Frail Elderly People Hospitalized
Conditions
Keywords
frail older adults, oral nutritional supplementation, resistance exercise, nutrition, physical function status
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.
Interventions
COMBINATION_PRODUCTCombined 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.
Sponsors
Zhejiang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fried frailty phenotype (FP) score | 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. |
| short physical performance battery (SPPB) score | 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
| Measure | Time frame | Description |
|---|---|---|
| mini nutritional assessment-short form(MNA-SF) score | 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. |
| body mass index (BMI) | 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. |
| activities of daily living (ADL) score | 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. |
| instrumental activities of daily living (IADL) score | 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. |
| performance-oriented mobility assessment (POMA) score | 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. |
| grip strength | 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). |
| serum level of transferrin (TFN) | 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. |
| serum level of prealbumin (PA) | 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. |
| serum level of albumin (ALB) | 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. |
Countries
China
Outcome results
None listed