NCT07429630

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 12, 2026

Last Update Submit

February 19, 2026

Conditions

Frail Elderly People Hospitalized

Keywords

frail older adultsoral nutritional supplementationresistance exercisenutritionphysical function status

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline; At 12 weeks post-intervention

  • 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.

    Baseline; At 12 weeks post-intervention

Secondary Outcomes (9)

  • mini nutritional assessment-short form(MNA-SF) score

    Baseline; At 12 weeks post-intervention

  • body mass index (BMI)

    Baseline; At 12 weeks post-intervention

  • activities of daily living (ADL) score

    Baseline; At 12 weeks post-intervention

  • instrumental activities of daily living (IADL) score

    Baseline; At 12 weeks post-intervention

  • performance-oriented mobility assessment (POMA) score

    Baseline; At 12 weeks post-intervention

  • +4 more secondary outcomes

Study Arms (1)

ONS & Resistance Training Group

EXPERIMENTAL
Combination Product: Combined ONS and Resistance Training Program

Interventions

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.

ONS & Resistance Training Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

Location

Related Publications (12)

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 28648901RESULT

  • 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.

    PMID: 25468154RESULT

  • 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.

    PMID: 27074800RESULT

  • 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.

    PMID: 23395245RESULT

  • 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.

    PMID: 29793675RESULT

  • 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.

    PMID: 27558741RESULT

  • 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.

    PMID: 27321894RESULT

  • 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.

    PMID: 28755453RESULT

  • 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.

    PMID: 11253156RESULT

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 24, 2026

Study Start

March 21, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
De-identified IPD and supporting documents (study protocol, informed consent form) will become available 9 months after the publication of the primary results manuscript and will remain available for 5 years. Access will be provided upon reasonable request to the corresponding author and require a signed data use agreement.
Access Criteria
Access will be granted to qualified researchers (affiliated with academic or healthcare institutions) who provide a methodologically sound research proposal approved by the study investigators. Requestors can access de-identified IPD, study protocol, and informed consent form for the purpose of individual participant data meta-analysis, reproducibility checks, or secondary analysis aligned with the original study ethics. Proposals should be submitted to the corresponding author \[hongxf\ 1101@163.com\] and require a signed Data Access/Use Agreement that includes commitments to: (1) use data only for the specified purpose; (2) protect data confidentiality; (3) not attempt to re-identify participants; and (4) acknowledge the data source in publications.

Locations

CN(1)