Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients

NCT07149935 | Recruiting

• 1 other identifier: Rehabilitation of PAH
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Hypertension

Keywords

Rehabilitation, Pumonary arterial hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Echocardiographic index---right ventricle

  every 3 months, until 6 months

• Echocardiographic index---left ventricle

  every 3 months, until 6 months

• Echocardiographic index---left ventricle

  every 3 months, until 6months

• CPET index

  every 3 months, until 6months

• SF-36 score

  every 3 months, until 6months

Study Arms (2)

rehabilitation training

EXPERIMENTAL

open label

Other: Rehabilitation Training

control

NO INTERVENTION

open label

Interventions

Rehabilitation Training OTHER

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.

rehabilitation training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 210007, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jieyan Shen, PhD

  Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

  STUDY CHAIR

Central Study Contacts

Jieyan Shen, PhD

CONTACT

13701864819; shenjieyan@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the specificity of rehabilization, it is not suitable for us to mask
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: September 2, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)