Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Supportive Care
|Official Title:||The Impact of Macitentan Therapy and Rehabilitation Program on Peak Oxygen Consumption in Patients With Severe Pulmonary Arterial Hypertension|
- 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
- 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
- EMPHASIS10 questionnaire [ Time Frame: 0-24 weeks ]Disease specific quality of life questionnaire
- SF-36 questionnaire [ Time Frame: 0-24 weeks ]Quality of life questionnaire
- N-terminal prohormone brain natriuretic peptide (NT-proBNP) [ Time Frame: 0-12 weeks ]high levels of NT-proBNP can indicate heart failure
- Functional class evaluation [ Time Frame: 0-24 weeks ]Functional class as classified by the world health organization (WHO)
- 6 minute walk distance [ Time Frame: 0-24 weeks ]Functional capacity assesment by 6 minute walk test
|Anticipated Study Start Date:||April 15, 2017|
|Estimated Study Completion Date:||May 1, 2018|
|Estimated Primary Completion Date:||February 28, 2018 (Final data collection date for primary outcome measure)|
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.
Other: Exercise program
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 Name: Rehabilitation program
No Intervention: Control Group
Patients stable on Macitentan therapy that will continue to receive it, without exercise.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03045666
|Contact: Avital Keren Abriel, MD||507777618 ext firstname.lastname@example.org|
|Contact: Efrat Landau, BPTemail@example.com|
|Principal Investigator:||Avital Abriel Keren||Soroka University Medical Center|