Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension

NCT06454422 | Not Yet Recruiting DMC

• 1 other identifier: KY20240422-KS-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Arterial Hypertension PAH

Outcome Measures

Primary Outcomes (3)

• Biomarker

  NT-pro BNP was detected using a colloidal gold immunochromatography analyzer, model LEPU Quant 800, made in Beijing, China.

  admission and discharge at the end of 3 months

• 6-minute walking distance

  The 6MWD test for selected patients with stable illness was conducted in the corridor of the cardiology ward

  admission and discharge at the end of 3 months

• Quality of Life Assessment

  emPHasis-10 or pulmonary hypertension health quality of life score, SF-36

  admission and discharge at the end of 3 months

Secondary Outcomes (1)

• Negative emotions

  admission and discharge at the end of 3 months

Other Outcomes (3)

• Frail

  admission and discharge at the end of 3 months

• Nutrition

  admission and discharge at the end of 3 months

• Sleep

  admission and discharge at the end of 3 months

Study Arms (2)

Wuqinxi

EXPERIMENTAL

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.

Other: wu qinxi

general nursing routines

NO INTERVENTION

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.

Interventions

wu qinxi 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'

Wuqinxi

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Officials

• Chang yun

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Jia ruoya

CONTACT

15850516619; 274991496@qq.com

Chang yun

CONTACT

15951670308; dingww1998@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share