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Clinical Trial NCT07149935 for Pulmonary Hypertension is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients 104 Open-Label

Recruiting
Clinical Trial NCT07149935 is an interventional study for Pulmonary Hypertension that is recruiting. It started on 1 September 2024 with plans to enroll 104 participants. Led by RenJi Hospital, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 2 September 2025.
Brief 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
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 g...Show More
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

Conditions
Pulmonary Hypertension
Other Study IDs
  • Rehabilitation of PAH
NCT ID Number
NCT07149935
Start Date (Actual)
2024-09-01
Last Update Posted
2025-09-02
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
104
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Rehabilitation, Pumonary arterial hypertension
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalrehabilitation training
open label
Rehabilitation Training
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.
No Interventioncontrol
open label
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
6 minutes walk distance（ 6MWD）
The walk distance of patients in 6 minutes
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
every 3 months, until 6months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Echocardiographic index---right ventricle
TAPSE, right ventricular diameter, tricuspid annular systolic motion s'
every 3 months, until 6 months
Echocardiographic index---left ventricle
left intraventricular diameter, diastolic left ventricular eccentricity index, systolic left ventricular eccentricity index
every 3 months, until 6 months
Echocardiographic index---left ventricle
TAPSE/PASP
every 3 months, until 6months
CPET index
AT, VE/VCO2 slope, PetCO2, oxygen pulse (VO2/HR), peak oxygen uptake (peak VO2),VE/VO2,PetO2
every 3 months, until 6months
SF-36 score
SF-36 is a scale for evaluating the life quality of PAH patients
every 3 months, until 6months
Echocardiographic index-others
RVFAC（right ventricle fraction of area changes）, diameter of pulmonary artery
every 3 months, until 6months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Patients who suffered from pre-capillary PAH (mPAP ≥ 20 mmHg, PVR > 2 Woods unit, PAWP ≤ 15 mmHg) confirmed by right heart catheterisation.
  2. Patients who are in the status of WHO-FC I-III.
  3. Patients between 18 and 75 years old
  4. Female subjects are not pregnant.
  5. Patients are treated with PAH-targeted drugs and are in a stable state and there is no progress of disease).
  6. Patients have not received exercise rehabilitation training within six months.

Patients with the following diseases or symptoms:

  1. Pulmonary vascular occlusive disease
  2. Respiratory diseases
  3. Ischaemic heart disease, complex congenital heart disease (e.g., tetralogy of Fallot, etc.), cardiomyopathy, valvular disease
  4. Active liver disease
  5. Severe kidney disease
  6. Motor disorders (e.g. lower limb fracture, ataxia, etc.)
  7. Malignant tumour diseases
  8. Physical disability
  9. Hb ≤ 80g / L
  10. Systolic blood pressure ≤85mmHg
  11. History of syncope within 3 months
  12. History of supraventricular or ventricular arrhythmia at rest within 3 months.
RenJi Hospital logoRenJi Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China logoShanghai Pulmonary Hospital, Shanghai, China
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine logoShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study Central Contact
Contact: Jieyan Shen, PhD, 13701864819, [email protected]
1 Study Locations in 1 Countries

Shanghai Municipality

Renji Hospital, Shanghai, Shanghai Municipality, 210007, China
Jun Tong, postgra, Contact, 19121913396, [email protected]
Recruiting