Evaluating the Feasibility and Acceptability of Vivo, an Online, Live and Interactive Strength Training Program, in Sedentary Older Adults With Prediabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Leg Strength Assessed Through a 30 Second Chair Rise Test
研究概览
简要总结
This research trial studies the effect of an online, live and interactive strength training program on physical function and strength in older adults with prediabetes.
详细描述
It is well established that in-person resistance training is an effective form of exercise to increase physical function and quality of life amongst adults. However, older adults report not participating in resistance training due to lack of age appropriate programs, fear of a gym setting, poor access to a gym, joint and other kinds of pain, and lack of social support. These barriers have been compounded as a result of COVID-19 pandemic, wherein older adults are encouraged to socially isolate, leading to even less physical activity. Vivo is a virtual small group exercise program designed for adults 55 and addresses these major barriers to strength training by coaching through an interactive online training session incorporating social support and social engagement.
The investigators plan is to test a highly attractive technology platform specifically designed to meet the needs of older adults to demonstrate that resistance training exercise can be scaled and effective with diverse older adults and remove the barrier of having to go to a gym setting to see benefits. The investigators will test feasibility in a real world sample of adults ≥60 with prediabetes, a very prevalent, serious and often silent health condition that affects 1 in 3 adults in the US and is associated with high rates of sarcopenia, or loss of muscle mass.
In the next study, Phase II NCT06458530, investigators will examine the effects of Vivo on physical function and glycemic level in sedentary older with prediabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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;
- •Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%
- •Ambulatory and community-dwelling
- •Sedentary: less than 150 minutes of moderate physical activity OR less than 75 minutes of vigorous physical activity per week
- •Have not engaged in resistance training for at least 6 months prior to enrollment
- •Low functioning (defined as able to do at least 1 chair stand without using hand in 30 second but unable to meet the moderate function criteria for age and gender)
- •Access to WiFi (or internet connection) in defined exercise space
- •Willing to maintain weight and current diet throughout the study
排除标准
- •Inability to complete physical function assessment or inability to do a chair stand without using hands.
- •Use of antidiabetic medications
- •Use of testosterone supplement or replacement
- •Clinical disorder precluding/interfering with participation or assessments
- •Unstable angina, arrhythmia, uncontrolled hypertension
- •End Stage Renal Disease on Hemodialysis
- •Lower extremity amputation or paralysis
- •Neurological conditions causing functional or pronounced cognitive impairments
- •Active malignancy except for non-melanomatous skin cancers
- •Unable to provide consent
- •Weight instability
结局指标
主要结局
Leg Strength Assessed Through a 30 Second Chair Rise Test
时间窗: at 3 months (endpoint)
Participants completed as many chair stands as they could in 30 seconds
Workout Attendance
时间窗: after each workout session for up to 3 months (endpoint)
Attendance to each workout session was tallied. A possible 24 workout sessions were offered for the intervention (12 weeks of 2 days a week for workouts). The number of participants includes everyone who completed intervention, excluding those who stopped intervention at some point. The data reported represents the overall percent attendance of the participants that completed the intervention (N=22 participants). Attendance was calculated by averaging the number of sessions attended divided by the total number of exercise sessions attended (24 sessions).
Intervention Engagement Assessed by Self- Reported Ease of Use
时间窗: at 3 months (endpoint)
Participants completed a questionnaire (Likert Scale) on their experience using Vivo. 1= Strong Disagree to 5= Strongly Agree
Program Satisfaction
时间窗: at the 3 month (endpoint)
Participants completed the question on a questionnaire to answer "What was your overall satisfaction with Vivo?" Responses are percentage of participant who reported being satisfied or very satisfied with the Vivo intervention. A higher number indicates higher satisfaction.
Exercise Intervention Trainer Fidelity Checklist
时间窗: over the course of the 12 week intervention
The exercise intervention fidelity as assessed at 4 time points over the course of the 12-week exercise program using a 9-item checklist to ensure unbiased assessment. The purpose was to observe the exercise session to see if the main areas of the intervention were being delivered; workout intensity, safety, and participation and engagement. The results below indicate the percentage of exercise workouts that met the 9-item checklist. A higher score indicates higher fidelity.
次要结局
未报告次要终点
研究者
Eric Levian
CEO
Impactiv, Inc.