On the Move: Optimizing Participation in Group Exercise to Prevent Walking Difficulty in At-Risk Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Change in Self-reported Overall Function From Baseline to 12 Weeks
研究概览
简要总结
Community-dwelling older adults fear loss of independence and nursing home placement more than death. Walking difficulty often leads to loss of independence. Exercise is beneficial to physical and mental health and may prevent walking difficulty and promote independence. Recognizing the importance of exercise, senior housing facilities offer exercise programs to their residents. The exercise programs are often group-based, seated range of motion exercises that do not challenge the older adult; consequently participation rates and resident satisfaction are low.
If the goal is to improve walking to promote independence than the exercise program should specifically target walking. Therefore, we developed a challenging, group exercise program entitled "On the Move" which focuses on the fundamentals of walking. In this research study we will determine if the On the Move program is better than a standard program at improving walking and promoting independence and if the same benefits can be obtained if the On the Move program is delivered by staff of the senior living facilities instead of an exercise leader. To answer these questions, 400 community-dwelling older adults living in 32 different Independent Living Facilities and Senior High Rises or living in the community and attending senior community centers will be randomly assigned to either the 12 week On the Move group exercise program or the standard group exercise program delivered by either an exercise leader or staff activity personnel. Participants' walking and reported ability to carry out everyday activities (functional ability) will be assessed before and after the 12 week program. We will also assess participant safety and satisfaction with the exercise program and instructor.
The findings from this research study will provide evidence for the value of the On the Move group exercise program and will better inform patient choices regarding participation in exercise programs. If successful in improving walking and promoting independence and acceptable to the older adult, the On the Move program could be incorporated into exercise programming for older adults in community centers, health clubs, and senior residences across the country.
详细描述
This single-blinded cluster randomized trial compares the effectiveness and sustainability of On the Move and a standard group exercise program in 400 community-dwelling older adults. We will also examine the acceptability and risks associated with exercise participation. We will accomplish the objectives by pursuing the following specific aims:
- Compare the effects of the On the Move group exercise program to a standard program on self-reported function and disability and walking ability. The On the Move program will produce greater gains in self-reported function and disability (Late Life Function and Disability Index/LLFDI) and walking ability (6-minute walk test/6MWT and gait speed) when delivered by an exercise leader.
- When feasible to be delivered by staff activity personnel, explore the effectiveness of On the Move compared to a standard program; and sustainability compared to delivery by exercise leaders (when feasible). Explore barriers to identifying and training staff activity personnel. On the Move delivered by staff activity personnel (when feasible) will produce gains in above outcomes that are greater than the standard program; and comparable to when delivered by an exercise leader.
- Compare the acceptability and the risks of the On the Move and standard exercise programs delivered by (a) exercise leaders and (b) staff activity personnel (when feasible). On the Move will result in greater satisfaction and higher attendance rates than the standard program. Attendance rates and satisfaction will be similar for exercise leader and staff activity personnel led programs when feasible to recruit staff personnel. Adverse event (falls, soft tissue injuries, muscle soreness, etc) rates during exercise will be similar between the two groups and the two facilitators when feasible to recruit staff personnel.
- Explore potential baseline predictors of benefit and risks of participation in On the Move program to facilitate informed patient decision making. We will be able to identify combinations of baseline physical, psychosocial and demographic factors associated with each of the treatment response and adverse events outcomes.
This single-blinded cluster randomized trial targets community-dwelling older adults residing in Independent Living Facilities and Senior High Rises or living in the community and attending senior community centers. The trial compares type of exercise program (12 week standard group exercise program to the 12 week On the Move group exercise program) and the mode of delivery (exercise leader to staff activity personnel). Primary outcomes include function, disability and walking ability. We will also examine acceptability and risks associated with exercise participation.
Study population We will recruit participants from the Independent Living Facilities (ILFs), Senior Housing sites and from senior community centers.
Interventions:
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
- Single (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
- 是
入选标准
- •65 years of age or older
- •resident of University of Pittsburgh Medical Center Independent Living Facility or senior housing site
- •Ambulate independently for household distance (may use a straight cane)
排除标准
- •non English speaking
- •impaired cognition defined as unable to follow 2 step commands
- •plans to leave area in next 4 months
- •progressive neuromuscular disorder
- •any acute illness or medical condition that is not stable
- •inappropriate response on 6 minute walk test
研究组 & 干预措施
On the Move Exercise - exercise leader
On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Led by exercise leader
干预措施: On the Move exercise - exercise leader (Behavioral)
Standard program - exercise leader
Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Led by exercise leader
干预措施: Standard program - exercise leader (Behavioral)
On the Move - staff activity personnel
On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Led by activity personnel.
干预措施: On the Move exercise - staff activity personnel (Behavioral)
Standard - staff activity personnel
Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Led by staff activity personnel
干预措施: Standard program - staff activity personnel (Behavioral)
结局指标
主要结局
Change in Self-reported Overall Function From Baseline to 12 Weeks
时间窗: baseline and 12 weeks
Late Life Function and Disability Index (LLFDI) overall function. Scores range from 0-100 with higher score representing better function.
Change in Self-reported Disability From Baseline to 12 Weeks
时间窗: 12 weeks
Late Life Function and Disability Instrument (LLFDI) disability frequency component. Scores range from 0-100 with higher scores representing better (less) disability.
Change in Gait Speed From Baseline to 12 Weeks
时间窗: 12 weeks
Gait speed in m/s
Change in Six Minute Walk Distance From Baseline to 12 Weeks
时间窗: 12 weeks
distance walked in 6 minutes
次要结局
- Number of Participants Who Reported They Benefited a Good Bit or Somewhat From the Class(12 weeks)
- Number of Participants Who Reported That the Class Was at Least Somewhat Challenging(12 weeks)
- Number of Participants Reporting That They Received a Just Right Amount of Individualized Instruction(12 weeks)
- Number of Participants Who Reported That They Felt Safe or Very Safe During the Exercise.(12 weeks)
- Number of Participants Who Reported They Were Satisfied or Very Satisfied With the Program.(12 weeks)
- Number of Participants Who Reported They Would Definitely or Probably Continue With the Program(12 weeks)
- Change in Narrow Walk Time From Baseline to 12 Weeks(12 weeks)
- Change in Figure 8 Walk Test From Baseline to 12 Weeks(12 weeks)
- Change in Modified Gait Efficacy Scale From Baseline to 12 Weeks(12 weeks)
- Change in Short Physical Performance Battery From Baseline to 12weeks(12 week)
- Change in Stance Time Variability From Baseline to 12weeks(12 week)
研究者
Jennifer S. Brach
Associate Professor
University of Pittsburgh