Active for Life Assisted Living Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Feasibility: Number of participants screened
研究概览
简要总结
This study examines the effects of a physical activity and behavioral program, called Active for Life, to promote increased physical activity and reduced sedentary behavior of older adults who live in assisted living. A sedentary lifestyle is very common in this population and if this program is successful it will be used to promote physical activity and improve the health of older adults in assisted living.
详细描述
Sedentary behavior (SB) is an emerging health risk, especially for older adults, as it is associated with chronic disease, loss of function, and increased disability and frailty. Older adults in assisted living (AL) are less active than their peers living independently. Recent evidence demonstrates there are substantial health benefits from light physical activity (LPA) and the newly published Physical Activity Guidelines for Americans recommends that older adults replace SB with LPA. An intervention to increase LPA and reduce SB has potential to reduce health risks, slow functional decline and frailty, and delay residents' needs for higher-level care such as a nursing home. We propose to test the feasibility and acceptability of a self-efficacy based intervention, "Active for Life," with the goal of increasing PA and decreasing SB of AL residents.
Active for Life is a 12 week intervention. Key components include (a) exercise with functional circuit training (FCT), walking, and stretching, (b) a behavioral component with a structured self-efficacy enhancing intervention that includes self-regulation strategies, and (c) education that addresses principles of exercise, the distinct health benefits of LPA, the negative consequences of too much sedentary time, and strategies for overcoming barriers to physical activity. It is important to test the feasibility and acceptability of the intervention for AL residents because this population will be more frail than previously tested populations. The intervention has been modified to be appropriate for AL residents based on guidance from AL experts and individual interviews conducted with AL residents. We will enroll 27 participants from approximately four AL facilities. Outcomes will be measured at baseline and at conclusion of the intervention. The primary outcomes are feasibility and acceptability of the intervention, but we will also examine preliminary evidence of outcome measures of objectively-measured sedentary behavior and physical activity, self-efficacy for exercise, value of physical activity, self-rated health, physical function, anxiety, depression, pain interference, and fatigue. This study is innovative because there are no well-established evidence-based interventions to promote PA in the AL setting and none that focus on increasing LPA and decreasing SB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residing in assisted living facility
- •Inactive (performing moderate level activities for less than 30 min./day, 5 day/week or not performing muscle strengthening activities twice/week) or a desire to increase physical activity
- •Score of at least 3 on the Mini-Cog cognitive screening
排除标准
- •Mobility issues that prevent participation in PA, such as if they rely on a wheelchair or motorized scooter (not excluded if they require an assistive device such as a cane or walker)
- •Hospitalization in the previous month
- •Skin on the thigh where ActivPAL monitor would be placed is not intact (has lesions, signs of infection, rash, or skin breakdown)
结局指标
主要结局
Feasibility: Number of participants screened
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will calculate how many participants volunteered to be screened for participation in the study.
Feasibility: Documentation of stated reasons for participant dropout
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will document stated reasons for dropout from the study as much as we are able.
Feasibility: Number of participants eligible
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will calculate how many participants met eligibility criteria for study participation.
Feasibility: Participant retention rates
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will calculate retention rates of how many participants started and how many completed the study.
Feasibility: Injuries and adverse events
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will summarize any adverse events/injuries that occur during the study.
Feasibility: Rates of missing or unusable data
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will summarize how much data are missing from baseline, mid-intervention, and post-intervention data collections.
Feasibility: Numbers of participants ineligible by each eligibility criterion
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will summarize reasons that participants were ineligible for study participation by adding up the number of people who don't meet each specific eligibility criterion.
Feasibility: Number of participants who enroll
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will calculate how many eligible participants decide to enroll in the study.
Feasibility: Length of time for recruitment activities
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will calculate how much time is spent to recruit the study sample.
Feasibility: Percentage of activity sessions attended by participants
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will calculate the percentage of activity sessions that participants attended.
Acceptability: Final acceptability scale
时间窗: After completion of the 12 week intervention
This scale consists of 13 questions related to participants' overall satisfaction with the intervention and its components. Higher score indicates greater intervention acceptability.
Feasibility: Time required to complete outcome measures
时间窗: After completion of the 12 week intervention
Several measures will be used to describe the feasibility of the intervention. We will keep record of how long each data collection session takes and calculate average length of data collection at both baseline and post-intervention.
Acceptability: Exit interviews
时间窗: After completion of the 12 week intervention
Semi-structured exit interviews will ask questions related to acceptability of the intervention, such as how participants felt about the overall intervention and its specific components, whether the time commitment was reasonable, whether assisted living staff were supportive of their participation and goals, and any suggestions for future improvements.
次要结局
- Value of Physical Activity(Measured at baseline and after 12 week intervention.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health(Measured at baseline and after 12 week intervention.)
- PROMIS Depression(Measured at baseline and after 12 week intervention.)
- Time spent in sedentary behavior and physical activity(7 days of data are gathered at baseline at after the 12 week intervention.)
- Self-efficacy for exercise(Measured at baseline, three weeks, and after 12 week intervention.)
- PROMIS Fatigue(Measured at baseline and after 12 week intervention.)
- PROMIS Physical Functioning(Measured at baseline and after 12 week intervention.)
- PROMIS Anxiety(Measured at baseline and after 12 week intervention.)
- PROMIS Pain Interference(Measured at baseline and after 12 week intervention.)
- Positive and Negative Social Influences on PA in Older Adults(Measured at baseline and after 12 week intervention.)
- Acceptability: Mid-point acceptability scale(Measured at 6-weeks (mid-point of intervention))
研究者
Janet L. Larson
Professor
University of Michigan