Survey and intervention study on the health status of older adults
| ISRCTN | ISRCTN17889491 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17889491 |
| Secondary identifying numbers | National Social Science Fund of China Grant No. 23FTYB003 |
- Submission date
- 27/04/2025
- Registration date
- 21/05/2025
- Last edited
- 28/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Subthreshold depression (StD) affects approximately 18.6% of older adults worldwide. There is a paucity of evidence to guide the management of StD in older adults. Baduanjin, a traditional Chinese mind-body exercise, shows promise in addressing this gap in this population. However, the research on its efficacy and underlying mechanisms remains unclear. This study aims to evaluate the effects of Baduanjin exercise on depressive symptoms and StD related symptoms, and to explore the antidepressant mechanisms through a multidimensional assessment of older individuals with StD.
Who can participate?
Older adults aged 60 to 80 years old with StD from six communities
What does the study involve?
This study will randomly assign participants to either a Baduanjin intervention group or a control group for 12 weeks. Primary outcomes (depressive symptoms) and secondary outcomes (anxiety, sleep quality, frailty, biochemical parameters, autonomic nervous function, and brain function) will be assessed at baseline, post-intervention and one-month follow-up. Intention-to-treat analyses will be conducted for all collected data using linear mixed-effects models.
What are the possible benefits and risks of participating?
The present study intends to provide valuable insights into the efficacy of Baduanjin exercise in ameliorating depressive symptoms and StD-related symptoms in older adults with StD. Moreover, this study also seeks to investigate the antidepressant mechanisms of Baduanjin exercise through multimodal neurophysiological assessments. The findings of this study will advance understanding of Baduanjin exercise as a potential non-pharmacological intervention for the management of StD and prevent its progression to major depressive disorder in aging populations.
This is a low-risk interventional study involving no sensitive data or harmful interventions. Therefore, no significant risks are anticipated.
Where is the study run from?
Shandong University, China
When is the study starting and how long is it expected to run for?
August 2022 to July 2026
Who is funding the study?
The National Social Science Fund of China, China
Who is the main contact?
Mingqi Wang, e-mail: wangmingqi 0606@163.com
Contact information
Scientific, Principal Investigator
17922 Jingshi Road
Jinan, Shandong
250061
China
| Phone | +8617658591347 |
|---|---|
| wangmingqi0606@163.com |
Public
17922 Jingshi Road
Jinan, Shandong
250061
China
| Phone | +8617724023477 |
|---|---|
| 2665136377@qq.com |
Study information
| Study design | Single-blind cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community, Laboratory |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Survey and intervention study on the health status of older adults |
| Study objectives | We hypothesize that Baduanjin exercise intervention may significantly reduce depressive symptoms among older adults with subthreshold depression. |
| Ethics approval(s) |
Approved 06/08/2022, Ethics Committee of Public Health in Shandong University (44 West Wenhua Road, Ji'nan, Shandong, 250012, China; +86 531 8838 2091; sunshuai@sdu.edu.cn), ref: LL20220801 |
| Health condition(s) or problem(s) studied | Older adults with subthreshold depression |
| Intervention | This cluster-randomized controlled trial will enroll a total of 92 older adults with subthreshold depression from six communities, who will be randomly assigned to (1:1 ratio) either a Baduanjin intervention group (three supervised 60-minute sessions/week) or a control group (will not receive any training) for 12 weeks. Randomization: After completing baseline evaluations, the six communities will be randomly assigned to either the Baduanjin exercise group or the control group in a 1:1 allocation ratio. The allocation sequence, generated via the Sealed Envelope website (www.sealedenvelope.com), will be concealed using sequentially numbered and opaque envelopes by an independent researcher with no involvement in participant recruitment, intervention, and outcome assessment. The envelopes will be opened sequentially only after each community has completed participant recruitment and passed baseline data verification. Baduanjin intervention: Participants assigned to the Baduanjin group will engage in a 12-week, supervised group-based Baduanjin exercise program. The standardized protocol comprises three 60-minute in-person sessions per week in a community-based setting. This protocol will be in accordance with the Fitness Qigong: Baduanjin guidelines (General Administration of Sport of China, 2003). Each session will comprise 15 minutes of preparatory exercises (warm-up), 40 minutes of Baduanjin practice, and 5 minutes of post-exercise muscle relaxation. |
| Intervention type | Behavioural |
| Primary outcome measure | Depressive symptoms measured using the 10-item Center for Epidemiologic Studies Depression Scale at baseline, post-intervention and one-month follow-up |
| Secondary outcome measures | The following secondary outcome measures will be assessed at baseline, post-intervention and one-month follow-up: 1. Cognitive performance will be measured using the Stroop test 2. Anxiety symptoms will be measured using the 7-item Generalized Anxiety Disorder scale 3. Physical frailty will be measured using the Fried frailty phenotype 4. Sleep quality will be measured using the Pittsburgh Sleep Quality Index 5. Heart rate variability will be measured using a physiological monitoring system (DHD-6000, DonghuaYuan Medical Co., Ltd., China) 6. Biochemical parameters will be measured using commercial ELISA kits 7. Gut microbiome will be measured using 16S rRNA gene amplification 8. Magnetic resonance imaging will be collected using a 3.0-T GE MR750 scanner |
| Overall study start date | 06/08/2022 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Resident |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 92 |
| Key inclusion criteria | 1. Age >=60 years 2. Clinically relevant depressive symptoms (Geriatric Depression Scale-15 [GDS-15] score >=5) 3. No regular physical exercise within the past year (regular exercise defined as 3–4 sessions/week, 30 minutes/session, sustained for >=3 months) 4. Provided informed consent |
| Key exclusion criteria | 1. History of depression, bipolar disorder or other psychiatric disorders 2. Contraindications to exercise (e.g., cardiovascular or cerebrovascular diseases, musculoskeletal disorders, neurological disorders) 3. Severe cognitive impairment, MMSE score <=24 4. Current receiving structured psychotherapeutic interventions 5. Contraindications to MRI (e.g., claustrophobia, implanted metal devices such as cardiac pacemakers, cochlear implants, artificial heart valves; if MRI was used) |
| Date of first enrolment | 31/05/2025 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Jinan, Shandong
250061
China
Sponsor information
University/education
17922 Jingshi Road
Jinan Shandong
250012
China
| Phone | +86 0531-88395114 |
|---|---|
| sunguoxiao@sdu.edu.cn | |
| Website | https://www.sdu.edu.cn |
"ROR" |
https://ror.org/0207yh398 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Chinese National Funding of Social Sciences, 国家社会科学基金, National Social Science Foundation of China, National Social Science Foundation, NSSFC
- Location
- China
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mingqi Wang, wangmingqi 0606@163.com on publication of the paper. |
Editorial Notes
28/04/2025: Study's existence confirmed by the Shandong University School of Public Health Ethics Committee.
