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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
An 8-week home-based telerehabilitation program delivered via a mobile application, consisting of three weekly 60-minute sessions combining respiratory physiotherapy, inspiratory muscle training, strength exercises, coordination, aerobic walking, and stretching. One session is live-supervised via videoconference and two are completed independently using pre-recorded modules.
FIMABIS
Málaga, Málaga, Spain
Functional capacity determined by peak O2 consumption (VO2peak)
Evaluation of the intervention's efficacy through the increase in peak oxygen consumption during cardiopulmonary exercise testing (CPET/PECP).
Time frame: Comparison between baseline and the value obtained after 8 weeks of intervention.
6-Minute Walk Distance (6MWD)
Total distance walked in 6 minutes to evaluate functional exercise capacity.
Time frame: Baseline and 8 weeks post-intervention.
Inflammatory Analytes (Chemokines and Interleukins)
Changes in blood levels of inflammatory biomarkers including chemokines and interleukins.
Time frame: Baseline and 8 weeks post-intervention.
Safety and Adverse Events During Exercise
Incidence of relevant clinical events during therapeutic exercise (such as chest pain or syncope).
Time frame: Throughout the 8-week intervention period.
Maximal Minute Ventilation During Cardiopulmonary Exercise Testing (CPET)
Assessment of maximal minute ventilation achieved during CPET, expressed in liters per minute (L/min).
Time frame: Baseline and 8 weeks post-intervention.
Oxygen Desaturation During Cardiopulmonary Exercise Testing (CPET)
Assessment of oxygen desaturation during CPET, expressed as percentage of peripheral oxygen saturation (SpO₂, %).
Time frame: Baseline and 8 weeks post-intervention.
Oxygen Pulse During Cardiopulmonary Exercise Testing (CPET)
Assessment of oxygen pulse (O₂ pulse) during CPET, expressed in milliliters of oxygen per heartbeat (mL/beat).
Time frame: Baseline and 8 weeks post-intervention.
EqCO₂ at the Anaerobic Threshold During Cardiopulmonary Exercise Testing (CPET)
Assessment of the ventilatory equivalent for carbon dioxide (EqCO₂) at the anaerobic threshold during CPET. EqCO₂ is expressed as a dimensionless ratio.
Time frame: Baseline and 8 weeks post-intervention.
Minimum Oxygen Saturation During Cardiopulmonary Exercise Testing (CPET)
Minimum peripheral oxygen saturation (SpO₂) recorded during CPET, expressed as a percentage (%).
Time frame: Baseline and 8 weeks post-intervention.
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Symptoms Score
Assessment of symptoms using the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Symptoms scale. Scores range from 0 to 25, with higher scores indicating more severe symptoms.
Time frame: Baseline and 8 weeks post-intervention.
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Activities Score
Assessment of activity limitations using the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Activities scale. Scores range from 0 to 30, with higher scores indicating greater activity limitation.
Time frame: Baseline and 8 weeks post-intervention.
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Quality of Life Score
Assessment of quality of life using the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Quality of Life scale. Scores range from 0 to 25, with higher scores indicating poorer quality of life.
Time frame: Baseline and 8 weeks post-intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.