Pulmonary HypertensionNCT07149935
Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients
A study testing Rehabilitation Training in people with Pulmonary Hypertension, run by RenJi Hospital at 1 site in China.
Trial summary
This multicenter, open label, double-arm study aims at investigating the the continuous effect of long-Term rehabilitation training on clinical improvement(ITTCI) and cardiopulmonary function in pulmonary arterial hypertension patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Rehabilitation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who suffered from pre-capillary PAH (mPAP ≥ 20 mmHg, PVR > 2 Woods unit, PAWP ≤ 15 mmHg) confirmed by right heart catheterisation.
- Patients who are in the status of WHO-FC I-III.
- Patients between 18 and 75 years old
- Female subjects are not pregnant.
- Patients are treated with PAH-targeted drugs and are in a stable state and there is no progress of disease).
- Patients have not received exercise rehabilitation training within six months.
Who cannot join
- Patients with the following diseases or symptoms:
- Pulmonary vascular occlusive disease
- Respiratory diseases
- Ischaemic heart disease, complex congenital heart disease (e.g., tetralogy of Fallot, etc.), cardiomyopathy, valvular disease
- Active liver disease
- Severe kidney disease
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- Motor disorders (e.g. lower limb fracture, ataxia, etc.)
- Malignant tumour diseases
- Physical disability
- Hb ≤ 80g / L
- Systolic blood pressure ≤85mmHg
- History of syncope within 3 months
- History of supraventricular or ventricular arrhythmia at rest within 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 210007
Jun Tong, postgra, 19121913396, tj0129@sjtu.edu.cn
About this study
Official title: Continuous Effect Of Long-Term Rehabilitation Training On Clinical Improvement(TTCI) And Cardiopulmonary Function In Pulmonary Arterial Hypertension Patients- A Multicenter-randomisation Study
This multicenter, open label, double-arm study aims at investigating the the continuous effect of long-Term rehabilitation training on clinical improvement(ITTCI) and cardiopulmonary function in pulmonary arterial hypertension patients
Read the detailed description
Pulmonary Arterial Hypertension (PAH) is a disease caused by various reasons leading to pulmonary vascular remodelling and then results in a progressive increase in pulmonary vascular resistance and right heart failure. PAH progresses rapidly,with a poor prognosis. Targeted drugs has brought about an improvement in the quality of life of patients with PAH. However, in most cases, patients' clinical symptoms will be gradually worsen with exercise capacity gradually declining. The prognosis of PAH remains bleak. Although exercise was previously considered as a relative contraindication for PAH patients , a growing body of research has found that exercise rehabilitation is safe and effective for them. Patients show greater improvement in their symptoms and quality of life. Effective and appropriate exercise rehabilitation in low- and middle-income countries can maximise the therapeutic benefits of targeted medication, improve patient survival rate, and enhance exercise tolerance and cardiorespiratory fitness. In this study, we will investigate the continuous effects of exercise rehabilitation on the clinical improvement (time to clinical improvement, TTCI) and cardiorespiratory fitness over a 1-year period of long-term rehabilitation, including aerobic training (aerobic power cycling and treadmill walking) and inspiratory muscle training (respiratory trainer and lip-contracting abdominal breathing).
- Conditions
- Pulmonary Hypertension
- Being tested
- Rehabilitation Training
- Keywords
- Rehabilitation, Pumonary arterial hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation TrainingOther
The rehabilitation training has two parts: the exercise training at home（5 times per week, as well as the Inspiratory muscle training(once per day) including Respiratory trainer exercise and abdominal breathing training.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation training | Experimental | open label Receives: Other: Rehabilitation Training |
| control | No intervention | open label |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk distance（ 6MWD）
The walk distance of patients in 6 minutes
Measured: every 3 months, until 6 months
Improved Time To Clinical Improvement(ITTWI)
The time that required from the time of rehabilitation training to the first occurrence of at least one stratum improvement of the weber classification
Measured: every 3 months, until 6months
Secondary outcomes (6)
Echocardiographic index---right ventricle
TAPSE, right ventricular diameter, tricuspid annular systolic motion s'
Measured: every 3 months, until 6 months
Echocardiographic index---left ventricle
left intraventricular diameter, diastolic left ventricular eccentricity index, systolic left ventricular eccentricity index
Measured: every 3 months, until 6 months
Echocardiographic index---left ventricle
TAPSE/PASP
Measured: every 3 months, until 6months
CPET index
AT, VE/VCO2 slope, PetCO2, oxygen pulse (VO2/HR), peak oxygen uptake (peak VO2),VE/VO2,PetO2
Measured: every 3 months, until 6months
SF-36 score
SF-36 is a scale for evaluating the life quality of PAH patients
Measured: every 3 months, until 6months
Echocardiographic index-others
RVFAC（right ventricle fraction of area changes）, diameter of pulmonary artery
Measured: every 3 months, until 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Model description
- The recruited patients were divided into two groups after random allocation. Group C (control): this group was the control group, in which patients did not receive rehabilitation training; they only received targeted drug therapy, health education and daily activities. Group T (treatment): this group of subjects is the treatment group, in the treatment group, in addition to receiving targeted drug therapy, daily activities, but also under medical supervision to carry out appropriate rehabilitation training.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Jieyan Shen, PhD, Study chair, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149935
- Sponsor's protocol ID
- Rehabilitation of PAH
- Status last verified
- Aug 2025
- First submitted
- 5 Jun 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Effect Of Long-Term Rehabilitation Training On Clinical Improvement(TTCI) And Cardiopulmonary Function In Pulmonary Arterial Hypertension Patients- A Multicenter-randomisation Study
- ClinicalTrials.gov ID
- NCT07149935
- Acronym / sponsor ID
- Rehabilitation of PAH
- Conditions
- Pulmonary Hypertension
- Keywords
- Rehabilitation, Pumonary arterial hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Sep 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.
This multicenter, open label, double-arm study aims at investigating the the continuous effect of long-Term rehabilitation training on clinical improvement(ITTCI) and cardiopulmonary function in pulmonary arterial hypertension patients
Detailed description
Pulmonary Arterial Hypertension (PAH) is a disease caused by various reasons leading to pulmonary vascular remodelling and then results in a progressive increase in pulmonary vascular resistance and right heart failure. PAH progresses rapidly,with a poor prognosis. Targeted drugs has brought about an improvement in the quality of life of patients with PAH. However, in most cases, patients' clinical symptoms will be gradually worsen with exercise capacity gradually declining. The prognosis of PAH remains bleak. Although exercise was previously considered as a relative contraindication for PAH patients , a growing body of research has found that exercise rehabilitation is safe and effective for them. Patients show greater improvement in their symptoms and quality of life. Effective and appropriate exercise rehabilitation in low- and middle-income countries can maximise the therapeutic benefits of targeted medication, improve patient survival rate, and enhance exercise tolerance and cardiorespiratory fitness. In this study, we will investigate the continuous effects of exercise rehabilitation on the clinical improvement (time to clinical improvement, TTCI) and cardiorespiratory fitness over a 1-year period of long-term rehabilitation, including aerobic training (aerobic power cycling and treadmill walking) and inspiratory muscle training (respiratory trainer and lip-contracting abdominal breathing).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The recruited patients were divided into two groups after random allocation. Group C (control): this group was the control group, in which patients did not receive rehabilitation training; they only received targeted drug therapy, health education and daily activities. Group T (treatment): this group of subjects is the treatment group, in the treatment group, in addition to receiving targeted drug therapy, daily activities, but also under medical supervision to carry out appropriate rehabilitation training.
| Arm | Type | Receives |
|---|---|---|
| rehabilitation training | Experimental | Other: Rehabilitation Trainingopen label |
| control | No intervention | –open label |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who suffered from pre-capillary PAH (mPAP ≥ 20 mmHg, PVR > 2 Woods unit, PAWP ≤ 15 mmHg) confirmed by right heart catheterisation.
- Patients who are in the status of WHO-FC I-III.
- Patients between 18 and 75 years old
- Female subjects are not pregnant.
- Patients are treated with PAH-targeted drugs and are in a stable state and there is no progress of disease).
Key exclusion criteria (13 listed)
- Pulmonary vascular occlusive disease
- Respiratory diseases
- Ischaemic heart disease, complex congenital heart disease (e.g., tetralogy of Fallot, etc.), cardiomyopathy, valvular disease
- Active liver disease
- Severe kidney disease
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 |
|---|---|---|
| Rehabilitation TrainingThe rehabilitation training has two parts: the exercise training at home（5 times per week, as well as the Inspiratory muscle training(once per day) including Respiratory trainer exercise and abdominal breathing training. | Other | rehabilitation training |
Primary outcome
6 minutes walk distance（ 6MWD）
Time frame: every 3 months, until 6 months
The walk distance of patients in 6 minutes
Improved Time To Clinical Improvement(ITTWI)
Time frame: every 3 months, until 6months
The time that required from the time of rehabilitation training to the first occurrence of at least one stratum improvement of the weber classification
6 secondary outcomes
Echocardiographic index---right ventricle
Time frame: every 3 months, until 6 months
Echocardiographic index---left ventricle
Time frame: every 3 months, until 6 months
Echocardiographic index---left ventricle
Time frame: every 3 months, until 6months
CPET index
Time frame: every 3 months, until 6months
SF-36 score
Time frame: every 3 months, until 6months
Echocardiographic index-others
Time frame: every 3 months, until 6months
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 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.
Jieyan Shen, PhD study chair
Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Training in people with Pulmonary Hypertension, run by RenJi Hospital at 1 site in China.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. 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 China. 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 Jieyan Shen, PhD (13701864819 ext. +86, shenjieyan@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walk distance（ 6MWD） (time frame: every 3 months, until 6 months). The study lists 2 primary outcomes in all. 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 2025.