Heart Failure NYHA Class IINCT06521281
The Effect of Chan-Chuang Qigong on Fatigue, Exercise Capacity and Quality of Lifpatients With Heart Failure
A study testing Chan-Chuang qigong in people with Heart Failure NYHA Class II, run by Chia-Lin Hsieh at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure NYHA Class II
- What is being tested?
- Chan-Chuang qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2022to 25 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heart Failure NYHA Class II
- Being tested
- Chan-Chuang qigong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chan-Chuang qigongBehavioural
Twice daily, every 15 minutes Chan-Chuang qigong
| Study group | Role | What they receive |
|---|---|---|
| qigong group | Experimental | Patients in qigong group was given twice daily, every 15 minutes Chan-Chuang qigong Receives: Behavioral: Chan-Chuang qigong |
| control group | No intervention | control group received the regular care for heart failure patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Left ventricular ejection volume were collected by reviewing medical records.
Measured: before the intervention as the baseline, and the twelfth week of intervention respectively
heart function-Serum NT-pro BNP values
Serum NT-pro BNP values were collected by reviewing medical records.
Measured: before the intervention as the baseline, and the twelfth week of intervention respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start16 Sep 2022
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia-Lin Hsieh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chia-Lin Hsieh, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521281
- Sponsor's protocol ID
- CHGH-IRB（946）111-25
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chan-Chuang Qigong on Fatigue, Exercise Capacity and Quality of Life in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06521281
- Acronym / sponsor ID
- CHGH-IRB（946）111-25
- Conditions
- Heart Failure NYHA Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chia-Lin HsiehUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| qigong group | Experimental | Behavioral: Chan-Chuang qigongPatients in qigong group was given twice daily, every 15 minutes Chan-Chuang qigong |
| control group | No intervention | –control group received the regular care for heart failure patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chan-Chuang qigongTwice daily, every 15 minutes Chan-Chuang qigong | Behavioural | qigong group |
Primary outcome
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.
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.
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.
2 secondary outcomes
heart function-Left ventricular ejection volume
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chan-Chuang qigong in people with Heart Failure NYHA Class II, run by Chia-Lin Hsieh at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.