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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Fried frailty phenotype (FP) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Acute cardiovascular or cerebrovascular diseases
- •Terminal illnesses
- •Severe cognitive impairment (determined by the ward's doctor and physiotherapists).
研究组 & 干预措施
ONS & Resistance Training Group
干预措施: Combined ONS and Resistance Training Program (Combination Product)
结局指标
主要结局
Fried frailty phenotype (FP) score
时间窗: 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
时间窗: 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.
次要结局
- 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)
- grip strength(Baseline; At 12 weeks post-intervention)
- serum level of transferrin (TFN)(Baseline; At 12 weeks post-intervention)
- serum level of prealbumin (PA)(Baseline; At 12 weeks post-intervention)
- serum level of albumin (ALB)(Baseline; At 12 weeks post-intervention)
研究者
Xiufang Hong
Associate Chief Physician
Zhejiang Hospital