FrailtyEFVFNCT06225271
Effects of the Combined Intervention of Exercise, Fruit, and Vitamin Supplementation on Frailty in Older Adults
A study testing the combined intervention of exercise, fruit, and vitamin supplementation in people with Frailty, run by Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- the combined intervention of exercise, fruit, and vitamin supplementation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 934 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- the combined intervention of exercise, fruit, and vitamin supplementation
- Keywords
- Older adults, Frailty, Exercise, Fruit, Vitamin supplementation, Cluster- randomized controlled trial, Muscle loss
- Medical subject headings
- Frailty, Motor Activity, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the combined intervention of exercise, fruit, and vitamin supplementationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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). Receives: Behavioral: the combined intervention of exercise, fruit, and vitamin supplementation |
| Control group | No intervention | Participants in the control arm will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (13)
The change in handgrip strength at 6 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months
The incidence of a composite of all-cause death, cardiovascular and cerebrovascular diseases over 12 and 24 months.
Measured: 12 months, and 24 months
The incidence of all-cause death over 12 and 24 months.
Measured: 12 months, and 24 months
The incidence of cardiovascular and cerebrovascular diseases over 12 and 24 months.
Measured: 12 months, and 24 months
The change in low-density lipoprotein cholesterol (LDL-C) at 12 months and 24 months from baseline.
Measured: Baseline, 12 months, and 24 months
The change in high density lipoprotein cholesterol (HDL-C) at 12 months and 24 months from baseline.
Measured: Baseline, 12 months, and 24 months
The change in total cholesterol (TC) at 12 months and 24 months from baseline.
Measured: Baseline, 12 months, and 24 months
The change in triglycerides (TG) at 12 months and 24 months from baseline.
Measured: Baseline, 12 months, and 24 months
The change in fasting blood glucose at 12 months and 24 months from baseline.
Measured: Baseline, 12 months, and 24 months
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start8 Mar 2024
- Primary completion15 Apr 2025
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 934 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Chong Shen, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225271
- Sponsor's protocol ID
- GSKY20230103
- Acronym
- EFVF
- Status last verified
- Sep 2025
- First submitted
- 22 Dec 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28085913Kapan 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.
PubMed 28724351Kim H, Suzuki T, Kim M, Kojima N, Ota N, Shimotoyodome A, Hase T, Hosoi E, Yoshida H. Effects of exercise and milk fat globule membrane (MFGM) supplementation on body composition, physical function, and hematological parameters in community-dwelling frail Japanese women: a randomized double blind, placebo-controlled, follow-up trial. PLoS One. 2015 Feb 6;10(2):e0116256. doi: 10.1371/journal.pone.0116256. eCollection 2015.
PubMed 25659147Kwon 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.
PubMed 25659620Chen 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.
PubMed 37997729Li K, Shi T, Huang X, Shen C, Lu H. Implementation of Combined Exercise, Fruit Intake, and Vitamin Supplementation Interventions to Prevent Frailty in Older Adults: A RE-AIM QuEST Evaluation. Healthcare (Basel). 2026 Sep 28;14(19):3195. doi: 10.3390/healthcare14193195.
PubMed 42881633
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06225271
- Acronym / sponsor ID
- EFVF / GSKY20230103
- Conditions
- Frailty
- Keywords
- Older adults, Frailty, Exercise, Fruit, Vitamin supplementation, Cluster- randomized controlled trial, Muscle loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 934 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Suzhou Center for Disease Control and Prevention
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: the combined intervention of exercise, fruit, and vitamin supplementationParticipants 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). |
| Control group | No intervention | –Participants in the control arm will not receive any intervention. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the combined intervention of exercise, fruit, and vitamin supplementationGroup 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. | Behavioural | Intervention group |
Primary outcome
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.
13 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.
Time frame: 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
The change in physical activity volume and intensity at 12 months from baseline.
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.
Time frame: 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
The change in total cholesterol (TC) at 12 months and 24 months from baseline.
Time frame: 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
The change in fasting blood glucose at 12 months and 24 months from baseline.
Time frame: Baseline, 12 months, and 24 months
Incremental cost-effectiveness ratio (ICER)
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 28085913Haider 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.
- Results publication: PubMed 28724351Kapan 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.
- Results publication: PubMed 25659147Kim H, Suzuki T, Kim M, Kojima N, Ota N, Shimotoyodome A, Hase T, Hosoi E, Yoshida H. Effects of exercise and milk fat globule membrane (MFGM) supplementation on body composition, physical function, and hematological parameters in community-dwelling frail Japanese women: a randomized double blind, placebo-controlled, follow-up trial. PLoS One. 2015 Feb 6;10(2):e0116256. doi: 10.1371/journal.pone.0116256. eCollection 2015.
- Results publication: PubMed 25659620Kwon 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.
- Results publication: PubMed 37997729Chen 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.
- Derived from this study: PubMed 42881633Li K, Shi T, Huang X, Shen C, Lu H. Implementation of Combined Exercise, Fruit Intake, and Vitamin Supplementation Interventions to Prevent Frailty in Older Adults: A RE-AIM QuEST Evaluation. Healthcare (Basel). 2026 Sep 28;14(19):3195. doi: 10.3390/healthcare14193195.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the combined intervention of exercise, fruit, and vitamin supplementation in people with Frailty, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in handgrip strength at 12 months from baseline. (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225271, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.