Vivo Prediabetes Study: Evaluating the Effect of Participating in Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Lower body strength
研究概览
简要总结
This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.
详细描述
This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control. After informed consent and baseline assessments, up to 90 individuals will be randomized in one of two arms: 1) Vivo intervention or 2) waitlist control. Participants in the Vivo 2.0 intervention arm will meet virtually twice a week with their small group and certified trainer for 45 minutes over a 12-week period. Participants will be men and women, ≥60 years old, sedentary, with prediabetes and low function. All participants will undergo baseline and 12-week assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The PI will be masked to randomization assignment.
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
- •Age ≥ 60 years
- •Ambulatory and community-dwelling
- •Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%
- •Low functioning: 1) able to do at least 1 chair stand and 2) number of chair stands done in 30 seconds is below criterion-referenced fitness standards for maintaining physical independence for age and gender
- •Sedentary: less than 150 minutes of moderate physical activity OR less than 60 minutes of vigorous physical activity per week
- •Have not engaged in resistance training for at least 6 months prior to enrollment
- •Access to WiFi in defined exercise space
排除标准
- •Inability to complete physical function assessment
- •Use of antidiabetic medications
- •Use of testosterone supplement or replacement
- •Clinical disorder precluding/interfering with participation of assessments
- •Unstable angina, arrhythmia, uncontrolled hypertension
- •End Stage Renal Disease on Hemodialysis
- •Lower extremity amputation or paralysis
- •Neurological condition causing functional or pronounced cognitive impairments
- •Active malignancy except for non-melanomatous skin cancers
- •Weight instability (defined as gain or loss of ≥10% over the last 6 months)
- •Unable to provide consent
研究组 & 干预措施
Vivo intervention
Participants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes.
干预措施: Vivo (Behavioral)
Waitlist control
Participants randomized to this arm will be asked to maintain their baseline physical activity for 12-weeks. They will be scheduled for the baseline and 12-week assessment and following the 12-week assessment, they will be offered enrollment into Vivo.
结局指标
主要结局
Lower body strength
时间窗: baseline and 12 weeks
Lower body strength measured by the 30-second chair stand
次要结局
- Hemoglobin A1C (HbA1C)(baseline and 12 weeks)
- Aerobic Endurance(baseline and 12 weeks)
- Physical Activity Level(baseline and 12 weeks)
- Balance(baseline and 12 weeks)