- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045666
Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.
The Impact of Macitentan Therapy and Rehabilitation Program on Peak Oxygen Consumption in Patients With Severe Pulmonary Arterial Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
48 patients, over the age of 18, with PAH classified as WHO III-IV, that are all stable under Macitentan therapy, will be recruited to the study through the PH clinic at Soroka Medical Center. The patients will be randomly divided into intervention and control groups.
The intervention group will exercise in a pulmonary rehabilitation program twice a week, for 12 weeks. The exercise protocol will include circuit training, with 2-3 minutes exercise intervals, including aerobic and strength training, and will be supervised by physiotherapists. The control group will continue to receive their usual Macitentan treatment.
All study participants will undergo tests before the beginning of the intervention program, 6 weeks after it has begun, at the end of the 12 week program, and 3 months after finishing the program. The tests will include a cardio-pulmonary exercise test, 6 minute walk distance measurement, WHO functional class evaluation, levels of Brain natriuretic peptide (BNP), EMPHASIS10 questionnaire (emPHasis-10 questionnaire is a short questionnaire for assessing Health Related Quality of Life in pulmonary arterial hypertension), Short Form-36 (SF-36) quality of life questionnaire and echocardiography.
Once data collection is completed, two way ANOVA repeated measures will be used to assess the changes in outcome measures.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Avital Keren Abriel, MD
- Phone Number: 972 507777618
- Email: avitalab@bgu.ac.il
Study Contact Backup
- Name: Efrat Landau, BPT
- Phone Number: +972545899819
- Email: efratlan@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- PAH patients group 1
- Patients Age > 18 years,
- Patients with WHO III
- Patients on Macitentan treatment who are stable on disease-targeted medication for at least 2 months prior to inclusion.
Exclusion Criteria:
- Patients with other significant comorbidity such as Pulmonary veno-occlusive disease (PVOD) or pulmonary capillary haemangiomatosis, Malignancy, Recent myocardial infarction in the last 2 weeks.
- Patients on other PAH specific medications treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Patients stable on Macitentan therapy will exercise twice a week for 12 weeks, supervised by physiotherapists.
The exercise program includes aerobic and strength exercises, at 2-3 minutes intervals.
|
patients who are stable on Macitentan therapy (received in both groups before enrollment) and will exercise at a pulmonary rehabilitation program twice a week for 12 weeks
Other Names:
|
No Intervention: Control Group
Patients stable on Macitentan therapy that will continue to receive it, without exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardio-pulmonary exercise test- measurements of VO2 , anaerobic threshold, respiratory exchange ratio, O2 pulse, ventilatory reserve, heart rate, End tidal CO2 and O2, work rate, ventilation (VE), VCO2 during exercise test
Time Frame: 0-24 weeks
|
Physiological response to exercise
|
0-24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Echocardiography: dimensions and pressure of left and right ventricles, cardiac output, pulmonary arterial pressure (systolic, diastolic and mean), pulmonary capillary wedge pressure
Time Frame: 0-12 weeks
|
Cardiac function
|
0-12 weeks
|
EMPHASIS10 questionnaire
Time Frame: 0-24 weeks
|
Disease specific quality of life questionnaire
|
0-24 weeks
|
SF-36 questionnaire
Time Frame: 0-24 weeks
|
Quality of life questionnaire
|
0-24 weeks
|
N-terminal prohormone brain natriuretic peptide (NT-proBNP)
Time Frame: 0-12 weeks
|
high levels of NT-proBNP can indicate heart failure
|
0-12 weeks
|
Functional class evaluation
Time Frame: 0-24 weeks
|
Functional class as classified by the world health organization (WHO)
|
0-24 weeks
|
6 minute walk distance
Time Frame: 0-24 weeks
|
Functional capacity assesment by 6 minute walk test
|
0-24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Avital Abriel Keren, Soroka University Medical Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOR-026116-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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