Effects of Baduanjin Exercise on Heart Failure Patients

NCT04981197 | Completed

• 1 other identifier: 13-S-013
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

heart failure; Baduanjin exercise; fatigue; sleep quality; psychological distress; quality of life

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Changes in the Pittsburgh Sleep Quality Index scores

  baseline, 4 week, 8 week, 12 week

• Changes in the Hospital Anxiety and Depression Scale scores

  baseline, 4 week, 8 week, 12 week

• Changes in heart rate variability

  baseline, 4 week, 8 week, 12 week

Study Arms (2)

Baduanjin exercise group

EXPERIMENTAL

The Baduanjin exercise group received a 12-week Baduanjin exercise programme.

Behavioral: Baduanjin exercise

Control group

NO INTERVENTION

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

Interventions

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.

Baduanjin exercise group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Ministry of Science and Technology, Taiwan: collaborator

MeSH Terms

Conditions

Heart Failure; Fatigue; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: July 28, 2021
• Study Start: December 17, 2013
• Primary Completion: November 30, 2014
• Study Completion: November 30, 2014
• Last Updated: October 13, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share