Heart Failure
Conditions
Keywords
heart failure, Baduanjin exercise, fatigue, sleep quality, psychological distress, quality of life
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.
Interventions
BEHAVIORALBaduanjin exercise
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.
Sponsors
Ministry of Science and Technology, Taiwan
National Yang Ming Chiao Tung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the modified Piper Fatigue Scale scores | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Pittsburgh Sleep Quality Index scores | baseline, 4 week, 8 week, 12 week | 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. |
| Changes in the Hospital Anxiety and Depression Scale scores | baseline, 4 week, 8 week, 12 week | 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 |
| Changes in heart rate variability | baseline, 4 week, 8 week, 12 week | 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) |
Outcome results
None listed