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

February 19, 2026 updated by: Xiufang Hong, Zhejiang Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • 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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310013
        • Zhejiang Hospital

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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age≥65 years
  2. Ability to understand and communicate in Chinese
  3. Sufficient hearing and vision to complete assessments
  4. Ability to walk independently or with assistive devices

Exclusion Criteria:

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONS & Resistance Training Group
Combination product: Combined ONS and Resistance Training Program

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fried frailty phenotype (FP) score
Time Frame: Baseline; At 12 weeks post-intervention
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
Time Frame: Baseline; At 12 weeks post-intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
mini nutritional assessment-short form(MNA-SF) score
Time Frame: Baseline; At 12 weeks post-intervention
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.
Baseline; At 12 weeks post-intervention
body mass index (BMI)
Time Frame: Baseline; At 12 weeks post-intervention
Calculated from measured height (meters) and weight (kilograms) using the formula: weight (kg) / [height (m)]2. Unit: kg/m2.
Baseline; At 12 weeks post-intervention
activities of daily living (ADL) score
Time Frame: Baseline; At 12 weeks post-intervention
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.
Baseline; At 12 weeks post-intervention
instrumental activities of daily living (IADL) score
Time Frame: Baseline; At 12 weeks post-intervention
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.
Baseline; At 12 weeks post-intervention
performance-oriented mobility assessment (POMA) score
Time Frame: Baseline; At 12 weeks post-intervention
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.
Baseline; At 12 weeks post-intervention
grip strength
Time Frame: Baseline; At 12 weeks post-intervention
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).
Baseline; At 12 weeks post-intervention
serum level of transferrin (TFN)
Time Frame: Baseline; At 12 weeks post-intervention
Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.
Baseline; At 12 weeks post-intervention
serum level of prealbumin (PA)
Time Frame: Baseline; At 12 weeks post-intervention
Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.
Baseline; At 12 weeks post-intervention
serum level of albumin (ALB)
Time Frame: Baseline; At 12 weeks post-intervention
Peripheral venous blood. Samples will be destroyed in accordance with the hospital's biosafety management protocols after laboratory testing is completed.
Baseline; At 12 weeks post-intervention

Collaborators and Investigators

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

Sponsor

Zhejiang Hospital

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

Helpful Links

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)

March 21, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Clinical Review 2023 No.21K
  • 2018KY198/2022ZH002/2023KY442 (Other Grant/Funding Number: Zhejiang Provincial Medical and Health Science and Technology Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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