Impact of Rehabilitation Program on PAH Patients Treated With Macitentan.

NCT03045666 | Unknown

• 1 other identifier: SOR-026116-CTIL
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

  Physiological response to exercise

  0-24 weeks

Secondary Outcomes (6)

• 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

• EMPHASIS10 questionnaire

  0-24 weeks

• SF-36 questionnaire

  0-24 weeks

• N-terminal prohormone brain natriuretic peptide (NT-proBNP)

  0-12 weeks

• Functional class evaluation

  0-24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Patients stable on Macitentan therapy that will continue to receive it, without exercise.

Interventions

Exercise program OTHER

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

Also known as: Rehabilitation program

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAH patients group 1
• Patients Age \> 18 years,
• Patients with WHO III

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soroka University Medical Center: lead
• University of Haifa: collaborator

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Resistance Training; Rehabilitation

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Avital Abriel Keren

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Avital Keren Abriel, MD

CONTACT

507777618; avitalab@bgu.ac.il

Efrat Landau, BPT

CONTACT

+972545899819; efratlan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 7, 2017
• Study Start: April 15, 2017
• Primary Completion: February 28, 2018
• Study Completion: May 1, 2018
• Last Updated: April 6, 2017

Record last verified: 2017-01