The benefits of Baduanjin on the risk of falls and balance in the elderly
| ISRCTN | ISRCTN15457910 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15457910 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | USM/JEPeM/22080521 |
| Sponsor | Universiti Sains Malaysia |
| Funder | Investigator initiated and funded |
- Submission date
- 01/07/2024
- Registration date
- 17/07/2024
- Last edited
- 10/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Physical function declines in older adults as they age, and failure to detect incorrect body postures or restore balance increases the likelihood of falls. Therefore, improving the balance function of the elderly has become an important goal in geriatric rehabilitation. Baduanjin is one of the traditional Chinese qigong treatment methods. Compared with other forms of exercise, it focuses more on the integration of body and mind and improves the physical function of the elderly and various clinical populations. However, previous studies on Baduanjin have only used subjective scales that indirectly assess fall risk. The effects of Baduanjin on gait biomechanics and balance in older adults are unknown. Therefore, this study evaluated the impact of 12 weeks of Baduanjin on the risk of falls from all aspects, including balance, isometric knee joint strength, and gait parameters.
Who can participate?
People aged 60-75 years who have normal cognitive ability and cognitive impairment
What does the study involve?
Before the intervention, participants were screened for their health status and randomly divided into the Baduanjin group or the control group. Participants are instructed not to reveal their group allocation to the assessor. Before the first week of intervention, the research team spent a week demonstrating and teaching the correct movements, warm-up and stretching skills of these exercises to the participants. The mid-intervention assessment is performed after the sixth week of intervention. While the post-intervention assessment was performed at the completion of the intervention (week 13th). Similar assessments are performed during pre-, mid- and post-intervention.
What are the possible benefits and risks of participating?
Participants can increase balance and reduce the risk of falls by participating in this study and getting their own exercise prescription. The risk mainly includes delayed muscle soreness after exercise. Researchers will protect the safety of the whole sports meeting.
Where is the study run from?
Shanxi Normal University (Malaysia)
When is the study starting and how long is it expected to run for?
February 2023 to February 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Shihao Xie, usmxieshihao1995@163.com
Contact information
Public, Scientific, Principal investigator
Universiti Sains Malaysia Kampus Kesihatan
Kubang Kerian
Kelantan
Kota Bharu
16150
Malaysia
| Phone | +86 (0)16651738983 |
|---|---|
| usmxieshihao1995@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of 12-Week Baduanjin intervention on the balance, lower limb strength and risks of falls among elderly people |
| Study objectives | 1. HO: After 12 weeks of intervention, the Baduanjin group had no significant effect on the balance among elderly people. Ha: After 12 weeks of intervention, the Baduanjin group had a significant effect on balance among elderly people. 2. HO: After 12 weeks of intervention, the Baduanjin group had no significant effect on leg strength among elderly people. Ha: After 12 weeks of intervention, the Baduanjin group had a significant effect on leg strength among elderly people. 3. HO: After 12 weeks of intervention, the Baduanjin group had no significant effect on gait biomechanics among elderly people. Ha: After 12 weeks of intervention, the Baduanjin group had a significant effect on the gait biomechanics among elderly people. 4. HO: After 12 weeks of intervention, the Baduanjin group had no significant effect on gait stability among elderly people. Ha: After 12 weeks of intervention, the Baduanjin group had a significant effect on gait stability among elderly people. |
| Ethics approval(s) |
Approved 02/02/2023, Universiti Sains Malaysia Human Research Ethics Committee (Universiti Sains Malaysia Kampus Kesihatan, Kubang Kerian, Kelantan, Kota Bharu, 16150, Malaysia; +60 (0)9 767 2351; jepem@usm.my), ref: USM/JEPeM/22080521 |
| Health condition(s) or problem(s) studied | Balance, lower limb strength and risks of falls among elderly people |
| Intervention | The participants are divided into groups by drawing lots through the blind box with two kinds of paper strips: B and C. The number of two kinds of paper strips is equal, and male participants first drew lots. After the allocation is completed, female participants then drew lots to ensure that the gender ratios of the two groups are consistent. They were randomly divided into two groups. The Baduanjin group received a 12-week Baduanjin exercise intervention, exercising three times a week. The control group underwent walking exercises of equal intensity. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Risk of falls assessed using the Morse Fall Scale at baseline, week 6, and week 13 |
| Key secondary outcome measure(s) |
1. Balance function assessed using a single leg standing test at baseline, week 6 and week 13 |
| Completion date | 01/02/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 46 |
| Total final enrolment | 46 |
| Key inclusion criteria | 1. Male or female 2. Aged 60-75 years 3. Have normal cognitive ability and cognitive impairment as indicated by Mini-mental State Examination (MMSE) of <21 4. Not participating in other exercise intervention |
| Key exclusion criteria | 1. Have any diseases associated with the nervous system 2. Have diabetes, cardiovascular diseases, peripheral vascular diseases, implanted electrical devices, non-ambulatory status and presence of systemic inflammatory arthritis 3. Have vestibular dysfunction |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Xiaodian District
Taiyuan
030031
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2024: Study's existence confirmed by the Universiti Sains Malaysia Human Research Ethics Committee.
