.; General Laboratory, BML, Inc.; Mitsubishi Logistics...TerminatedChronic Thromboembolic Pulmonary Hypertension (CTEPH)Japan
-
University of California, San DiegoE Squared Trials and Registries, Inc.CompletedPulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension (CTEPH)United States
-
Assistance Publique - Hôpitaux de ParisMerck Sharp & Dohme LLCRecruitingPulmonary Embolism | Chronic Thromboembolic Pulmonary Hypertension (CTEPH)France
-
University of ZurichCompletedPulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionSwitzerland
-
University of SheffieldSheffield Teaching Hospitals NHS Foundation TrustUnknownChronic Thromboembolic Pulmonary Hypertension
-
University of AarhusHospitalsenheden VestUnknownChronic Thromboembolic Pulmonary Disease
-
China-Japan Friendship HospitalRecruitingChronic Thromboembolic Pulmonary HypertensionChina
Clinical Trials on inspiratory muscle training
-
Elisabethinen HospitalUnknownStem Cell Transplantation | Inspiratory Muscle Training | Respiratory Muscle TrainingAustria
-
Dokuz Eylul UniversityDokuz Eylül University, Scientific Research Projects Coordination UnitCompleted
-
University of British ColumbiaNatural Sciences and Engineering Research Council, CanadaCompletedRespiratory Muscles | Breathing ExercisesCanada
-
King Saud UniversityCompleted
-
Universidad Complutense de MadridColegio Profesional de Fisioterapeutas de la Comunidad de Madrid, Madrid,...CompletedQuality of Life | Covid19 | Respiratory Muscle Training | Respiratory Function Test | Psychosocial FactorSpain
-
Universidade do PortoUnknownMuscle Weakness | Dyspnea | Reactive Airways Dysfunction Syndrome (Disorder)Portugal
-
Gazi UniversityCompletedAllogeneic Hematopoietic Stem Cell Transplantation
-
Gazi UniversityCompleted
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto AlegreUnknownChronic Kidney Disease