Clinical trial NCT04981197: Effects of Baduanjin Exercise on Heart Failure Patients
Official title: Effects of Baduanjin Exercise on Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
Baduanjin exercise
fatigue
sleep quality
psychological distress
quality of life
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2021-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Changes in the modified Piper Fatigue Scale scores
timeFrame: baseline, 4 week, 8 week, 12 week
measure: Changes in the Minnesota Living with Heart Failure Questionnaire scores
timeFrame: baseline, 4 week, 8 week, 12 week
Secondary outcomes:
measure: Changes in the Pittsburgh Sleep Quality Index scores
timeFrame: baseline, 4 week, 8 week, 12 week
measure: Changes in the Hospital Anxiety and Depression Scale scores
timeFrame: baseline, 4 week, 8 week, 12 week
measure: Changes in heart rate variability
timeFrame: baseline, 4 week, 8 week, 12 week
Other outcomes:
Locations:
Study officials:
References: