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Effects of Baduanjin Exercise on Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT04981197
Recruitment Status : Completed
First Posted : July 28, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
National Yang Ming 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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Baduanjin exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Baduanjin Exercise on Heart Failure Patients
Actual Study Start Date : December 17, 2013
Actual Primary Completion Date : November 30, 2014
Actual Study Completion Date : November 30, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Baduanjin exercise group
The Baduanjin exercise group received a 12-week Baduanjin exercise programme.
Behavioral: Baduanjin 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.

No Intervention: Control group
Patients in this group maintain their daily life activities, and there is no intervention given.



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Changes in the Pittsburgh Sleep Quality Index scores [ Time Frame: 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.

  2. Changes in the Hospital Anxiety and Depression Scale scores [ Time Frame: 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

  3. Changes in heart rate variability [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) diagnosed with stable heart failure by a physician according to the New York Heart Association (NYHA) class I and II; (2) aged 20 years or older; (3) able to communicate and speak Chinese; and (4) have video devices available to use at home.

Exclusion Criteria:

  • (1) impaired mobility, defined as a limitation in independent, purposeful physical movement of the body or of one or more extremities; (2) unstable angina or myocardial infarction, unstable serious arrhythmia, unstable structural valvular disease, open-heart surgery, or chronic obstructive pulmonary disease (COPD); (3) diagnosis of major depression and cognitive disorders; or (4) unstable vital signs (defined as blood pressure > 180/110 mmHg or < 90/60 mmHg and resting heart rate > 100 beats/min).
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Responsible Party: National Yang Ming University
ClinicalTrials.gov Identifier: NCT04981197    
Other Study ID Numbers: 13-S-013
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Yang Ming University:
heart failure
Baduanjin exercise
fatigue
sleep quality
psychological distress
quality of life
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases