An interventional study of Home-based telerehabilitation program in Pulmonary Arterial Hypertension (PAH), sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment
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.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
This study's planned enrollment of 34 is below the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving an 8-week home-based telerehabilitation program combining three weekly sessions (one live-supervised via videoconference and two independent sessions using pre-recorded modules) focusing on respiratory physiotherapy, inspiratory muscle training, strength, coordination, and aerobic walking.
Other: Home-based telerehabilitation program
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.
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.
Start is estimated for Aug 2026; primary completion for Jul 2029, 34 months later.
Of 60 non-industry interventional studies with no phase under Pulmonary Arterial Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 34 months is below that.
Counting every sponsor, half of 65 studies reached it within 42 months; a quarter within 18 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension →
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud