Skip to main content
OpenTrials
Completed

NCT Number: NCT04981197

Effects of Baduanjin Exercise on Heart Failure Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Dyssomnias Fatigue Heart Diseases Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Baduanjin exercise

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2021
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.