Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults
NCT ID: NCT06225271
Last Updated: 2025-12-19
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
934 participants
INTERVENTIONAL
2024-03-08
2026-03-01
Brief Summary
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Detailed Description
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• To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on preventing muscle loss among older adults over the 12-month period.
Secondary objectives
* To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on preventing muscle loss in older adults over 6 months.
* To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on ameliorating frailty in older adults over 6 and 12 months.
* To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on improving healthy behavior of physical activity and fruit intake in older adults over 12 months.
* To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on lower the risk of all-cause hospitalization in the older adults over 12 months.
* To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on lower the risk of all-cause death, cardiovascular and cerebrovascular disease in the older adults over 12 and 24 months.
* To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on regulating blood lipids in the older adults over 12 and 24 months.
* To evaluate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on regulating blood glucose in the older adults over 12 and 24 months.
* To evaluate the health economic effectiveness of the combined intervention of exercise, fruit, and vitamin supplementation.
Sample size
Sample size was estimated using the Power Analysis and Sample Size (PASS) software (version 15.0.5) based on data from published research. Previous studies showed that the Cohens' d value was between 0.18\~1.78. With these data, we estimated effect size of Cohen' d = 0.45, considering probabilities of 5% for type I error, 20% for type II error, and 0.05 for intraclass correlation coefficient (ICC). We randomized all 14 clusters (villages) into two arms with 1:1 ratio, and the total sample size was calculated to be 700 (50 participates per cluster). A conservative estimate of 25% loss to follow-up or drop-out indicates a total of 934 participates is needed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
Participants in the intervention group will receive group intervention and individual intervention. Group interventions will include participants' communication meeting and other approach, such as self-management group. They will also receive the combined intervention of physical activity, fruit, and vitamin supplementation 3 times a week for 2 months (the 1st and 6th months).
the combined intervention of exercise, fruit, and vitamin supplementation
Group intervention
After each intervention, investigators will hold a 15-minute communication and discussion session for the participants. Besides, community health workers will organize at least one health education activity per week during the intervention for no less than 45 minutes.
Individual intervention
Physical activity
The participants will be gathered at the community activity center or day care center. The participants will be allowed to exercise in a way that interests them. The duration of exercise should be longer than 30 minutes.
Fruit supplementation
Consideration of seasonal supply situation and the participants' diabetic status, various types of fruit will be prepared. The fruit will be divided into 50g/100g servings. Participants will be required to eat on site.
Vitamin supplementation
During the intervention, the participants will be required to take 1 tablet of vitamin B complex plus 1 tablet of vitamin C every day.
Control group
Participants in the control arm will not receive any intervention.
No interventions assigned to this group
Interventions
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the combined intervention of exercise, fruit, and vitamin supplementation
Group intervention
After each intervention, investigators will hold a 15-minute communication and discussion session for the participants. Besides, community health workers will organize at least one health education activity per week during the intervention for no less than 45 minutes.
Individual intervention
Physical activity
The participants will be gathered at the community activity center or day care center. The participants will be allowed to exercise in a way that interests them. The duration of exercise should be longer than 30 minutes.
Fruit supplementation
Consideration of seasonal supply situation and the participants' diabetic status, various types of fruit will be prepared. The fruit will be divided into 50g/100g servings. Participants will be required to eat on site.
Vitamin supplementation
During the intervention, the participants will be required to take 1 tablet of vitamin B complex plus 1 tablet of vitamin C every day.
Eligibility Criteria
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Inclusion Criteria
2. Able to walk independently indoors and outdoors;
3. Physical activity less than 1400 metabolic equivalent task (MET)-min/week and fruit intake less than 50 g/day；
4. Have not taken vitamin B and vitamin C supplementation in the past 3 months.
Exclusion Criteria
2. Patients with severe impairment of renal or hepatic fuction. Severe hepatic impairment is defined as serum alanine aminotransferase and aspartate aminotransferase levels above 100 U/L, while severe renal impairment is defined as estimated glomerular filtration rate (eGFR) \< 45 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations.
65 Years
80 Years
ALL
Yes
Sponsors
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Suzhou Center for Disease Control and Prevention
UNKNOWN
Nanjing Medical University
OTHER
Responsible Party
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Chong Shen
Professor
Locations
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Suzhou Center for Disease Control and Prevention
Suzhou, Jiangsu, China
Countries
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References
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Scheinin TM. [Rupture of the left main bronchus and pulmonary artery caused by subcutaneous thoracic injuries]. Thoraxchir Vask Chir (1962). 1966 Feb;14(1):54-6. doi: 10.1055/s-0028-1100774. No abstract available. German.
Gomes GS. [Sauna]. Rev Bras Med. 1970 Jan;27(1):47-9. No abstract available. Portuguese.
Inaba Y, Tanaka Y, Ishii S, Morimoto T, Sato K. Ibaraki virus, an agent of epizootic disease of cattle resembling bluetongue. IV. Physicochemical and serological properties of the virus. Jpn J Microbiol. 1970 Sep;14(5):351-60. doi: 10.1111/j.1348-0421.1970.tb00535.x. No abstract available.
Kwon J, Yoshida Y, Yoshida H, Kim H, Suzuki T, Lee Y. Effects of a combined physical training and nutrition intervention on physical performance and health-related quality of life in prefrail older women living in the community: a randomized controlled trial. J Am Med Dir Assoc. 2015 Mar;16(3):263.e1-8. doi: 10.1016/j.jamda.2014.12.005. Epub 2015 Feb 3.
Chen B, Li M, Zhao H, Liao R, Lu J, Tu J, Zou Y, Teng X, Huang Y, Liu J, Huang P, Wu J. Effect of Multicomponent Intervention on Functional Decline in Chinese Older Adults: A Multicenter Randomized Clinical Trial. J Nutr Health Aging. 2023;27(11):1063-1075. doi: 10.1007/s12603-023-2031-9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GSKY20230103
Identifier Type: -
Identifier Source: org_study_id