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Baduanjin mind-body exercise for cancer-related fatigue

Baduanjin mind-body exercise for cancer-related fatigue in cancer participants receiving adjuvant chemotherapy: a randomised control feasibility trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000177651
Enrollment
13
Registered
2023-02-21
Start date
2024-05-25
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this research is to examine the feasibility and acceptability of Baduanjin mind-body exercise for the management of cancer-related fatigue (CRF). Cancer-related fatigue is a persistent, subjective sense of physical, emotional and/or cognitive tiredness or exhaustion related to cancer or cancer treatment, and which interferes with a person’s everyday usual functioning in life. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older with cancer who is receiving adjuvant chemotherapy or has recently completed adjuvant chemotherapy who is suffering from moderate cancer-related fatigue. Study details Participants will be randomly allocated to one of two treatments: The intervention group will commence Baduanjin mind-body exercise program for 8 weeks (17-20 mins per session, twice a day for 6 days a week) starting at enrolment. The waitlist control group will continue without modifications to their usual care and undergo no Baduanjin mind-body exercise (however at the end of their waitlist, they are able to participate in the Baduanjin mind-body exercise program but not as a participant). As part of this study, both intervention and waitlist control groups will be asked to complete questionnaires at week 0 (baseline), week 4 (midpoint), week 8 (final week) and week 9 (1 week follow-up). It is hoped that the remote delivery of Badjuanjin mind-body exercise is a feasible home-based program for people with CRF.

Interventions

Baduanjin mind-body exercise involves a set of gentle aerobic exercises involving mental focus with controlled breathing while performing a sequenced set of coordinated physical movements. According to the American Sports Medicine Association and the American Centres for Disease Control and Prevention, Baduanjin MBE is a low-intensity exercise. Baduanjin mind-body exercise program is in addition to a participant’s standard care. There are no changes to a participant’s usual care practices. Par

Baduanjin mind-body exercise involves a set of gentle aerobic exercises involving mental focus with controlled breathing while performing a sequenced set of coordinated physical movements. According to the American Sports Medicine Association and the American Centres for Disease Control and Prevention, Baduanjin MBE is a low-intensity exercise. Baduanjin mind-body exercise program is in addition to a participant’s standard care. There are no changes to a participant’s usual care practices. Participants commencing the exercise program will have a meeting with a research team member (in week 0), who will organise delivery of the information pack and resources in advance of the participant commencing their Baduanjin mind-body exercise in Week 1. An introductive session (30-minute) is held for participants individually, which is comprised of an introduction to the Baduanjin mind-body exercise program, guidelines for performing the exercise movements, instructions related to the Exercise Logbook to record the completion of the daily exercise routine. The picture-based Instruction Handbook (brochure) displaying the movements and Baduanjin mind-body exercise online demonstration video link will be provided to the patient in Week 1. The picture-based Instruction Handbook (brochure) and Exercise Logbook are sent to the participant by email (only mailing hard copies as required). The picture-based Instruction Handbook is produced by the research team, the demonstration video is accessible via a YouTube link (https://youtu.be/F5OtK935Y8w). This is an information session (in week 0), no instructions on how to perform the exercise is given until one week after (in week 1), that is, the participants are required not to commence their Baduanjin mind-body exercise. After receiving the study information pack and resources, a Baduanjin mind-body exercise instructor (who is a member of the research team) will organise a Zoom meeting to meet with each participant to explain and demonstrate the eight movements and natural breathing methods that comprise the Baduanjin mind-body exercise program. Using the Zoom App, participants will be invited to watch the Baduanjin mind-body exercise demonstration videos which explains how to perform the exercise movements where the instructor will explain and demonstrate the eight movements and natural breathing methods with the participants. This is done before commencing the first exercise session in the program. In addition to self-guided practice, the participants will be asked to join in a coached Zoom exercise program with an instructor, either in the morning or afternoon or both sessions at their own choice throughout the intervention period (8 weeks). Participants will be requested to practice Baduanjin mind-body exercise at least 2 sessions per day, 6 days per week with each session lasting about 17-20 mins for 8 weeks. Missed sessions will not be considered as a protocol deviation. The Baduanjin mind-body exercise sessions via Zoom are instructed by members of the research team who have at least two years' experience in the practice of Baduanjin mind- body exercise. If participants miss out on any Zoom sessions, they can watch the demonstration video as a reference. Participants will be asked to record their daily Baduanjin mind-body exercise schedule in the Exercise Logbook. Recording this in Exercise Logbook will take approximately 2 minutes each session. This will happen twice daily, 6 times per week for 8 weeks. Weekly telephone calls will be performed by a research assistant to see how the participants are progressing and engaging with the Baduanjin mind-body exercise program. The weekly phone calls will also discuss any unexpected side effects or adverse events that might be related to the exercise. Finally, participants are asked to complete two (2) questionnaires at baseline (week 0) as part of the study intake process, and again at the end of week 4 and week 8 of the exercise program. These questionnaires are the brief fatigue inventory (BFI) and the PROMIS-29v2.0. The BFI measures fatigue. The PROMIS-29v2.0 is a patient reported outcome measure used by health services in NSW. Together, these will take 5-10 minutes to complete online and can be accessed using secure links that will be emailed to participants. There is also the Credibility and Expectancy Questionnaire (CEQ) which has four questions and takes one minute to complete. Two questions are completed before entry into the study (week 0), and two at the completion of the Baduanjin mind-body exercise program (week 9). One week after completing the Baduanjin mind-body exercise program (in week 9), a study team member will contact participants by phone for a final time. This is to check on the participant and see if there have any reports or adverse experiences. Participants will also be asked to complete for the final time the BFI and the PROMIS-29v2.0, along with the final two questions from the CEQ. This also includes two open questions for participants to provide feedback.

Sponsors

Western Sydney University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria are: (1) 18 years of age or older; (2) receiving adjuvant chemotherapy or completed adjuvant chemotherapy; (3) medical history of cancer diagnosis; (4) suffering from moderate CRF (rating of 4 to 6) as assessed by the BFI simple fatigue scale; (5) have a computer / device that is Wi-Fi or hotspot connected and be able to use smart phones, email, phone camera, (such as Facetime on iPhone), and Zoom conferencing app; (6) be aware of one’s cancer diagnosis; and (7) understand the intervention process and able to communicate and provide informed consent in English.

Exclusion criteria

The exclusion criteria are: (1) uncontrolled cardiopulmonary disease, angina, uncontrolled hypertension or uncontrolled postural hypotension; (2) uncontrolled nerve, muscle, or joint disease or injury affecting coordinated movement; (3) psychiatric illness or serious cognitive impairment and communication or language barriers that effect informed consent; (4) postoperative heart, cerebral vessel, or other serious complications; (5) those not fully recovered from breast surgery, axillary surgery, transabdominal rectus abdominus muscle reconstructive surgery or any other surgery that would preclude full participation in the program, (6) if an individual is otherwise not approved by their oncologist as being potentially eligible; (7) enrolled in other investigational studies which would impact cancer-related fatigue; and (8) a recent history (within previous 3 months) of regularly participating in Baduanjin mind-body exercise.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 7, 2026