Clinical trial NCT06454422: Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension
Official title: Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension to Enhance Exercise Tolerance ，Reduce Negative Emotions and Quality of Life: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension PAH
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims and objective: The primary objective of this study was to assess the effects of a traditional Chinese Qigong practice known as Wuqinxi on activity tolerance，negative emotions and quality of life in pulmonary arterial hypertension patients.

Methods: In the current prospective, randomized-controlled clinical trial, 60 patients with pulmonary arterial hypertension were randomly assigned to one of two groups: intervention or control. Participants in the intervention group received targeted pharmacological therapy and five sessions of qigong exercise per week. In contrast, individuals in the control group underwent targeted drug therapy and routine care. Observe the change in exercise tolerance as measured by the 6-minute walking distance (6MWD). Serological indicators (n-terminal brain natriuretic peptide precursor, NT-pro BNP) ,negative emotions(PHQ-9/GAD-7)and the MOS Item Short Form Health Survey (SF-36) or emPHasis-10 were used to assess patients condition and quality of life.

Detailed description: In the previous study, we examined the effects of comprehensive respiratory function exercise on exercise tolerance in patients with PAH. The results indicated that limb exercise combined with breath regulating guidance affects patients' physical health.Given these TCM principles, the current study investigated the clinical utility of Wuqinxi for improving patients' exercise tolerance and quality of life by comparing the intervention and control groups' NT-pro BNP scores, 6MWD data, negative emotionsand quality of life indices.

Eligibility criteria: Inclusion Criteria:

* (1) patients with PAH related to IPAH(idiopathic pulmonary arterial), CTD(connective tissue disease), DPAH(drug-induced pulmonary hypertension), CHD(congenital heart disease) and associated with secondary disease, aged 18-75 years; (2)patients with PAH as defined by the American College of Cardiology Foundation/American Heart Association (right heart catheterization: mPAP≥20mmHg and PAWP≤15mmHg); (3) patients with WHO pulmonary arterial hypertension functional class II-III; (4) patients on drug-based treatment for ≥1 month and in the recovery period; (5) could read, write, and comprehend Chinese; (6) volunteered for this trial and provided written informed consent.

Exclusion Criteria:

* (1) patients unable or unwilling to complete the 6MWD; (2) The physician confirms that the disease requires bed rest or with severely impaired cardiopulmonary function, tumors, and limb dysfunction; (3) patients who were unable to complete the questionnaire independently; (4) a history of mental problems and cognitive impairment; or have had psychotherapy or taken any psychiatric medication in the past or present.(5) patients who were hospitalized with severe disease.

Primary outcomes:
measure: Biomarker
timeFrame: admission and discharge at the end of 3 months
measure: 6-minute walking distance
timeFrame: admission and discharge at the end of 3 months
measure: Quality of Life Assessment
timeFrame: admission and discharge at the end of 3 months
Secondary outcomes:
measure: Negative emotions
timeFrame: admission and discharge at the end of 3 months
Other outcomes:
measure: Frail
timeFrame: admission and discharge at the end of 3 months
measure: Nutrition
timeFrame: admission and discharge at the end of 3 months
measure: Sleep
timeFrame: admission and discharge at the end of 3 months
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Chang yun
role: STUDY_CHAIR
References: