Effects of Baduanjin Exercise on Heart Failure Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Primary Endpoint
- Changes in the modified Piper Fatigue Scale scores
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Changes in the modified Piper Fatigue Scale scores
Time Frame: baseline, 4 week, 8 week, 12 week
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.
Changes in the Minnesota Living with Heart Failure Questionnaire scores
Time Frame: baseline, 4 week, 8 week, 12 week
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.
Secondary Outcomes
- Changes in heart rate variability(baseline, 4 week, 8 week, 12 week)
- Changes in the Pittsburgh Sleep Quality Index scores(baseline, 4 week, 8 week, 12 week)
- Changes in the Hospital Anxiety and Depression Scale scores(baseline, 4 week, 8 week, 12 week)