Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT07149935
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Because the specificity of rehabilization, it is not suitable for us to mask'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The recruited patients were divided into two groups after random allocation.\n\nGroup 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.\n\nGroup 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2025-08-24', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minutes walk distance（ 6MWD）', 'timeFrame': 'every 3 months, until 6 months', 'description': 'The walk distance of patients in 6 minutes'}, {'measure': 'Improved Time To Clinical Improvement(ITTWI)', 'timeFrame': 'every 3 months, until 6months', 'description': 'The time that required from the time of rehabilitation training to the first occurrence of at least one stratum improvement of the weber classification'}], 'secondaryOutcomes': [{'measure': 'Echocardiographic index---right ventricle', 'timeFrame': 'every 3 months, until 6 months', 'description': "TAPSE, right ventricular diameter, tricuspid annular systolic motion s'"}, {'measure': 'Echocardiographic index---left ventricle', 'timeFrame': 'every 3 months, until 6 months', 'description': 'left intraventricular diameter, diastolic left ventricular eccentricity index, systolic left ventricular eccentricity index'}, {'measure': 'Echocardiographic index---left ventricle', 'timeFrame': 'every 3 months, until 6months', 'description': 'TAPSE/PASP'}, {'measure': 'CPET index', 'timeFrame': 'every 3 months, until 6months', 'description': 'AT, VE/VCO2 slope, PetCO2, oxygen pulse (VO2/HR), peak oxygen uptake (peak VO2),VE/VO2,PetO2'}, {'measure': 'SF-36 score', 'timeFrame': 'every 3 months, until 6months', 'description': 'SF-36 is a scale for evaluating the life quality of PAH patients'}, {'measure': 'Echocardiographic index-others', 'timeFrame': 'every 3 months, until 6months', 'description': 'RVFAC（right ventricle fraction of area changes）, diameter of pulmonary artery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation, Pumonary arterial hypertension'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who suffered from pre-capillary PAH (mPAP ≥ 20 mmHg, PVR \\> 2 Woods unit, PAWP ≤ 15 mmHg) confirmed by right heart catheterisation.\n2. Patients who are in the status of WHO-FC I-III.\n3. Patients between 18 and 75 years old\n4. Female subjects are not pregnant.\n5. Patients are treated with PAH-targeted drugs and are in a stable state and there is no progress of disease).\n6. Patients have not received exercise rehabilitation training within six months.\n\nExclusion Criteria:\n\nPatients with the following diseases or symptoms:\n\n1. Pulmonary vascular occlusive disease\n2. Respiratory diseases\n3. Ischaemic heart disease, complex congenital heart disease (e.g., tetralogy of Fallot, etc.), cardiomyopathy, valvular disease\n4. Active liver disease\n5. Severe kidney disease\n6. Motor disorders (e.g. lower limb fracture, ataxia, etc.)\n7. Malignant tumour diseases\n8. Physical disability\n9. Hb ≤ 80g / L\n10. Systolic blood pressure ≤85mmHg\n11. History of syncope within 3 months\n12. History of supraventricular or ventricular arrhythmia at rest within 3 months.'}, 'identificationModule': {'nctId': 'NCT07149935', 'briefTitle': 'Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Continuous Effect Of Long-Term Rehabilitation Training On Clinical Improvement(TTCI) And Cardiopulmonary Function In Pulmonary Arterial Hypertension Patients- A Multicenter-randomisation Study', 'orgStudyIdInfo': {'id': 'Rehabilitation of PAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rehabilitation training', 'description': 'open label', 'interventionNames': ['Other: Rehabilitation Training']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'open label'}], 'interventions': [{'name': 'Rehabilitation Training', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['rehabilitation training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210007', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Tong, postgra', 'role': 'CONTACT', 'email': 'tj0129@sjtu.edu.cn', 'phone': '19121913396'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jieyan Shen, PhD', 'role': 'CONTACT', 'email': 'shenjieyan@renji.com', 'phone': '13701864819', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Jieyan Shen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}