An Observational Study to Assess the Feasibility and Variability of Physical Assessments Performed by People 45 Years of Age or Older Who Are Overweight or Obese
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.
研究概览
简要总结
Variability of physical assessments in an older population that is overweight or obese.
详细描述
The purpose of this study is to understand difficulty in obtaining physical assessment measurements and assess the variability of these assessments when performed by people who are overweight or obese. Data collected in this protocol will be used to inform the design of future clinical studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A written informed consent must be obtained before any study-related assessment is conducted.
- •Men and women aged ≥
- •BMI ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g. hypertension, cardiovascular disease, hyperlipidemia, elevated fasting blood sugar levels, sleep apnea).
- •Participants must be able to communicate well with the Investigator and comply with the study requirements.
排除标准
- •Participant weight > 150 kg.
- •Systolic blood pressure < 90 or > 180 or diastolic blood pressure <50 or >
- •Heart rate ≤ 50 or ≥
- •Unstable medical condition that would put the participant at risk by performing the study assessments.
- •Chronic medical condition rendering participants unable to perform the assessment, e.g., severe knee osteoarthritis.
结局指标
主要结局
To assess the variability of the 30 Second Chair Stand (30CST) results within and between participants.
时间窗: Baseline (+7 day window)
To compare the variability between the 5 Repetition Sit to Stand (5STS) subtest of the SPPB and 30CST.
时间窗: Baseline (+7 day window)
To assess the variability of grip strength results (kg) with the use of a hand grip dynamometer within and between participants.
时间窗: Baseline (+7 day window)
To assess the variability of the individual Short Physical Performance Battery (SPPB) with subsets (subsets of Balance, Gait and Chair Stand scored 0-4) within participants.
时间窗: Baseline (+7 day window)
To assess the correlation between bioelectrical impedance analysis (BIA) and waist circumference (WC) as well as body mass index (BMI).
时间窗: Baseline (+7 day window)
To assess the variability of Short Physical Performance Battery (SPPB, scored from 0-12) results within and between participants.
时间窗: Baseline (+7 day window)
次要结局
未报告次要终点