Effects of Baduanjin Exercise on Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Effects of Baduanjin Exercise on Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981197
• Other study ID #: 13-S-013
• Status: Completed
• Phase: N/A
• Start date: December 17, 2013
• Est. completion date: November 30, 2014

Study information

• Verified date: July 2021
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 30, 2014
• Est. primary completion date: November 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 4 week, 8 week, 12 week
Primary	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.	baseline, 4 week, 8 week, 12 week
Secondary	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.	baseline, 4 week, 8 week, 12 week
Secondary	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	baseline, 4 week, 8 week, 12 week
Secondary	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)	baseline, 4 week, 8 week, 12 week