PAHEPRQoL-PAHNCT06973382
Effects of Pulmonary Rehabilitation on Quality of Life and Health in Pulmonary Arterial Hypertension Patients
A study testing Comprehensive Pulmonary Rehabilitation Program and Standard Pulmonary Rehabilitation in people with PAH and CTEPH, run by Beijing Chao Yang Hospital.
Trial summary
Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Comprehensive Pulmonary Rehabilitation Program and Standard Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 31 Oct 2027
- 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
- Right heart catheterization-confirmed pulmonary hypertension
- Meets 2022 ESC/ERS Guidelines diagnostic criteria for:
- Group 1 (PAH) or
- Group 4 (CTEPH/other pulmonary artery obstructions)
- Stabilized Treatment Status:
- Group 1 (PAH): Received ≥3 months of targeted drug therapy
Show all 11Show fewer
- Group 4 (CTEPH): Completed ≥6 sessions of BPA or reached therapeutic endpoint
- Functional Capacity:
- WHO Functional Class I-III
- Age: ≥18 years
- Consent: Willing to provide written informed consent -
Who cannot join
- Unable to perform pulmonary rehabilitation exercises due to disability or congenital malformations
- Cardiopulmonary Testing Contraindications:
- Medically unfit to complete CPET (cardiopulmonary exercise testing) after evaluation
- Poor Compliance:
- History of non-adherence making protocol completion unlikely
- Life Expectancy:
- Prognosis ≤1 year
- -
About this study
Official title: Intervention Study of a Comprehensive Pulmonary Rehabilitation Program on Quality of Life and Prognosis in Patients With Pulmonary Arterial Hypertension
Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC/ERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.
- Being tested
- Comprehensive Pulmonary Rehabilitation Program, Standard Pulmonary Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Pulmonary Rehabilitation ProgramBehavioural
Combined Aerobic + Resistance Training Program Mode: Cycle ergometry (stationary bicycle) Frequency: 3-5 sessions per week Program Duration: 12 weeks
Session Structure:
- 5-minute warm-up
- Continuous or interval training (15-30 minutes)
- 5-minute cool-downesistance Exercise Component
Mode: Dumbbell exercises + cycle ergometry
Frequency: 3 sessions per week
Program Duration: 12 weeks
Session Structure:
- 5-minute warm-up
- Training session (10-20 minutes)
- 5-minute cool-down
Standard Pulmonary RehabilitationBehavioural
xercise Components:
Aerobic Exercise
Mode: Walking or jogging
Resistance Exercise
Mode: Elastic bands or dumbbells
Training Parameters:
Session Duration: ≥35 minutes (combined aerobic + resistance)
Frequency: 3-5 sessions per week
Program Duration: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Pulmonary Rehabilitation Program | Experimental | Not described Receives: Behavioral: Comprehensive Pulmonary Rehabilitation Program |
| Standard Pulmonary Rehabilitation | Active comparator | Not described Receives: Behavioral: Standard Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWD
Measured: 12week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 May 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAHStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973382
- Sponsor's protocol ID
- 2025-KE-62-1
- Acronym
- EPRQoL-PAH
- Status last verified
- Feb 2025
- First submitted
- 14 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study of a Comprehensive Pulmonary Rehabilitation Program on Quality of Life and Prognosis in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06973382
- Acronym / sponsor ID
- EPRQoL-PAH / 2025-KE-62-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 May 2025 (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.
Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC/ERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Pulmonary Rehabilitation Program | Experimental | Behavioral: Comprehensive Pulmonary Rehabilitation Program |
| Standard Pulmonary Rehabilitation | Active comparator | Behavioral: Standard Pulmonary Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Right heart catheterization-confirmed pulmonary hypertension
- Group 1 (PAH) or
- Group 4 (CTEPH/other pulmonary artery obstructions)
- Group 1 (PAH): Received ≥3 months of targeted drug therapy
- Group 4 (CTEPH): Completed ≥6 sessions of BPA or reached therapeutic endpoint
Key exclusion criteria (8 listed)
- Unable to perform pulmonary rehabilitation exercises due to disability or congenital malformations
- Medically unfit to complete CPET (cardiopulmonary exercise testing) after evaluation
- History of non-adherence making protocol completion unlikely
- Prognosis ≤1 year
- -
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 |
|---|---|---|
| Comprehensive Pulmonary Rehabilitation ProgramCombined Aerobic + Resistance Training Program Mode: Cycle ergometry (stationary bicycle) Frequency: 3-5 sessions per week Program Duration: 12 weeks Session Structure: * 5-minute warm-up * Continuous or interval training (15-30 minutes) * 5-minute cool-downesistance Exercise Component Mode: Dumbbell exercises + cycle ergometry Frequency: 3 sessions per week Program Duration: 12 weeks Session Structure: * 5-minute warm-up * Training session (10-20 minutes) * 5-minute cool-down | Behavioural | Comprehensive Pulmonary Rehabilitation Program |
| Standard Pulmonary Rehabilitationxercise Components: Aerobic Exercise Mode: Walking or jogging Resistance Exercise Mode: Elastic bands or dumbbells Training Parameters: Session Duration: ≥35 minutes (combined aerobic + resistance) Frequency: 3-5 sessions per week Program Duration: 12 weeks | Behavioural | Standard Pulmonary Rehabilitation |
Primary outcome
6MWD
Time frame: 12week
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 15 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Pulmonary Rehabilitation Program and Standard Pulmonary Rehabilitation in people with PAH and CTEPH, run by Beijing Chao Yang Hospital.
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 11 inclusion and 8 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWD (time frame: 12week). 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 15 May 2025.