Pulmonary Arterial Hypertension
Conditions
Brief summary
48 patients, over the age of 18, with pulmonary arterial hypertension (PAH) classified as WHO III-IV, that are all stable under Macitentan therapy ( medication for treating PAH patients), will be recruited to the study through the pulmonary hypertension (PH) clinic at Soroka Medical Center. The patients will be randomly divided into an intervention group, which will exercise twice a week for 12 weeks, supervised by physiotherapists, and a control group, which will only receive the medication. Tests will be performed 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.
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.
Interventions
OTHERExercise 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
Sponsors
University of Haifa
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. PAH patients group 1 2. Patients Age \> 18 years, 3. Patients with WHO III 4. Patients on Macitentan treatment who are stable on disease-targeted medication for at least 2 months prior to inclusion.
Exclusion criteria
1. 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. 2. Patients on other PAH specific medications treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 0-24 weeks | Physiological response to exercise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EMPHASIS10 questionnaire | 0-24 weeks | Disease specific quality of life questionnaire |
| SF-36 questionnaire | 0-24 weeks | Quality of life questionnaire |
| Echocardiography: dimensions and pressure of left and right ventricles, cardiac output, pulmonary arterial pressure (systolic, diastolic and mean), pulmonary capillary wedge pressure | 0-12 weeks | Cardiac function |
| Functional class evaluation | 0-24 weeks | Functional class as classified by the world health organization (WHO) |
| 6 minute walk distance | 0-24 weeks | Functional capacity assesment by 6 minute walk test |
| N-terminal prohormone brain natriuretic peptide (NT-proBNP) | 0-12 weeks | high levels of NT-proBNP can indicate heart failure |
Contacts
Primary ContactAvital Keren Abriel, MD
Backup ContactEfrat Landau, BPT
Outcome results
None listed