Effectiveness of the On the Move Group Exercise Program to Improve Mobility in Community-dwelling Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 529
- 试验地点
- 1
- 主要终点
- Gait speed
研究概览
简要总结
The purpose of this study is to test the effectiveness of On the Move (OTM) in terms of improving mobility among 502 older adults in 44 senior community centers and to evaluate intervention fidelity, including adherence and competence, and the impact of organizational, instructor, and participant level factors on intervention fidelity.
详细描述
The investigators will conduct a Hybrid I trial, blending effectiveness and implementation research aims to: test the effectiveness of OTM, evaluate intervention fidelity, and determine the extent intervention fidelity moderates intervention effectiveness. The investigators will evaluate the effects of OTM taught by community instructors for improving mobility among 502 older adults in 44 community centers using a cluster randomized design with a delayed intervention control arm. Intervention fidelity will be assessed by instructor self-report (intervention diaries) and observation (fidelity checklist). Organizational, instructor, and participant level factors which may impact fidelity will be assessed via standard instruments, focus groups and interviews.
Specific Aims are as follows:
Aim 1: Establish the effectiveness of OTM on improvements in walking ability and post-intervention persistence of benefits.
Rationale: OTM delivered by research staff is effective. Establishing the effectiveness of OTM delivered by community instructors is necessary before wide-scale implementation.
Hypothesis: Compared to a randomized control group followed for 12 weeks, the OTM group will have greater gains in gait speed (primary outcome) and self-reported mobility at 12 and 24 weeks of follow-up.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years of age or older
- •attend the senior center
- •can ambulate household distances independently
- •can participate in group exercise classes
排除标准
- •impaired cognition (unable to understand consent process)
- •plans to leave the area for an extended period of time
- •any acute or unstable illness or medical condition
研究组 & 干预措施
On the Move
On the Move group exercise program to improve walking. Delivered twice per week for 12 weeks.
干预措施: On the Move group exercise (Behavioral)
On the Move - Delayed
Individuals in this arm will be placed on a wait-list for 12 weeks and will receive no intervention during this time. At the end of the 12 weeks they will receive the On the Move group exercise program. This is a wait-list control group.
干预措施: On the Move group exercise (Behavioral)
结局指标
主要结局
Gait speed
时间窗: 24 weeks
The time it take the subject to walk 4 meters and their usual walking speed. Recorded as m/s. Faster speeds indicate better mobility.
Gait speed
时间窗: 12 weeks
The time it take the subject to walk 4 meters and their usual walking speed. Recorded as m/s. Faster speeds indicate better mobility.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) mobility(24 weeks)
- Participant Satisfaction(immediately post intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) mobility(12 weeks)
研究者
Jennifer S. Brach
Professor and Associate Dean for Faculty Affairs and Development
University of Pittsburgh