The Effect of Chan-Chuang Qigong on Fatigue, Exercise Capacity and Quality of Lifpatients With Heart Failure

NCT06521281 | Completed

• 1 other identifier: CHGH-IRB（946）111-25
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure NYHA Class II

Outcome Measures

Primary Outcomes (3)

• Use the Chinese version of Piper fatigue scale to assess fatigue levels.

  Use the Chinese version of Piper fatigue scale.There are 16 questions in total. Based on a four-point Likert scale, the minimum score is 16 points and the maximum total score is 64 points. The higher the score, the more serious the fatigue.

  before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention

• Use the Six Minute Walking Distance (6MWD) to assess the patient's exercise capacity.

  Use the Six Minute Walking Distance (6MWD) to assess the patient's exercise tolerance by measuring the distance the patient walks in a straight line on a surface above 30 meters for 6 minutes.

  before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention

• Use the Chinese version of the Minnesota Heart Failure Quality of Life to assess quality of life.

  Use the Chinese version of the Minnesota Heart Failure Quality of Life Questionnaire.There are 21 questions in total, scored from 0 to 5, with a total score of 105. The higher the score, the more serious the impact of the disease on life.

  before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention

Secondary Outcomes (2)

• heart function-Left ventricular ejection volume

  before the intervention as the baseline, and the twelfth week of intervention respectively

• heart function-Serum NT-pro BNP values

  before the intervention as the baseline, and the twelfth week of intervention respectively

Study Arms (2)

qigong group

EXPERIMENTAL

Patients in qigong group was given twice daily, every 15 minutes Chan-Chuang qigong

Behavioral: Chan-Chuang qigong

control group

NO INTERVENTION

control group received the regular care for heart failure patients

Interventions

Chan-Chuang qigong BEHAVIORAL

Twice daily, every 15 minutes Chan-Chuang qigong

qigong group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chia-Lin Hsieh: lead

Study Sites (1)

Hsieh Chia Lin

Taipei, 112, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant hand nurse

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 25, 2024
• Study Start: September 16, 2022
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

TW (1)