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
30 июня 2026 г. обновлено: Hong Kong Baptist University
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
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.
Обзор исследования
Статус
Рекрутинг
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
48
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Yanping Duan
- Номер телефона: 34115638
- Электронная почта: duanyp@hkbu.edu.hk
Учебное резервное копирование контактов
- Имя: Yanping Duan
Места учебы
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Kwun Tong, Гонконг
- Рекрутинг
- Bliss District Elderly Community Centre
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Контакт:
- LAM Hon Wai
- Номер телефона: 2717 0822
- Электронная почта: boplus@hkcs.org
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- community-dwelling older adults aged 65 to 84 years, who are youngest-old and middle-old with relatively stable health status compared with oldest-old aged 85 years and above
- Scoring 5-15 using the Chinese version of Geriatric Depression Scale.
- Access the smartphone and internet through which the Hospital Authority (HA) HA Go mobile app.
- Pass the PAR-Q screening and no contraindications for physical exercise.
- No history of smoking.
Exclusion Criteria:
- suffer from cognitive impairment identified by the Chinese version of the Mini-Mental Status Examination (i.e., score < 24).
- regularly consume tea or coffee (≥3 times/day, last for ≥6 months) as these habitual behaviors can contaminate the effects of tea consumption intervention per se.
- Individuals with contraindications for tea consumption, such as insomnia, anemia, neurasthenia, hyperthyroidism, digestive ulcers, etc.
- The concurrent use of sedative and tranquilizer medications, such as benzodiazepines and barbiturates.
- take warfarin;
- Participants are attending other health projects related to physical exercise and diet.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: blended Baduanjin and Green Tea consumption program
Participants, will receive the 12-week blended Baduanjin (60 mins/session) and Green Tea consumption (2 cups per day for 5 weeks) program
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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.
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Плацебо Компаратор: Non-treatment control
Participants will receive biweekly telephone calls within 12 weeks.Each call will last about 5 minutes.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Self-reported depressive symptoms
Временное ограничение: 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).
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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).
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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).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gut-microbiota
Временное ограничение: 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.
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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.
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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.
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Perceived quality of life
Временное ограничение: 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)
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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.
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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)
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Retention rate
Временное ограничение: 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).
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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.
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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).
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Session attendance rate
Временное ограничение: Session attendance will be recorded during the 12-week intervention
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Participants completed at least 83% of intervention sessions for BDJ (20 out of 24 sessions) and GT consumption (140 out of 168 cups)
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Session attendance will be recorded during the 12-week intervention
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Yanping Duan, Hong Kong Baptist University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Kelly JR, Borre Y, O' Brien C, Patterson E, El Aidy S, Deane J, Kennedy PJ, Beers S, Scott K, Moloney G, Hoban AE, Scott L, Fitzgerald P, Ross P, Stanton C, Clarke G, Cryan JF, Dinan TG. Transferring the blues: Depression-associated gut microbiota induces neurobehavioural changes in the rat. J Psychiatr Res. 2016 Nov;82:109-18. doi: 10.1016/j.jpsychires.2016.07.019. Epub 2016 Jul 25.
- Luo X, Zhao M, Zhang Y, Zhang Y. Effects of baduanjin exercise on blood glucose, depression and anxiety among patients with type II diabetes and emotional disorders: A meta-analysis. Complement Ther Clin Pract. 2023 Feb;50:101702. doi: 10.1016/j.ctcp.2022.101702. Epub 2022 Nov 8.
- Zhao CN, Tang GY, Cao SY, Xu XY, Gan RY, Liu Q, Mao QQ, Shang A, Li HB. Phenolic Profiles and Antioxidant Activities of 30 Tea Infusions from Green, Black, Oolong, White, Yellow and Dark Teas. Antioxidants (Basel). 2019 Jul 10;8(7):215. doi: 10.3390/antiox8070215.
- Wan Z, Qin X, Tian Y, Ouyang F, Wang G, Wan Q. Long-Term Consumption of Green Tea Can Reduce the Degree of Depression in Postmenopausal Women by Increasing Estradiol. Nutrients. 2023 Oct 25;15(21):4514. doi: 10.3390/nu15214514.
- Souza PB, de Araujo Borba L, Castro de Jesus L, Valverde AP, Gil-Mohapel J, Rodrigues ALS. Major Depressive Disorder and Gut Microbiota: Role of Physical Exercise. Int J Mol Sci. 2023 Nov 28;24(23):16870. doi: 10.3390/ijms242316870.
- Pan CW, Ma Q, Sun HP, Xu Y, Luo N, Wang P. Tea Consumption and Health-Related Quality of Life in Older Adults. J Nutr Health Aging. 2017;21(5):480-486. doi: 10.1007/s12603-016-0784-0.
- Leung, K., Tay, M., Cheng, S., & Lin, F. (1997). Hong Kong Chinese version World Health Organization Quality of Life Measure-Abbreviated Version WHOQoL-BREF (HK). Hong Kong: Hong Kong Hospital Authority.
- Jin Y, Sun HL, Lam SC, Su Z, Hall BJ, Cheung T, Qin MZ, Ng CH, Xiang YT; International Research Collaboration on COVID-19. Depressive symptoms and gender differences in older adults in Hong Kong during the COVID-19 pandemic: a network analysis approach. Int J Biol Sci. 2022 Jun 6;18(10):3934-3941. doi: 10.7150/ijbs.69460. eCollection 2022.
- Jin X, Yang S, Lu J, Li Y, Zhao Y, Li D, Wang X, Liu L, Wu M. Exploring the therapeutic mechanism of Baduanjin in the treatment of elderly stable angina pectoris based on the gut microbiota-lipid metabolism spectrum: Study protocol for a randomized controlled trial. Front Public Health. 2022 Oct 31;10:1027839. doi: 10.3389/fpubh.2022.1027839. eCollection 2022.
- Jia W, Tang Q, Zou Y, Yang Y, Wu W, Xu W. Investigating the antidepressant effect of Ziyan green tea on chronic unpredictable mild stress mice through fecal metabolomics. Front Microbiol. 2023 Aug 24;14:1256142. doi: 10.3389/fmicb.2023.1256142. eCollection 2023.
- Huang Y, Li L, Gan Y, Wang C, Jiang H, Cao S, Lu Z. Sedentary behaviors and risk of depression: a meta-analysis of prospective studies. Transl Psychiatry. 2020 Jan 22;10(1):26. doi: 10.1038/s41398-020-0715-z.
- Hu L, Ni Z, Zhao K, Li X, Gao X, Kang Y, Yu Z, Qin Y, Zhao J, Peng W, Lu L, Sun H. The association between oral and gut microbiota in male patients with alcohol dependence. Front Microbiol. 2023 Jul 28;14:1203678. doi: 10.3389/fmicb.2023.1203678. eCollection 2023.
- Lopez-Torres Hidalgo J; DEP-EXERCISE Group. Effectiveness of physical exercise in the treatment of depression in older adults as an alternative to antidepressant drugs in primary care. BMC Psychiatry. 2019 Jan 14;19(1):21. doi: 10.1186/s12888-018-1982-6.
- Dou, W., Su, S., Zhao, Y., Guo, X., Zhang, Z., Yao, J., & Wang, S. (2020). Effect of Baduanjin on the balancing ability and intestinal flora for older adults. China Preventive Medicine Journal, 32(4), 425-428.
- Cheung DST, Chau PH, Lam TC, Ng AYM, Kwok TWH, Takemura N, Woo J, Yu DS, Lin CC. A pilot randomized controlled trial using Baduanjin qigong to reverse frailty status among post-treatment older cancer survivors. J Geriatr Oncol. 2022 Jun;13(5):682-690. doi: 10.1016/j.jgo.2022.02.014. Epub 2022 Mar 7.
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- Manshadi Seyed Ali D, Seyed Alireza M, Mohammad Reza S, Jayran Z, SeyedAhmad S, Shams Ali R, Seyed Saeid M, Ali AA. Effect of green tea consumption in treatment of mild to moderate depression in Iranian patients living with HIV: A double-blind randomized clinical trial. Chin Herb Med. 2020 Nov 26;13(1):136-141. doi: 10.1016/j.chmed.2020.08.002. eCollection 2021 Jan.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 ноября 2025 г.
Первичное завершение (Оцененный)
28 ноября 2026 г.
Завершение исследования (Оцененный)
30 апреля 2027 г.
Даты регистрации исследования
Первый отправленный
30 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
30 июня 2026 г.
Первый опубликованный (Действительный)
7 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
7 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
30 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RC- FNRA-IG /24-25/RC- FNRA-IG
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .