Effects of Baduanjin Exercise on Heart Failure Patients

Study Overview
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Brief Summary
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This study was a parallel, randomized controlled trial with a longitudinal research design. Participants were randomly assigned to either the Baduanjin exercise group or the control group. The Baduanjin exercise group received a 12-week Baduanjin exercise programme. The control group received usual care. Fatigue, sleep quality, psychological distress, quality of life were assessed by a structured questionnaire at baseline, 4 weeks, 8 weeks, and 12 weeks after enrollment.

Detailed Description
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This study was a parallel, randomized controlled trial with a longitudinal research design. Participants were randomly assigned to either the Baduanjin exercise group or the control group. Patients in the intervention group underwent a 12-week Baduanjin exercise programme consisting of 12 weeks of Baduanjin exercise, a 35-min Baduanjin exercise demonstration video, a picture-based educational brochure, and a performance record form. The control group received usual care. Fatigue, sleep quality, psychological distress, quality of life were assessed by a structured questionnaire at baseline, 4 weeks, 8 weeks, and 12 weeks after enrollment.

Official Title
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Effects of Baduanjin Exercise on Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Baduanjin exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with stable heart failure by a physician according to the New York Heart Association (NYHA) class I and II Aged 20 years or older Able to communicate and speak Chinese Have video devices available to use at home Exclusion Criteria: Impaired mobility, defined as a limitation in independent, purposeful physical movement of the body or of one or more extremities Unstable angina or myocardial infarction, unstable serious arrhythmia, unstable structural valvular disease, open-heart surgery, or chronic obstructive pulmonary disease (COPD) Diagnosis of major depression and cognitive disorders Unstable vital signs (defined as blood pressure > 180/110 mmHg or < 90/60 mmHg and resting heart rate > 100 beats/min).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baduanjin exercise group<br>The Baduanjin exercise group received a 12-week Baduanjin exercise programme. | Behavioral: Baduanjin exercise<br>* Patients in the intervention group underwent a 12-week Baduanjin exercise programme consisting of 12 weeks of Baduanjin exercise, a 35-min Baduanjin exercise demonstration video, a picture-based educational brochure, and a performance record form.<br>|
| No Intervention: Control group<br>Patients in this group maintain their daily life activities, and there is no intervention given. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the modified Piper Fatigue Scale scores | Changes from baseline modified Piper Fatigue scale at 4 weeks, 8 weeks, 12 weeks.The shortened modified Piper Fatigue scale is composed of 15 items that measure two domains of fatigue: severity and temporality. Each item is scored from 0 to 3, with a total possible score of 0-45. Higher scores indicate greater fatigue. | baseline, 4 week, 8 week, 12 week | 
| Changes in the Minnesota Living with Heart Failure Questionnaire scores | Changes from baseline Minnesota Living with Heart Failure Questionnaire at 4 weeks, 8 weeks, 12 weeks.The Minnesota Living with Heart Failure Questionnaire is composed of 21 items. Each item score ranges from 0 to 5. The total possible score ranges from 0 to 105, with higher scores indicating a lower quality of life. | baseline, 4 week, 8 week, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Pittsburgh Sleep Quality Index scores | Changes from baseline Pittsburgh Sleep Quality Index at 4 weeks, 8 weeks, 12 weeks.The Pittsburgh Sleep Quality Index is composed of 21 items, 7 dimensions. Each dimension is scored from 0 to 3, with a total possible score of 0-21. Higher scores indicate poor sleep. | baseline, 4 week, 8 week, 12 week | 
| Changes in the Hospital Anxiety and Depression Scale scores | Changes from baseline Hospital Anxiety and Depression Scale at 4 weeks, 8 weeks, 12 weeks.The Hospital Anxiety and Depression Scale is composed of 14 items, 2 subscales. Each item is scored from 0 to 3, with a total possible score of 0-21 for each subscale. Higher scores indicate higher anxiety and depression | baseline, 4 week, 8 week, 12 week | 
| Changes in heart rate variability | Changes from baseline heart rate variability at 4 weeks, 8 weeks, 12 weeks.The heart rate variability was measured using the Heart Rate Master ANSWatch® Wrist Physiological Monitor TS-0411Deluxe Advanced (made in Taiwan) | baseline, 4 week, 8 week, 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, Baduanjin exercise, fatigue, sleep quality, psychological distress, quality of life