Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults: A Cohort-based Cluster- Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- Nanjing Medical University
- Enrollment
- 934
- Locations
- 1
- Primary Endpoint
- The change in handgrip strength at 12 months from baseline.
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
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.
Detailed Description
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.
Investigators
Chong Shen
Professor
Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The change in handgrip strength at 12 months from baseline.
Time Frame: Baseline and 12 months
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.
Secondary Outcomes
- The incidence of cardiovascular and cerebrovascular diseases over 12 and 24 months.(12 months, and 24 months)
- The change in low-density lipoprotein cholesterol (LDL-C) at 12 months and 24 months from baseline.(Baseline, 12 months, and 24 months)
- The change in handgrip strength at 6 months from baseline.(Baseline and 6 months)
- The incidence of a composite of all-cause death, cardiovascular and cerebrovascular diseases over 12 and 24 months.(12 months, and 24 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 change in high density lipoprotein cholesterol (HDL-C) at 12 months and 24 months from baseline.(Baseline, 12 months, and 24 months)
- The change in frailty index at 6 months and 12 months from baseline.(Baseline, 6 months, and 12 months)
- Incremental cost-effectiveness ratio (ICER)(Baseline and 12 months)
- The incidence of all-cause death over 12 and 24 months.(12 months, and 24 months)
- The change in total cholesterol (TC) at 12 months and 24 months from baseline.(Baseline, 12 months, and 24 months)
- The change in triglycerides (TG) at 12 months and 24 months from baseline.(Baseline, 12 months, and 24 months)
- The change in fasting blood glucose at 12 months and 24 months from baseline.(Baseline, 12 months, and 24 months)