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

N/AActive Not RecruitingNCT06225271

Nanjing Medical University934 enrolled

Overview

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.

Objectives Primary objectives • 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.

Interventions

the combined intervention of exercise, fruit, and vitamin supplementationBEHAVIORAL

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

Sex: ALLMin age: 65 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Permanent resident population aged 65\~80 years; 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: 1. Presence of a history of fracture; 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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 months

Secondary Outcomes

The change in handgrip strength at 6 months from baseline.

Time frame: Baseline and 6 months

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

Outcome is defined as the change in the score of modifiable variables in the frailty index from baseline. The frailty index consisted 28 variables covering age, physical measurement, sleep quality, history of surgery, fall, and fracture, history of the disease, oral hygiene, respiratory function, and physical function self-assessment aspects. 24 of the 28 variables can be changed. The frailty index is a continuous variable that ranged from 0 to 33, with a higher value indicating a worse, frailer status.

Time frame: Baseline, 6 months, and 12 months

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

Fruit intake will be collected by questionnaire for the frequency of consumption and weights per intake. The frequency will be determined by filling in the number of times the participants eat fruit per week/day/monthly/year. Fruit quantity is determined by the product of frequency and weights of a single fruit intake.

Time frame: Baseline and 12 months

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

Information on physical activity levels during the past week will be collected through the International Physical Activity Questionnaire Scale-Short Form (IPAQ-SF). The IPAQ-SF captures four levels of physical activity intensity: vigorous-intensity physical activity, moderate-intensity physical activity, walking time, and average sitting time on weekdays, including sedentary work. Physical activity volume will be determined by summing the metabolic equivalent task (MET)-min/week values for walking, moderate physical activity, and vigorous physical activity. Higher values represent higher levels of physical activity, with a minimum value of 0.

Time frame: Baseline and 12 months

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

Time frame: 12 months, and 24 months

The incidence of all-cause death over 12 and 24 months.

Time frame: 12 months, and 24 months

The incidence of cardiovascular and cerebrovascular diseases over 12 and 24 months.

Time frame: 12 months, and 24 months

The change in low-density lipoprotein cholesterol (LDL-C) at 12 months and 24 months from baseline.