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临床试验/NCT05725564
NCT05725564进行中(未招募)不适用

PCORI-HA-2021C3-25041 Comparative Effectiveness of Brief Strength and Balance Exercises and Standard Home-Based Group Exercise for Primary Care Patients With Mobility Disability

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 702 人开始时间: 2023年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
702
试验地点
1
主要终点
Physical Function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 65
  • Self reported difficulty or inability to walk 1/4/ mile
  • Access to the Internet
  • Covid vaccination

排除标准

  • 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

研究组 & 干预措施

FAST-BCT

Experimental

FAST exercise intervention without behavior change techniques applied. Daily exercise intervention including functional resistance training and personalized coaching.

干预措施: FAST (Functional Activity Strength Training) (Behavioral)

FAST+BCT

Experimental

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.

干预措施: FAST (Functional Activity Strength Training) (Behavioral)

FAST+BCT

Experimental

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.

干预措施: Behavioral Change Technique (Behavioral)

BT-BCT

Active Comparator

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.

干预措施: Band Together (Behavioral)

BT+BCT

Active Comparator

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.

干预措施: Band Together (Behavioral)

BT+BCT

Active Comparator

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.

干预措施: Behavioral Change Technique (Behavioral)

结局指标

主要结局

Physical Function

时间窗: 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.

次要结局

  • Gait Speed (10 meter walk test)(12 Months)
  • Walking Ability(12 Months)
  • Number of participants with a self-reported injury due to physical activities(Monthly up to 12 months)
  • Lower Extremity Performance(12 Months)
  • Dose Received(Through study completion, an average of 1 year)
  • Muscle Strength(12 Months)
  • Falls(12 Months)
  • Physical Activity(12 months)
  • Effort (Rating of Perceived Exertion)(Monthly up to 12 months)
  • Fatigue, Pain(12 Months)
  • Program Satisfaction(Monthly up to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Sciamanna, MD, MPH

Principal Investigator

Milton S. Hershey Medical Center

研究点 (1)

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