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NCT Number: NCT07149935

Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 210007, China

Location status: Recruiting

Location contact

Jun Tong, postgra

CONTACT

[email protected]

19121913396

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

  1. 6 minutes walk distance( 6MWD)

    Time frame: every 3 months, until 6 months

    The walk distance of patients in 6 minutes

  2. 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

Secondary outcomes

  1. Echocardiographic index---right ventricle

    Time frame: every 3 months, until 6 months

    TAPSE, right ventricular diameter, tricuspid annular systolic motion s'

  2. Echocardiographic index---left ventricle

    Time frame: every 3 months, until 6 months

    left intraventricular diameter, diastolic left ventricular eccentricity index, systolic left ventricular eccentricity index

  3. Echocardiographic index---left ventricle

    Time frame: every 3 months, until 6months

    TAPSE/PASP

  4. CPET index

    Time frame: every 3 months, until 6months

    AT, VE/VCO2 slope, PetCO2, oxygen pulse (VO2/HR), peak oxygen uptake (peak VO2),VE/VO2,PetO2

  5. SF-36 score

    Time frame: every 3 months, until 6months

    SF-36 is a scale for evaluating the life quality of PAH patients

  6. Echocardiographic index-others

    Time frame: every 3 months, until 6months

    RVFAC(right ventricle fraction of area changes), diameter of pulmonary artery

Study contacts

Contact information is provided by the study sponsor or research team.

Jieyan Shen, PhD

CONTACT

[email protected]

13701864819 ext. +86

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Pulmonary Hospital, Shanghai, China

Registry information

Official study title

Continuous Effect Of Long-Term Rehabilitation Training On Clinical Improvement(TTCI) And Cardiopulmonary Function In Pulmonary Arterial Hypertension Patients- A Multicenter-randomisation Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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