Community-based Intervention Effects on Older Adults' Physical Activity and Falls (R01)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Quantity of Physical Activity Measured Objectively
研究概览
简要总结
The research team will conduct a 2 x 2 factorial experiment testing the individual and combined effects of two empirically and theoretically relevant sets of behavior change strategies on community-dwelling older adults' physical activity. To do this the investigators will randomize participants >= 70 years old (n = 308) to 1 of 4 experimental conditions. All conditions include an evidence-based physical activity protocol endorsed by Centers for Disease Control and Prevention (CDC) for use by all older adults, including those with frailty and multiple co-morbidities and the commercially available physical activity monitor (e.g., Fitbit) to augment intervention delivery. Intervention components that are experimental and vary by condition are the sets of behavior change strategies which will be combined with the physical activity protocol and the physical activity monitor. Condition 1 has no specific behavior change strategies; Condition 2 includes an intervention component comprised of 5 interpersonal behavior change strategies, such as facilitating social support and social comparison; Condition 3 includes an intervention component comprised of 5 intrapersonal behavior change strategies, such as setting personally meaningful goals; and Condition 4 includes both sets of behavior change strategies -- 5 interpersonal strategies combined with 5 intrapersonal behavior change strategies.
详细描述
To fully examine the effects of these experimental components, The investigators have delineated Primary, Secondary and Exploratory Aims:
Primary Aim: Determine which experimental intervention component(s) increase PA among community-dwelling older adults post-intervention: immediately, 6 months, and 12 months. Hypothesis: Participants receiving the interpersonal set of behavior change strategies (conditions 2 and 4) will have clinically meaningful increases in PA post- intervention (at all 3 time-points), compared to participants not receiving these strategies (conditions 1 and 3).
Secondary Aim: Determine which experimental intervention component(s)decrease fall occurrence and increase quality of life (QOL) among community-dwelling older adults 12 months post-intervention. Hypotheses: Participants receiving the set of interpersonal behavior change strategies will have clinically meaningful reductions in falls and increases in QOL, 12 months post-intervention, compared to participants not receiving these strategies.
Exploratory Aim: Evaluate experimental intervention component effects on targeted psychosocial constructs (social support; readiness; self-regulation) and physical constructs (functional leg strength and balance), which are theorized as mechanisms of change--and whether these mechanisms mediate the effects of experimental intervention components on PA and falls. Hypotheses: Receiving the interpersonal behavioral change strategies, relative to not receiving these strategies, will elicit increases in targeted psychosocial constructs and increases in physical constructs, which in turn will mediate the intervention's effects on PA behavior and falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The specific content of the intervention condition/arm that is assigned to each participant will be masked from data collectors/outcome assessors.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥70 years of age
- •English speaking
- •Low levels of PA (below recommended guidelines)
- •Self-reported fall risk as guided by the CDC, Steadi fall risk screener
- •One or more falls in the last year
- •Unsteadiness when standing or walking
- •Worries about falling
- •Participants who self-report the following symptoms will require clearance from a primary provider (as guided by the Exercise and Screening for You Questionnaire)
- •Pain, tightness or pressure in chest during PA (walking, climbing stairs, household chores, similar activities) that have not been checked and/ or treated by a healthcare provider
- •Current dizziness that have not been checked and/ or treated by a healthcare provider
- •Current, frequent falls that have not been checked and/ or treated by a healthcare provider
排除标准
- •Lower extremity injury or surgery within the past 6 weeks
- •Inability to walk
- •Formal diagnosis of neurocognitive impairment or dementia
结局指标
主要结局
Quantity of Physical Activity Measured Objectively
时间窗: Baseline and Post-Intervention (one week, six months, twelve months)
Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)
Physical Activity Scale for the Elderly (PASE)
时间窗: Baseline and Post-Intervention (one week, six months, twelve months)
Self-report Measure of Physical Activity. PASE is a validated questionnaire to measure the amount of physical activity in people over the age of 65 including types (e.g., walking, recreational, exercise, housework, care-giving). Scores, accounting for frequency, duration and intensity of physical activity are calculated and typically range from 0 to 793, with higher value representing more physical activity.
次要结局
- Fall Rate(12 months post intervention)
- Number of Participants With Moderate or Major Injuries From Falls(12 months post intervention)
- Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health(Baseline and post-intervention: one-week, six months, and 12 months)