Back to resultsEffects of Baduanjin Exercise on Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Baduanjin exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, Baduanjin exercise, fatigue, sleep quality, psychological distress, quality of life
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Baduanjin exercise group
Control group
Arm Description
The Baduanjin exercise group received a 12-week Baduanjin exercise programme.
Patients in this group maintain their daily life activities, and there is no intervention given.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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
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)
Full Information
NCT ID
NCT04981197
First Posted
July 18, 2021
Last Updated
October 12, 2022
Sponsor
National Yang Ming University
Collaborators
Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04981197
Brief Title
Effects of Baduanjin Exercise on Heart Failure Patients
Official Title
Effects of Baduanjin Exercise on Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2013 (Actual)
Primary Completion Date
November 30, 2014 (Actual)
Study Completion Date
November 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Ministry of Science and Technology, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, Baduanjin exercise, fatigue, sleep quality, psychological distress, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baduanjin exercise group
Arm Type
Experimental
Arm Description
The Baduanjin exercise group received a 12-week Baduanjin exercise programme.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in this group maintain their daily life activities, and there is no intervention given.
Intervention Type
Behavioral
Intervention Name(s)
Baduanjin exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the modified Piper Fatigue Scale scores
Description
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.
Time Frame
baseline, 4 week, 8 week, 12 week
Title
Changes in the Minnesota Living with Heart Failure Questionnaire scores
Description
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.
Time Frame
baseline, 4 week, 8 week, 12 week
Secondary Outcome Measure Information:
Title
Changes in the Pittsburgh Sleep Quality Index scores
Description
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.
Time Frame
baseline, 4 week, 8 week, 12 week
Title
Changes in the Hospital Anxiety and Depression Scale scores
Description
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
Time Frame
baseline, 4 week, 8 week, 12 week
Title
Changes in heart rate variability
Description
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)
Time Frame
baseline, 4 week, 8 week, 12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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).
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Baduanjin Exercise on Heart Failure Patients
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