Clinical trial NCT06521281: The Effect of Chan-Chuang Qigong on Fatigue, Exercise Capacity and Quality of Lifpatients With Heart Failure
Official title: The Effect of Chan-Chuang Qigong on Fatigue, Exercise Capacity and Quality of Life in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure NYHA Class II
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to investigate the impact of Chan-Chuang Qigong on fatigue, exercise capacity, quality of life, and heart function in heart failure patients. The study recruited 72 heart failure patients from a medical center in northern Taiwan for an experimental study. The participants were randomly divided into two groups: patients in experimental group was given twice daily, every 15 minutes Chan-Chuang qigong, control group received the regular care for heart failure patients. Data was collected using the Piper Fatigue Scale, a six-minute walking test, and the Minnesota Living with Heart Failure Questionnaire before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention. It is hoped that through this study, we can understand the effect of Chan-Chuang qigong on improving fatigue, exercise capacity and quality of life in patients with heart failure, and provide an additional choice and reference for the treatment and care of patients with heart failure in the future, and recommend future treatment of heart failure.


Eligibility criteria: Inclusion Criteria:

1. at least 20 years of age.
2. Cardiology specialist diagnoses heart failure based on clinical examination
3. Heart failure classified as New York Heart Association class II (NYHA II)
4. Left ventricular ejection volume \<50% (HFmrEF and HFrEF)
5. According to the doctor's assessment, it is not appropriate to exercise
6. Clear consciousness and ability to communicate
7. Agree to participate in this study after explanation and sign the consent form

Exclusion Criteria:

1. Renal failure treated with hemodialysis
2. Severe arrhythmias, such as third-degree atrioventricular block, frequent ventricular pulses and heartbeats greater than 130 beats/min at rest
3. About to undergo coronary interventional surgery or cardiac surgery within 3 months
4. Coronary interventional surgery or cardiac surgery in the past 3 months

Primary outcomes:
measure: Use the Chinese version of Piper fatigue scale to assess fatigue levels.
timeFrame: before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention
measure: Use the Six Minute Walking Distance (6MWD) to assess the patient's exercise capacity.
timeFrame: before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention
measure: Use the Chinese version of the Minnesota Heart Failure Quality of Life to assess quality of life.
timeFrame: before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention
Secondary outcomes:
measure: heart function-Left ventricular ejection volume
timeFrame: before the intervention as the baseline, and the twelfth week of intervention respectively
measure: heart function-Serum NT-pro BNP values
timeFrame: before the intervention as the baseline, and the twelfth week of intervention respectively
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Hsieh Chia Lin
Study officials:
References: