Effects of Baduanjin Exercise on Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT04981197
• Lead Sponsor: National Yang Ming Chiao Tung University

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 Timeline

• Study Start: 2013-12-17
• Primary Completion: 2014-11-30
• Study Completion: 2014-11-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-18
• Study First Submitted QC: 2021-07-18
• Study First Posted: 2021-07-28
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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