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

Nanjing Medical University

Status: Not yet enrolling

Conditions: Frailty

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06225271

GSKY20230103

Details and patient eligibility

About

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.

Full 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 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.

Statistical analysis

Categorical variables are presented as frequencies (n) and percentages (%). Continuous data is reported as means and standard deviation (SD) or medians (interquartile range) for non-normality of distribution.

The primary analysis will compare the change in handgrip strength at 12 months from baseline between the intervention and control groups using the cluster-adjusted generalized linear mixed model (GLMM). The primary analyses will be intention-to-treat.

Secondary analyses:

1. Compare the change in handgrip strength at 6 months from baseline between the intervention and control groups using the cluster-adjusted GLMM.
2. Compare the change in frailty scale at 6 months and 12 months from baseline between the control and intervention groups using the cluster-adjusted GLMM.
3. Compare the change in physical activity volume and intensity and fruit intake and frequency at 12 months from baseline. This will be achieved by comparing the least square mean between groups.
4. Compared the incidence of a composite of all-cause death, cardiovascular and cerebrovascular diseases using Poisson regression model.
5. Compare the incidence of all-cause death using Poisson regression model.
6. Compare the incidence of cardiovascular and cerebrovascular using Poisson regression model.
7. Compared the change in lipid indicators at 12 months and 24 months from baseline between the intervention and control groups using the cluster-adjusted GLMM.
8. Compared the change in glucose indicators at 12 months and 24 months from baseline between the intervention and control groups using the cluster-adjusted GLMM.
9. Incremental cost-effectiveness ratio (ICER). The outcome defined as the excess cost of a strategy over the cost of the baseline strategy divided by the incremental difference in effectiveness between the strategy in question and the baseline strategy.

Enrollment: 934 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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934 participants in 2 patient groups

Intervention group

Experimental group

Description:

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).

Treatment:

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

Control group

No Intervention group

Description:

Participants in the control arm will not receive any intervention.