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

July 24, 2024 updated by: Chia-Lin Hsieh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Hsieh Chia Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: qigong group
Patients in qigong group was given twice daily, every 15 minutes Chan-Chuang qigong
Behavioral: Chan-Chuang qigong
Twice daily, every 15 minutes Chan-Chuang qigong
No Intervention: control group
control group received the regular care for heart failure patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use the Chinese version of Piper fatigue scale to assess fatigue levels.
Time Frame: before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention
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.
Time Frame: 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 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.
Time Frame: 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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart function-Left ventricular ejection volume
Time Frame: before the intervention as the baseline, and the twelfth week of intervention respectively
Left ventricular ejection volume were collected by reviewing medical records.
before the intervention as the baseline, and the twelfth week of intervention respectively
heart function-Serum NT-pro BNP values
Time Frame: before the intervention as the baseline, and the twelfth week of intervention respectively
Serum NT-pro BNP values were collected by reviewing medical records.
before the intervention as the baseline, and the twelfth week of intervention respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia-Lin Hsieh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

November 25, 2023

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHGH-IRB（946）111-25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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