Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension

NCT ID: NCT06454422

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-12-31

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.

Conditions

Pulmonary Arterial Hypertension PAH

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Wuqinxi

including observation of disease progression and complications, oxygen inhalation, medication guidance, rest and diet nursing, daily activity guidance, psychological guidance, and follow-up after discharge.

Patients mimicked precise Wuqinxi movements and breathing patterns while exercising.

Group Type: EXPERIMENTAL

wu qinxi

Intervention Type: OTHER

Wuqinxi, also known as the Hundred-step Sweating Exercise, is one of the most emblematic Health qigong exercises. Huatuo, guided by the principle, formulated the 'Wuqinxi': " Running water is never stale and a door-hinge is never gets worm-eaten," and sums up the experiences of the fitness activities of Huatuo's predecessors that imitate the movements of tigers, deer, bears, apes, birds, and other animals, and are associated with human organs, meridians, and 'qi'

general nursing routines

including observation of disease progression and complications, oxygen inhalation, medication guidance, rest and diet nursing, daily activity guidance, psychological guidance, and follow-up after discharge.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

wu qinxi

Wuqinxi, also known as the Hundred-step Sweating Exercise, is one of the most emblematic Health qigong exercises. Huatuo, guided by the principle, formulated the 'Wuqinxi': " Running water is never stale and a door-hinge is never gets worm-eaten," and sums up the experiences of the fitness activities of Huatuo's predecessors that imitate the movements of tigers, deer, bears, apes, birds, and other animals, and are associated with human organs, meridians, and 'qi'

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang yun

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Jia ruoya

Role: CONTACT

274991496@qq.com

15850516619

Chang yun

Role: CONTACT

dingww1998@163.com

15951670308

Other Identifiers

KY20240422-KS-01

Identifier Type: -

Identifier Source: org_study_id