Telerehabilitation in Pulmonary Arterial Hypertension

Efficacy, Safety and Effect on the Inflammatory State of a Telerehabilitation Program in Patients With Hypertension Pulmonary Artery

Context: Pulmonary arterial hypertension (PAH) causes severe exercise intolerance and reduced quality of life, while access to supervised rehabilitation remains limited.

Objective: Evaluate the safety, feasibility, and clinical effects of an 8-week structured home-based telerehabilitation program in stable PAH patients. Methods: A multicenter, prospective, single-arm study including 34 adults with Group 1 PAH (WHO functional class II-III) performing three weekly exercise sessions via a digital platform.

Outcomes: The primary endpoint is peak oxygen consumption (VO₂peak) via cardiopulmonary exercise testing, alongside 6-minute walk distance, quality of life questionnaires, inflammatory biomarkers, and safety tracking.

Study Design & Objectives: This is a multicenter, prospective, single-arm interventional study evaluating the safety, feasibility, and clinical effects of an 8-week multimodal telerehabilitation program in patients with stable Group 1 pulmonary arterial hypertension (PAH).

Participant Population: The study will recruit adults with confirmed Group 1 PAH (idiopathic, heritable, connective tissue disease-associated, or repaired congenital heart disease-associated) in World Health Organization (WHO) functional class II-III who are clinically stable on optimized medical therapy.

Intervention Protocol: Participants will complete an 8-week home-based telerehabilitation program via a dedicated mobile application, consisting of three 60-minute sessions per week combining respiratory physiotherapy, inspiratory muscle training, strength and functional exercises, coordination, aerobic walking, and flexibility exercises. One weekly session will be supervised live via videoconference by an experienced physiotherapist, while the remaining two sessions will use pre-recorded modules.

Assessments & Outcomes: Evaluations occur at baseline, immediately post-intervention, and at a 6-month follow-up. The primary endpoint is peak oxygen consumption ($VO_2peak$) measured via cardiopulmonary exercise testing (CPET), with secondary outcomes including 6-minute walk distance, ventilatory efficiency, health-related quality of life (SF-36 and CAMPHOR questionnaires), physical activity levels, inflammatory and myocardial stress biomarkers, and safety/adverse events.

Inclusion Criteria:

• Confirmed diagnosis of stable pulmonary arterial hypertension (PAH).
• Age 18 years or older.
• Ability to use a smartphone or mobile application for the telerehabilitation program.
• Signed informed consent.

Exclusion Criteria:

• Acute cardiorespiratory instability or medical contraindication to physical exercise.
• Cognitive impairment or psychiatric disorders preventing comprehension or use of the telerehabilitation program.
• Simultaneous participation in another interventional clinical trial.