Telerehabilitation in Pulmonary Arterial Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Home-based telerehabilitation program
Other interventionAn 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.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Telerehabilitation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
6-Minute Walk Distance (6MWD)
Total distance walked in 6 minutes to evaluate functional exercise capacity.
Time frame
Baseline and 8 weeks post-intervention.2
Inflammatory Analytes (Chemokines and Interleukins)
Changes in blood levels of inflammatory biomarkers including chemokines and interleukins.
Time frame
Baseline and 8 weeks post-intervention.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov
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