通过锻炼测试移动性干预措施 (TIME) (TIME)
PCORI-HA-2021C3-25041 短期力量和平衡练习与标准家庭小组练习对行动不便的初级保健患者的比较效果
In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.
研究概览
地位
详细说明
One in four older adults, the fastest growing demographic group in the US, reports serious difficulty walking or climbing stairs. Older adults note that these walking difficulties "deprives you of your identity" and "affects my day to day life… I can't do very much work on my own." Walking difficulties impair people's quality of life more than depression, anxiety, or pain. Walking difficulties also increase the chances of future disability, death, and healthcare costs. Though strength training improves walking ability, fewer than one in five older adults do strength training enough to benefit. What is unknown is how to create a strength training program that improves the ability of older adults to walk and do other things they need and want to do and that older adults are willing to do.
One approach to designing a strength training program that has not been tried before is to make them shorter. In 2020, the project team set out to design a short strength training program that older adults could do at home that would improve their physical function and that they would consistently do. The program was called FAST (Functional Activity Strength Training) and, to make it more effective, the team set specific goals for how many additional repetitions each person should be able to do over 12 weeks. These goals were then mentioned repeatedly, and feedback was provided about how well people made progress toward these goals.
In the first study of FAST (FAST-1), 24 healthy older adults performed 30 seconds of squats and push-ups each day but received no personal supervision. Over six months, they performed the exercises on 73 percent of days, which led to large increases in the number of push-ups and squats they were able to do. In the second study of FAST (FAST-2), the team randomly assigned 97 older adults who had trouble walking, and those assigned to do 30 seconds each of chair stands and steps onto a stepper each day improved their ability to stand up from a chair and stand on one leg more than those who did not do the exercises.
In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.
This study will enroll 520 primary care patients who are at least 65 years of age and randomly assign them to have access to 12 months of daily FAST or three-times weekly BAND TOGETHER. Each program will be delivered via the internet and each patient will receive about 30 minutes per month of personal support. The study will enroll patients who have trouble walking, have access to the internet, can provide informed consent, and receive permission from their doctor. The study is designed to see whether patients who have access to FAST, after 12 months, have better walking ability, balance, and leg strength and can do their normal daily activities more easily and fall less often than patients who have access to BAND TOGETHER.
To help us understand how best to perform the study, as well as how best to share the results, the study team assembled a group of stakeholders that includes patients, primary care providers, fitness center directors, and people who work for insurance, public health, and senior services organizations. The team will bring those stakeholders together each year and consult them regularly to help make difficult decisions as they arise-decisions that may impact each group of stakeholders differently. Two patient partners will work with investigators to supervise the group of stakeholders and organize their feedback, structured as a public comment period, to help the research team make decisions that take into account the perspectives of all of the key groups of stakeholders involved in improving the physical function of older adults.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Pennsylvania
-
Hershey、Pennsylvania、美国、17033
- Penn State College of Medicine
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age greater than or equal to 65
- Self reported difficulty or inability to walk 1/4/ mile
- Access to the Internet
- Covid vaccination
Exclusion Criteria:
- Chest pain on the PAR-Q
- Participating in another research project involving physical activity, falls or weight loss
- Planning to move or have surgery in the next 12 months
- Cognitive impairment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:FAST-BCT
FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching. |
Daily exercise intervention including functional resistance exercises and personalized coaching. |
|
实验性的:FAST+BCT
FAST exercise intervention with behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort. |
Daily exercise intervention including functional resistance exercises and personalized coaching. Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence |
|
有源比较器:BT-BCT
Band Together exercise intervention without behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes. |
3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes |
|
有源比较器:BT+BCT
Band Together exercise intervention with behavior change techniques applied. 3 times weekly group exercise intervention held over Zoom featuring strength and balance exercises for 45 minutes with added reminders, education, goal setting, self monitoring, and feedback to encourage adherence and effort. |
Reminders, education, goal-setting, self-monitoring, and feedback used to encourage participants to increase effort and adherence 3 times weekly group exercise over Zoom featuring strength and balance exercises for 45 minutes |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical Function
大体时间:12 Months
|
Patient-Reported Outcomes Measurement Scale (PROMIS-29). The minimum and maximum values are unable to do and without any difficulty, and a higher score means a better outcome. |
12 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Lower Extremity Performance
大体时间:12 Months
|
Short Physical Performance Battery. The minimum value is a score of 0 points, the maximum value is a score of 16. A higher score means a better outcome. |
12 Months
|
|
Dose Received
大体时间:Through study completion, an average of 1 year
|
Sessions completed per week (percent) |
Through study completion, an average of 1 year
|
|
Effort (Rating of Perceived Exertion)
大体时间:Monthly up to 12 months
|
Rating of Perceived Exertion. The minimum value is 0 (at rest) and the maximum value is 10 (maximal). This is a purely subjective measure here a higher or lower score doesn't necessarily lead to a better outcome, but for our exercise study we have a target RPE of 5 for exercise. |
Monthly up to 12 months
|
|
Gait Speed (10 meter walk test)
大体时间:12 Months
|
Gait Speed (10 meter walk test). Participants undergo two trials (comfortable speed and fast speed), and an average of the two trials is used as the gait speed in m/s. |
12 Months
|
|
Muscle Strength
大体时间:12 Months
|
Upper and lower extremity strength |
12 Months
|
|
Walking Ability
大体时间:12 Months
|
6 Minute Walk Distance |
12 Months
|
|
Fatigue, Pain
大体时间:12 Months
|
Patient Reported Outcomes Measurement Scale (PROMIS-29). The minimum value for the fatigue scales is "not at all", the maximum value is "very much". A lower score means a better outcome. The minimum values for the pain scales are "not at all" and 0, the maximum values "very much" and 10. A lower value means a better outcome. |
12 Months
|
|
Falls
大体时间:12 Months
|
Percent experiencing a fall-related injury |
12 Months
|
|
Physical Activity
大体时间:12 months
|
Accelerometry over 7 days |
12 months
|
|
Number of participants with a self-reported injury due to physical activities
大体时间:Monthly up to 12 months
|
Injuries due to physical activities |
Monthly up to 12 months
|
|
Program Satisfaction
大体时间:Monthly up to 12 months
|
Net Promoter Score. The maximum value is 10 and the minimum value is 0. A higher value means a better outcome. |
Monthly up to 12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Weight (kg)
大体时间:12 Months
|
Body Weight (kg) |
12 Months
|
|
Height (cm)
大体时间:12 Months
|
Height (cm) |
12 Months
|
|
Sociodemographics, self-reported medical history and tobacco use
大体时间:Baseline
|
Age, gender, race and ethnicity, medical history, smoking status, and education |
Baseline
|
|
Caregiving Status Questions (Receiving and Providing)
大体时间:Monthly up to 12 months
|
Giving and receiving caregiving, paid or unpaid, for personal care needs, such as eating, bathing, dressing, or getting around inside the home. |
Monthly up to 12 months
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HA-2021C3-25041
- PCORI-HA-2021C3-25041 (其他标识符:PCORI)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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