Pulmonary Arterial Hypertension (PAH)
Conditions
Keywords
Telerehabilitation, Pulmonary rehabilitation, Pulmonary arterial hypertension, Cardiopulmonary exercise testing, Ventilatory efficiency
Brief summary
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.
Detailed description
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.
Interventions
OTHERHome-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.
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A multicenter, prospective, single-arm interventional study with a pre-post design, evaluating an 8-week home-based telerehabilitation program in patients with stable pulmonary arterial hypertension (PAH).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity determined by peak O2 consumption (VO2peak) | Comparison between baseline and the value obtained after 8 weeks of intervention. | Evaluation of the intervention's efficacy through the increase in peak oxygen consumption during cardiopulmonary exercise testing (CPET/PECP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Distance (6MWD) | Baseline and 8 weeks post-intervention. | Total distance walked in 6 minutes to evaluate functional exercise capacity. |
| Inflammatory Analytes (Chemokines and Interleukins) | Baseline and 8 weeks post-intervention. | Changes in blood levels of inflammatory biomarkers including chemokines and interleukins. |
| Safety and Adverse Events During Exercise | Throughout the 8-week intervention period. | Incidence of relevant clinical events during therapeutic exercise (such as chest pain or syncope). |
| Maximal Minute Ventilation During Cardiopulmonary Exercise Testing (CPET) | Baseline and 8 weeks post-intervention. | Assessment of maximal minute ventilation achieved during CPET, expressed in liters per minute (L/min). |
| Oxygen Desaturation During Cardiopulmonary Exercise Testing (CPET) | Baseline and 8 weeks post-intervention. | Assessment of oxygen desaturation during CPET, expressed as percentage of peripheral oxygen saturation (SpO₂, %). |
| Oxygen Pulse During Cardiopulmonary Exercise Testing (CPET) | Baseline and 8 weeks post-intervention. | Assessment of oxygen pulse (O₂ pulse) during CPET, expressed in milliliters of oxygen per heartbeat (mL/beat). |
| EqCO₂ at the Anaerobic Threshold During Cardiopulmonary Exercise Testing (CPET) | Baseline and 8 weeks post-intervention. | Assessment of the ventilatory equivalent for carbon dioxide (EqCO₂) at the anaerobic threshold during CPET. EqCO₂ is expressed as a dimensionless ratio. |
| Minimum Oxygen Saturation During Cardiopulmonary Exercise Testing (CPET) | Baseline and 8 weeks post-intervention. | Minimum peripheral oxygen saturation (SpO₂) recorded during CPET, expressed as a percentage (%). |
| Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Symptoms Score | Baseline and 8 weeks post-intervention. | 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. |
| Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Activities Score | Baseline and 8 weeks post-intervention. | 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. |
| Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Quality of Life Score | Baseline and 8 weeks post-intervention. | 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. |
Countries
Spain
Contacts
CONTACTFIMABIS
Outcome results
None listed