Validity of an iPhone App to Detect Frailty and Sarcopenia Syndromes in Community Dwelling Older Adults: Protocol for a Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 775
- 试验地点
- 1
- 主要终点
- Sarcopenia
研究概览
简要总结
Frailty and sarcopenia are two age-related syndromes which can result in adverse health-related events. The combination of both is more predictive of mortality than either condition alone. These conditions can be reversed through an early detection and appropriate interventions. Nevertheless, scientific community highlights the lack of cheap, portable, rapid and easy-to-use tools for detecting frailty and sarcopenia in combination. The aim of this study is to validate an iPhone App to detect frailty and sarcopenia syndromes in community dwelling older adults. This is a protocol study of a retrospective diagnostic test accuracy study which will include at least 400 participants older than 60 years recruited from elderly social centers of Murcia city. Researchers will recollect data of health status, dependency, cognitive status, and functional capacity of the participants. The index test will consist in the measurement of muscle power exerted during a single Sit-to-stand through an App (iPhone), combined with calf and mid-upper arm circumference. The reference standard will be frailty syndrome and sarcopenia assessed according to Fried's phenotype and to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) (2019) recommendations, respectively. Sensitivity, specificity, positive predictive value, negative predictive values, and area under the curve will be reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-dwelling older adults living in the Region of Murcia
排除标准
- •Barthel Index < 90 pts.
- •Mini-Cog test < 3 pts.
- •Severe cardiovascular problems
- •Pacemaker
- •Automatic defibrillator
结局指标
主要结局
Sarcopenia
时间窗: Cross-sectional baseline
Sarcopenia will be assessed according to the recommendation provided by the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) (2019). This guideline focuses on the assessment of: 1. Leg muscle strength 2. Muscle mass quantity 3. Physical performance The presence of low muscle strength levels will be considered as "probable sarcopenia"; the presence of low muscle mass and strength levels will be considered as "confirmed sarcopenia"; finally, the presence of the three criteria will be considered as "severe sarcopenia".
Muscular power
时间窗: Cross-sectional baseline
Muscular power generated by participants will be measured using an App (Sit-to-stand App version 1.1) installed on an iPhone (Apple Inc., USA). During the execution, subjects will sit on a rigid chair with their arms crossed over their chest with the hip, knee and ankle joints at approximately 90 degrees. Subjects will be asked to stand-up as fast as possible. Participants will complete three STS repetitions. No footwear will be allowed during the test.
Frailty Syndrome
时间窗: Cross-sectional baseline
Frailty Syndrome will be assessed according to Fried's Phenotype, which focuses on: 1. Handgrip strength 2. Usual gait speed 3. Weight loss 4. Exhaustion 5. Physical activity levels Subjects who will result positive to three out of five criteria will be considered as "frail", whereas if they will result positive to only one or two of them they will be considered as "pre-frail". The absence of each criteria will be necessary to define a subject as "robust".
Calf and mid-upper arm circumference
时间窗: Cross-sectional baseline
Researchers will measure subjects' calf and mid-upper arm circumference using a tape measure.
次要结局
- Subjects' clinical status(Cross-sectional baseline)
研究者
Alessio Montemurro
Principal Investigator
Catholic University of Murcia