Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension (PAH)

Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension to Enhance Exercise Tolerance ，Reduce Negative Emotions and Quality of Life: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Arterial Hypertension PAH
• Intervention / Treatment: Other: wu qinxi

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia ruoya; Phone Number: 15850516619; Email: 274991496@qq.com
• Study Contact Backup: Name: Chang yun; Phone Number: 15951670308; Email: dingww1998@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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'
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative emotions	PHQ-9/GAD-7	admission and discharge at the end of 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frail	Frail questionnaire	admission and discharge at the end of 3 months
Nutrition	Simple Nutrition Assessment (MNA)	admission and discharge at the end of 3 months
Sleep	Pittsburgh Sleep Quality Index (PSQI)	admission and discharge at the end of 3 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Chang yun, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: KY20240422-KS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No