Combined Exercise and Nutrition Intervention for Possible Sarcopenia Among Community-dwelling Older Adults in Primary Care: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 3
- 主要终点
- 5-time chair stand test
研究概览
简要总结
The purpose of this study is to assess the impact of a combined exercise-nutrition intervention in primary clinics on sarcopenia indices, physical function, and quality of life in community-dwelling older adults with possible sarcopenia.
详细描述
This study will investigate the effects of a 12-week combined exercise-nutrition intervention by comparing it with a control group receiving standard care (usual care) by assessing the sarcopenia indicators, functional recovery, and individual satisfaction. This is an interventional clinical study designed to recruit subjects, analyze data, identify problems, find improvement areas, and explore potential solutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 to 85 years of age
- •Men and women with possible sarcopenia
- •If included in the possible sarcopenia criteria in the 2019 Asian Working Group for Sarcopenia(AWGS) criteria A Simple Questionnaire to Rapidly Diagnose Sarcopenia(The Korean SARC-F questionnaire) score is 4 or higher; or Calf circumference (Men's: <34 cm, Women's: <33 cm) + Decreased muscle strength (male: <28kg, female: <18kg) or Decreased physical function (if it takes more than 12 seconds from the 5-chair stand test)
- •[(1) and {(2) or (3)}]
排除标准
- •Renal failure: Serum creatine exceeding 2.0 mg/dl
- •Uncontrolled hypertension: systolic/diastolic blood pressure greater than 150/90 millimeter of mercury(mmHg)
- •Uncontrolled diabetes: glycated hemoglobin (HbA1C) over 7.5%
- •Subject who are receiving treatment (steroids, anticancer drugs, etc.) that can affect muscle mass
- •Subjects with myocardial infarction or angina pectoris, stroke disease
- •Malignant tumor: Subject who has a history of cancer within 5 years or is currently receiving treatment
- •Subjects who have liver cirrhosis and uncontrolled hepatitis (Aspartate aminotransferase or Alanine aminotransferase is more than three times the upper limit of the reference range)
- •Subjects who have chronic diseases such as musculoskeletal disorders that are impossible to exercise
- •Subjects who are allergic to soybeans, coix, and brown rice
结局指标
主要结局
5-time chair stand test
时间窗: Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention
a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded.
次要结局
- Falls(0st week of intervention, 12th week of intervention, 24th week of intervention)
- EuroQol Visual Analogue Scale(EQ-VAS)(0st week of intervention, 12th week of intervention)
- Korean version of Physical Activity Scale for the Elderly(K-PASE)(0st week of intervention, 12th week of intervention)
- Korean version of Mini-mental State Examination(K-MMSE)(0st week of intervention, 12th week of intervention)
- Grip strength(Screening, 0st week of intervention, 6th week of intervention, 12th week of intervention)
- Mini Nutritional Assessment(MNA)(0st week of intervention, 12th week of intervention)
- Korean version of Short Form of Geriatric Depression Scale(SGDS-K)(0st week of intervention, 12th week of intervention, 24th week of intervention)
- Korean version of Instrumental Activities of Daily Living (K-IADL)(0st week of intervention, 6th week of intervention, 12th week of intervention, 24th week of intervention)
- The 12-item Health Survey(SF-12)(0st week of intervention, 12th week of intervention)
研究者
Chang Won Won
Principal Investigator
Kyunghee University Medical Center