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

December 13, 2025 updated by: Chong Shen, Nanjing Medical University

Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults: A Cohort-based Cluster- Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
934

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Suzhou Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
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

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.
No Intervention: Control group
Participants in the control arm will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change in handgrip strength at 6 months from baseline.
Time Frame: Baseline and 6 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.
Baseline and 6 months
The change in frailty index at 6 months and 12 months from baseline.
Time Frame: Baseline, 6 months, and 12 months
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.
Baseline, 6 months, and 12 months
The change in the quantity and frequency of fruit intake at 12 months from baseline.
Time Frame: Baseline and 12 months
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.
Baseline and 12 months
The change in physical activity volume and intensity at 12 months from baseline.
Time Frame: Baseline and 12 months
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.
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
12 months, and 24 months
The incidence of all-cause death over 12 and 24 months.
Time Frame: 12 months, and 24 months
12 months, and 24 months
The incidence of cardiovascular and cerebrovascular diseases over 12 and 24 months.
Time Frame: 12 months, 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.
Time Frame: Baseline, 12 months, and 24 months
Baseline, 12 months, and 24 months
The change in high density lipoprotein cholesterol (HDL-C) at 12 months and 24 months from baseline.
Time Frame: Baseline, 12 months, and 24 months
Baseline, 12 months, and 24 months
The change in total cholesterol (TC) at 12 months and 24 months from baseline.
Time Frame: Baseline, 12 months, and 24 months
Baseline, 12 months, and 24 months
The change in triglycerides (TG) at 12 months and 24 months from baseline.
Time Frame: Baseline, 12 months, and 24 months
Baseline, 12 months, and 24 months
The change in fasting blood glucose at 12 months and 24 months from baseline.
Time Frame: Baseline, 12 months, and 24 months
Baseline, 12 months, and 24 months
Incremental cost-effectiveness ratio (ICER)
Time Frame: Baseline and 12 months
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.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Suzhou Center for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GSKY20230103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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