Pulmonary Arterial Hypertension (PAH)TRHP-001NCT07799675
Telerehabilitation in Pulmonary Arterial Hypertension
A study testing Home-based telerehabilitation program in people with Pulmonary Arterial Hypertension (PAH), run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- Home-based telerehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 30 Aug 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
FIMABIS
Málaga, Málaga, 29007
FIMABIS, +34 951030435, investigacion.independiente@ibima.eu
Victor Manuel l Becerra Muñoz., Doctor
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- Home-based telerehabilitation program
- Keywords
- Telerehabilitation, Pulmonary rehabilitation, Pulmonary arterial hypertension, Cardiopulmonary exercise testing, Ventilatory efficiency
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based telerehabilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | 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. Receives: Other: Home-based telerehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Comparison between baseline and the value obtained after 8 weeks of intervention.
Secondary outcomes (11)
6-Minute Walk Distance (6MWD)
Total distance walked in 6 minutes to evaluate functional exercise capacity.
Measured: Baseline and 8 weeks post-intervention.
Inflammatory Analytes (Chemokines and Interleukins)
Changes in blood levels of inflammatory biomarkers including chemokines and interleukins.
Measured: 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).
Measured: 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).
Measured: 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, %).
Measured: 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).
Measured: 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.
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799675
- Sponsor's protocol ID
- SICEIA-2026-002596
- Acronym
- TRHP-001
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Effect on the Inflammatory State of a Telerehabilitation Program in Patients With Hypertension Pulmonary Artery
- ClinicalTrials.gov ID
- NCT07799675
- Acronym / sponsor ID
- TRHP-001 / SICEIA-2026-002596
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Telerehabilitation, Pulmonary rehabilitation, Pulmonary arterial hypertension, Cardiopulmonary exercise testing, Ventilatory efficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: Home-based telerehabilitation programParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based telerehabilitation programAn 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. | Other | Telerehabilitation Group |
Primary outcome
Functional capacity determined by peak O2 consumption (VO2peak)
Time frame: 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).
11 secondary outcomes
6-Minute Walk Distance (6MWD)
Time frame: Baseline and 8 weeks post-intervention.
Inflammatory Analytes (Chemokines and Interleukins)
Time frame: Baseline and 8 weeks post-intervention.
Safety and Adverse Events During Exercise
Time frame: Throughout the 8-week intervention period.
Maximal Minute Ventilation During Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline and 8 weeks post-intervention.
Oxygen Desaturation During Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline and 8 weeks post-intervention.
Oxygen Pulse During Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline and 8 weeks post-intervention.
EqCO₂ at the Anaerobic Threshold During Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline and 8 weeks post-intervention.
Minimum Oxygen Saturation During Cardiopulmonary Exercise Testing (CPET)
Time frame: Baseline and 8 weeks post-intervention.
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Symptoms Score
Time frame: Baseline and 8 weeks post-intervention.
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Activities Score
Time frame: Baseline and 8 weeks post-intervention.
Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) - Quality of Life Score
Time frame: Baseline and 8 weeks post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Related trials for Pulmonary Arterial Hypertension (PAH)
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
RecruitingPhase 4
Sotatercept in Pulmonary Arterial Hypertension
Pulmonary Artery Hypertension
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based telerehabilitation program in people with Pulmonary Arterial Hypertension (PAH), run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FIMABIS (+34 951030435 ext. +34, investigacion.independiente@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity determined by peak O2 consumption (VO2peak) (time frame: Comparison between baseline and the value obtained after 8 weeks of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.