Bliss District Elderly Community Centre
Kwun Tong, Hong Kong
Location status: Recruiting
NCT Number: NCT07687940
Depression is a common mental health issue in older adults, often manifesting as insomnia, low mood, vague somatic complaints, cognitive decline, and recurrent thoughts of death or suicide. Even subthreshold depressive symptoms in late life significantly impair quality of life. In Hong Kong, recent data show high prevalence of depressive symptoms among community-dwelling older adults (43.7% in men, 54.8% in women), underscoring the urgent public health and economic need for effective interventions.
Although the previous evidence has shown that BDJ and GT consumption can improve depressive symptoms, gut microbiota, and QoL respectively, the feasibility and effect of the combination of two intervention approaches in older adults remain unclear. Therefore, the proposed study aims to (1) determine the feasibility of a 12-week blended BDJ and GT consumption program among Hong Kong community-dwelling older adults with depressive symptoms in a small-scale sample, and (2) examine the effects of the blended BDJ and GT consumption program on their depressive symptoms, gut-microbiota and QoL compared with that in the active control group.
Interested in participating?
Request Info65 year–84 year
All sexes
Interventional
Not applicable
Kwun Tong, Hong Kong
Location status: Recruiting
This study will be a single-blind 2-group RCT to examine the feasibility and the effects (immediate effects and 3-month residual effects) of the 12-week blended BDJ and GT consumption program on depressive symptoms, gut-microbiota and QoL among older adults with depressive symptoms. The target population will be Hong Kong community-dwelling older adults with depressive symptoms. Participants will be randomly assigned into one of two groups: a blended BDJ and GT consumption group and a control group. Evaluation will be conducted at pre-intervention (T1), post-intervention (T2), and 3-month after intervention completion (T3). Outcome assessors will be blinded from the assignment results to the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants will be invited to attend both BDJ exercise and GT consumption interventions for 12 weeks. The exercise instructor will provide group teaching with individual instructions on specific movements. Participants will also adopt a dose of 3g tea with 200ml water, 2 cups daily. The tea consumption will last 12 weeks in this project to keep the same intervention duration as BDJ group.
Participants will receive biweekly telephone calls within 12 weeks.Each call will last about 5 minutes.The participants will be asked several questions about their physical exercise and tea consumption behaviors.
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 12-weeks intervention (T2 post-intervention), and 3 months after intervention completion (T3 follow-up test).
The Chinese version of the 15-item Geriatric Depression Scale (GDS-C) will be used to measure the subjective depression level. The GDS are the most widely used scales for the detection of depression symptoms in older adults (Cronbach's α = .81 -.83).
Time frame: Evaluations of stool test will be performed three times at pre-intervention (T1), the 12-week (3-month) post-intervention (T2), and the 3-month follow-up (T3) occasions.
Total genomic DNA will be extracted from stool samples using NEBnext microbiome DNA enrichment kit (New England Biolabs, Ipswich, MA, US) following the manufacturer's instructions. Gut microbiome will be an be analysed by 16S rRNA gene amplicon sequencing for the V3-V4 region (OmicLab Limited, Hong Kong). The amplified products will be sequenced on the Illumina NovaSeq platform and analysed using QIIME1 software. Several microbiome compositional and functional indicators will be measured, e.g., total gene counts, relative abundance of predominant bacterial groups, alpha and beta diversity, and functional annotations of the gut microbiota (Hu et al., 2023; Wang et al., 2023). DNA extraction, 16S rRNA sequencing and analyses will be performed by OmicLab Limited, Hong Kong.
Time frame: Outcome evaluations will be performed three times at pre-intervention (T1 baseline), after 12-week intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test)
The quality of life will be assessed using the brief version of the Hong Kong Chinese WHO Quality of Life Scale (WHOQOL-BREF) (Cronbach's α = .73 - .84). The scale includes 28 items, covering four dimensions of how older adults perceive their quality of life. The total score of the questionnaire ranges from 28 to 140, and a higher score indicates that the individual feels they have a high quality of life.
Time frame: Data collection will be performed three times at pre-intervention (T1 baseline), after 12-week intervention (T2 post-test), and 3 months after intervention completion (T3 follow-up test).
Percentage of participants completing assessments at the pre-intervention test, post-intervention test, and follow-up test. Criterion: at least 75% of participants completed data collection.
Time frame: Session attendance will be recorded during the 12-week intervention
Participants completed at least 83% of intervention sessions for BDJ (20 out of 24 sessions) and GT consumption (140 out of 168 cups)
Contact information is provided by the study sponsor or research team.
Hong Kong Baptist University
Other
Feasibility and Effects of a Blended Baduanjin Exercise and Green Tea Consumption Program on Depressive Symptoms, Gut Microbiota and Quality of Life in Older Adults: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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