Clinical trial NCT06225271: Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults
Official title: Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults: A Cohort-based Cluster- Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Keywords: Older adults
Frailty
Exercise
Fruit
Vitamin supplementation
Cluster- randomized controlled trial
Muscle loss
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Suzhou Center for Disease Control and Prevention
First posted: 2024-01-25
Enrollment: 934
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in handgrip strength at 12 months from baseline.
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: The change in handgrip strength at 6 months from baseline.
timeFrame: Baseline and 6 months
measure: The change in frailty index at 6 months and 12 months from baseline.
timeFrame: Baseline, 6 months, and 12 months
measure: The change in the quantity and frequency of fruit intake at 12 months from baseline.
timeFrame: Baseline and 12 months
measure: The change in physical activity volume and intensity at 12 months from baseline.
timeFrame: Baseline and 12 months
measure: The incidence of a composite of all-cause death, cardiovascular and cerebrovascular diseases over 12 and 24 months.
timeFrame: 12 months, and 24 months
measure: The incidence of all-cause death over 12 and 24 months.
timeFrame: 12 months, and 24 months
measure: The incidence of cardiovascular and cerebrovascular diseases over 12 and 24 months.
timeFrame: 12 months, and 24 months
measure: The change in low-density lipoprotein cholesterol (LDL-C) at 12 months and 24 months from baseline.
timeFrame: Baseline, 12 months, and 24 months
measure: The change in high density lipoprotein cholesterol (HDL-C) at 12 months and 24 months from baseline.
timeFrame: Baseline, 12 months, and 24 months
measure: The change in total cholesterol (TC) at 12 months and 24 months from baseline.
timeFrame: Baseline, 12 months, and 24 months
measure: The change in triglycerides (TG) at 12 months and 24 months from baseline.
timeFrame: Baseline, 12 months, and 24 months
measure: The change in fasting blood glucose at 12 months and 24 months from baseline.
timeFrame: Baseline, 12 months, and 24 months
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.