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Completed

NCT Number: NCT07429630

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Combined ONS and Resistance Training Program

Combination 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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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