Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.

Not Applicable

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Other: Exercise program

• Registration Number: NCT03045666
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-07
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06
• Study Start: 2017-04-15
• Primary Completion: 2018-02-28
• Study Completion: 2018-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Exercise program	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
SF-36 questionnaire	0-24 weeks	Quality of life questionnaire
Functional class evaluation	0-24 weeks	Functional class as classified by the world health organization (WHO)
EMPHASIS10 questionnaire	0-24 weeks	Disease specific quality of life questionnaire
N-terminal prohormone brain natriuretic peptide (NT-proBNP)	0-12 weeks	high levels of NT-proBNP can indicate heart failure
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
6 minute walk distance	0-24 weeks	Functional capacity assesment by 6 minute walk test