Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults

NCT06225271 | Active Not Recruiting

• 1 other identifier: GSKY20230103
• Study Type: interventional
• Target: 934
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this cohort-based cluster-randomized controlled trial is to investigate the effect of the combined intervention of exercise, fruit, and vitamin supplementation on frailty among older adults. Older individuals aged 65\~80 years old with low physical activity levels and low fruit intake will be recruited. 14 clusters will be randomized into 2 arms with 1:1 ratio. Participants in the intervention arm will receive the combined intervention of physical activity, fruit, and vitamin supplementation 3 times a week for 2 months (the 1st and 6th months). They will also be given group interventions, such as self-management group activity or health education, at least once a week. Participants in the control arm will not receive any intervention.

Conditions

Frailty

Keywords

Older adults; Frailty; Exercise; Fruit; Vitamin supplementation; Cluster- randomized controlled trial; Muscle loss

Outcome Measures

Primary Outcomes (1)

• The change in handgrip strength at 12 months from baseline.

  Handgrip strength will be measured using a hand-held grip dynamometer. Participants will be asked to grip the dynamometer with left hand and right hand respectively while standing, maintaining their arm close to the body and straight down, exerting maximum force. This test will be conducted 3 times, and the values will be recorded in kilograms.

  Baseline and 12 months

Secondary Outcomes (13)

• The change in handgrip strength at 6 months from baseline.

  Baseline and 6 months

• The change in frailty index at 6 months and 12 months from baseline.

  Baseline, 6 months, and 12 months

• The change in the quantity and frequency of fruit intake at 12 months from baseline.

  Baseline and 12 months

• The change in physical activity volume and intensity at 12 months from baseline.

  Baseline and 12 months

• The incidence of a composite of all-cause death, cardiovascular and cerebrovascular diseases over 12 and 24 months.

  12 months, and 24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Behavioral: the combined intervention of exercise, fruit, and vitamin supplementation

Control group

NO INTERVENTION

Participants in the control arm will not receive any intervention.

Interventions

the combined intervention of exercise, fruit, and vitamin supplementation BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Permanent resident population aged 65\~80 years;
• Able to walk independently indoors and outdoors;
• Physical activity less than 1400 metabolic equivalent task (MET)-min/week and fruit intake less than 50 g/day；
• Have not taken vitamin B and vitamin C supplementation in the past 3 months.

You may not qualify if:

• Presence of a history of fracture;
• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead
• Suzhou Center for Disease Control and Prevention: collaborator

Study Sites (1)

Suzhou Center for Disease Control and Prevention

Suzhou, Jiangsu, China

Location

Related Publications (5)

• Haider S, Dorner TE, Luger E, Kapan A, Titze S, Lackinger C, Schindler KE. Impact of a Home-Based Physical and Nutritional Intervention Program Conducted by Lay-Volunteers on Handgrip Strength in Prefrail and Frail Older Adults: A Randomized Control Trial. PLoS One. 2017 Jan 13;12(1):e0169613. doi: 10.1371/journal.pone.0169613. eCollection 2017.

  PMID: 28085913 RESULT

• Kapan A, Winzer E, Haider S, Titze S, Schindler K, Lackinger C, Dorner TE. Impact of a lay-led home-based intervention programme on quality of life in community-dwelling pre-frail and frail older adults: a randomized controlled trial. BMC Geriatr. 2017 Jul 19;17(1):154. doi: 10.1186/s12877-017-0548-7.

  PMID: 28724351 RESULT

• Kim H, Suzuki T, Kim M, Kojima N, Ota N, Shimotoyodome A, Hase T, Hosoi E, Yoshida H. Effects of exercise and milk fat globule membrane (MFGM) supplementation on body composition, physical function, and hematological parameters in community-dwelling frail Japanese women: a randomized double blind, placebo-controlled, follow-up trial. PLoS One. 2015 Feb 6;10(2):e0116256. doi: 10.1371/journal.pone.0116256. eCollection 2015.

  PMID: 25659147 RESULT

• 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.

  PMID: 25659620 RESULT

• 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.

  PMID: 37997729 RESULT

MeSH Terms

Conditions

Frailty; Motor Activity; Muscular Atrophy

Interventions

Fruit

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 25, 2024
• Study Start: March 8, 2024
• Primary Completion: April 15, 2025
• Study Completion: March 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-09

Locations

CN (1)