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Frail Elderly People HospitalizedNCT07429630

Predictors of Physical Improvement in Frail Hospitalized Elders After Nutrition and Exercise

A study testing Combined ONS and Resistance Training Program in people with Frail Elderly People Hospitalized, run by Zhejiang Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate whether a 12-week program combining oral nutritional supplements (ONS) with resistance exercises can improve nutritional status, muscle strength, and physical mobility in hospitalized older adults with frailty. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frail Elderly People Hospitalized
What is being tested?
Combined ONS and Resistance Training Program
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
21 Mar 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age≥65 years
  • Ability to understand and communicate in Chinese
  • Sufficient hearing and vision to complete assessments
  • Ability to walk independently or with assistive devices

Who cannot join

  • Acute cardiovascular or cerebrovascular diseases
  • Terminal illnesses
  • Severe cognitive impairment (determined by the ward's doctor and physiotherapists).

Trial locations and contacts

1 site in 1 country.

China1 site
  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310013

Other trials in China

About this study

Official title: An Exploratory Analysis of a Frailty Management Program: Identifying Characteristics Associated With Improved Physical Performance Following a Combined Nutrition and Exercise Intervention in Hospitalized Frail Older Adults

This study aims to evaluate whether a 12-week program combining oral nutritional supplements (ONS) with resistance exercises can improve nutritional status, muscle strength, and physical mobility in hospitalized older adults with frailty. The investigators will enroll about 120 frail older inpatients in a single-group design. All participants will receive 90 grams of ONS daily and undergo supervised resistance training five times per week for 12 weeks. Nutrition, physical function, and frailty levels will be assessed before and after the intervention. Baseline characteristics will be examined as potential predictors of intervention response.

Being tested
Combined ONS and Resistance Training Program
Keywords
frail older adults, oral nutritional supplementation, resistance exercise, nutrition, physical function status

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined ONS and Resistance Training ProgramCombination product

    Standardized Combined Intervention (Nutrition + Exercise):

    A 12-week integrated protocol for all participants. Oral Nutritional Supplement (ONS): Daily intake of 90g whole-protein enteral nutrition powder (450 kcal, 18g protein), dissolved in water and administered in two divided doses. This provides an estimated 30% increase in daily caloric intake.

    Supervised Resistance Training: Performed 5 times/week using Thera-Band resistance bands. Each 30-minute session includes warm-up, 6 standardized exercises (e.g., front raise, squat, leg abduction) targeting major muscle groups (2-3 sets of 8-12 repetitions each), and cool-down. Exercise intensity and adherence are monitored and progressed biweekly by trained staff.

    Note: This condensed version retains all critical components (dose, frequency, duration, standardization, supervision, and key exercise descriptions) for protocol replication, within a concise format suitable for study registries or summary documents.

Study groups in NCT07429630
Study groupRoleWhat they receive
ONS & Resistance Training GroupExperimentalNot described
Receives: Combination Product: Combined ONS and Resistance Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fried frailty phenotype (FP) score

    Assessed using the Fried Frailty Phenotype (FP) criteria, which includes five components: (1) unintentional weight loss, (2) weakness (grip strength), (3) poor endurance and energy (self-reported exhaustion via CES-D scale), (4) slowness (walking speed), and (5) low physical activity level (MLTA questionnaire). Frailty is defined as meeting three or more criteria. The Fried Frailty Phenotype (FP) score ranges from 0 to 5, with higher scores indicating a greater severity of frailty.

    Measured: Baseline; At 12 weeks post-intervention

  2. short physical performance battery (SPPB) score

    Comprises three components: balance tests (side-by-side, semi-tandem, and tandem stands), 4-meter walk speed test, and five times sit-to-stand test. Each component is scored from 0 to 4, yielding a total score ranging from 0 to 12. The Short Physical Performance Battery (SPPB) score ranges from 0 to 12 and higher scores reflect better lower extremity function.

    Measured: Baseline; At 12 weeks post-intervention

Secondary outcomes (9)
  1. mini nutritional assessment-short form(MNA-SF) score

    Assessed using the Mini Nutritional Assessment-Short Form. This 6-item tool screens for malnutrition risk by evaluating weight loss, food intake, mobility, psychological stress, body mass index, and disease. Total scores range from 0 to 14, with scores ≤7 indicating malnutrition, 8-11 indicating at risk of malnutrition, and ≥12 indicating normal nutritional status. The Mini Nutritional Assessment-Short Form (MNA-SF) score ranges from 0 to 14, with higher scores indicating better nutritional status.

    Measured: Baseline; At 12 weeks post-intervention

  2. body mass index (BMI)

    Calculated from measured height (meters) and weight (kilograms) using the formula: weight (kg) / [height (m)]2. Unit: kg/m2.

    Measured: Baseline; At 12 weeks post-intervention

  3. activities of daily living (ADL) score

    Assessed using the Barthel Index. This scale evaluates ten activities: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair/bed transfer, ambulation, and stair climbing. The Activities of Daily Living (ADL) scale based on the Barthel Index score ranges from 0 to 100, with higher scores indicate greater independence.

    Measured: Baseline; At 12 weeks post-intervention

  4. instrumental activities of daily living (IADL) score

    This scale evaluates evaluates eight domains of function: ability to use a telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances. The total score ranges from 0 (low function, dependent) to 8 (high function, independent) . A higher score on the IADL scale indicates a greater level of independence in performing these instrumental activities of daily living.

    Measured: Baseline; At 12 weeks post-intervention

  5. performance-oriented mobility assessment (POMA) score

    Assessed using the Tinetti Balance and Gait Evaluation. The scale consists of a balance section (9 items, max 16 points) and a gait section (7 items, max 12 points). Total scores range from 0 to 28, with higher scores indicating better balance and gait, and lower fall risk.

    Measured: Baseline; At 12 weeks post-intervention

  6. grip strength

    Measured using a handheld electronic dynamometer. The participant is seated or standing with the elbow flexed at 90°, forearm and wrist in a neutral position. Maximum force is applied with the dominant hand. The best of two attempts is recorded. Unit: kilograms (kg).

    Measured: Baseline; At 12 weeks post-intervention

  7. serum level of transferrin (TFN)

    Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.

    Measured: Baseline; At 12 weeks post-intervention

  8. serum level of prealbumin (PA)

    Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.

    Measured: Baseline; At 12 weeks post-intervention

  9. serum level of albumin (ALB)

    Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.

    Measured: Baseline; At 12 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start21 Mar 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm, prospective, pre-post intervention study. All enrolled frail older inpatients will receive a standardized 12-week combined intervention consisting of daily oral nutritional supplements and supervised resistance training. The primary analysis will compare outcomes (e.g., physical function, nutritional status) between baseline and post-intervention assessments. Additionally, an exploratory responder analysis is planned to identify baseline predictors of functional improvement based on achieving the Minimal Clinically Important Difference in the Short Physical Performance Battery.
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07429630
Sponsor's protocol ID
Clinical Review 2023 No.21K
Other IDs
2018KY198/2022ZH002/2023KY442
Status last verified
Feb 2026
First submitted
12 Feb 2026
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in the primary publication (including baseline characteristics, outcome measures, and analysis data sets) will be made available upon reasonable request to the corresponding author, beginning 9 months after article publication and ending 5 years thereafter. Proposals for data use will be reviewed by the study investigators. Requestors will need to sign a data access agreement specifying the intended use of the data, commitment to using it only for the agreed purpose, and agreement not to attempt to re-identify participants.

Publications

  • Yu P L, Wang J Y. Strengthening the research on prevention and treatment of frailty syndrome in the elderly[J]. Chinese Journal of Geriatrics, 2015, 34(12): 1281.

  • Hou X L, Gao J, Wu C X, et al. Frailty status and analysis among the elderly in nursing homes[J]. Chinese Journal of Nursing, 2018, 53(01): 88-93.

  • Liu H X, Yan A Y, Yu W J, et al. Research progress on causes and adverse health outcomes of frailty in the elderly[J]. China Journal of Modern Medicine, 2019, 29(15): 53-57.

  • Dent E, Lien C, Lim WS, Wong WC, Wong CH, Ng TP, Woo J, Dong B, de la Vega S, Hua Poi PJ, Kamaruzzaman SBB, Won C, Chen LK, Rockwood K, Arai H, Rodriguez-Manas L, Cao L, Cesari M, Chan P, Leung E, Landi F, Fried LP, Morley JE, Vellas B, Flicker L. The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty. J Am Med Dir Assoc. 2017 Jul 1;18(7):564-575. doi: 10.1016/j.jamda.2017.04.018.

    PubMed 28648901
  • Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.

    PubMed 25468154
  • Bock JO, Konig HH, Brenner H, Haefeli WE, Quinzler R, Matschinger H, Saum KU, Schottker B, Heider D. Associations of frailty with health care costs--results of the ESTHER cohort study. BMC Health Serv Res. 2016 Apr 14;16:128. doi: 10.1186/s12913-016-1360-3.

    PubMed 27074800
  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PubMed 23395245
  • Kojima G. Frailty Defined by FRAIL Scale as a Predictor of Mortality: A Systematic Review and Meta-analysis. J Am Med Dir Assoc. 2018 Jun;19(6):480-483. doi: 10.1016/j.jamda.2018.04.006.

    PubMed 29793675
  • Kojima G. Frailty as a predictor of disabilities among community-dwelling older people: a systematic review and meta-analysis. Disabil Rehabil. 2017 Sep;39(19):1897-1908. doi: 10.1080/09638288.2016.1212282. Epub 2016 Aug 24.

    PubMed 27558741
  • Kojima G. Frailty as a predictor of fractures among community-dwelling older people: A systematic review and meta-analysis. Bone. 2016 Sep;90:116-22. doi: 10.1016/j.bone.2016.06.009. Epub 2016 Jun 15.

    PubMed 27321894
  • Cheng MH, Chang SF. Frailty as a Risk Factor for Falls Among Community Dwelling People: Evidence From a Meta-Analysis. J Nurs Scholarsh. 2017 Sep;49(5):529-536. doi: 10.1111/jnu.12322. Epub 2017 Jul 29.

    PubMed 28755453
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156

Questions about this trial

What is this clinical trial studying?

A study testing Combined ONS and Resistance Training Program in people with Frail Elderly People Hospitalized, run by Zhejiang Hospital 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 3 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: finished, as of the sponsor's last update on 24 Feb 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Fried frailty phenotype (FP) score (time frame: Baseline; At 12 weeks post-intervention). The study lists 2 primary outcomes in all. 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 NCT07429630, which also lists 12 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 24 Feb 2026.

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