Pulmonary Hypertension
Conditions
Keywords
Rehabilitation, Pumonary arterial hypertension
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 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).
Interventions
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.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Because the specificity of rehabilization, it is not suitable for us to mask
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 minutes walk distance（ 6MWD） | every 3 months, until 6 months | The walk distance of patients in 6 minutes |
| Improved Time To Clinical Improvement(ITTWI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Echocardiographic index---right ventricle | every 3 months, until 6 months | TAPSE, right ventricular diameter, tricuspid annular systolic motion s' |
| CPET index | every 3 months, until 6months | AT, VE/VCO2 slope, PetCO2, oxygen pulse (VO2/HR), peak oxygen uptake (peak VO2),VE/VO2,PetO2 |
| Echocardiographic index-others | every 3 months, until 6months | RVFAC（right ventricle fraction of area changes）, diameter of pulmonary artery |
| Echocardiographic index---left ventricle | every 3 months, until 6 months | left intraventricular diameter, diastolic left ventricular eccentricity index, systolic left ventricular eccentricity index |
| SF-36 score | every 3 months, until 6months | SF-36 is a scale for evaluating the life quality of PAH patients |
Countries
China
Contacts
Primary ContactJieyan Shen, PhD
Outcome results
None listed