Increasing Physical Activity Through Social Support and Stress Resilience (I-PASS) Among Older Adults Living Alone With SCD to Lower ADRD Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months
研究概览
简要总结
The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience.
The primary questions are to determine whether
- the tech-enhanced condition lead to greater physical activity over time?
- the tech-enhanced condition lead to social support and stress resilience over time?
- social support and stress resilience mediate the relationship between the study condition and physical activity?
All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience.
Participants will:
- Use a Garmin wearable device to monitor their physical activity
- Be randomly assigned to a basic education condition or tech-enhanced condition
- Set achievable goals for weekly physical activity, with incremental increases to achieve 7000 average daily steps by the end of the study
- Respond to surveys to monitor their social support, stress resilience, quality of life, and depression.
The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 60 years or older
- •Living alone and community dwelling
- •Engaging in 60 minutes or less per week of self-reported moderate-to-vigorous physical activity at screening (based on Exercise Vital Sign Questionnaire)
- •Self-reported decline in cognitive functioning
- •Self-reported ownership of/willingness to use a smartphone with an iOS or Android operating system (necessary for participants to track their activity using a wearable activity monitor).
- •Able to read and speak in English. We hope to offer the intervention in Spanish in the future; however, currently, the study materials are only available in English, and participation will require ability to read and respond to study materials.
排除标准
- •Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a physician's note is provided
- •Resting blood pressure greater than 200/110 mmHG as assessed at the baseline study assessment (unless a physician's note is provided)
- •Plans to relocate out of metropolitan Phoenix, Arizona area in the next 6 months
- •Participation in another physical activity, nutrition or weight loss program at time of screening or at any time during the intervention
- •Individuals with mild cognitive impairment (MCI), as determined by either a self-report of receiving a diagnosis of MCI from a health care provider or as assessed by the Telephone-Montreal Cognitive Assessment (T-MoCA) at the Baseline Session. A score < 18 is an exclusion criterion.
- •Individuals with neurodegenerative (e.g., dementia), developmental (e.g., autism), neurologic (e.g., Parkinson's, epilepsy), or major psychiatric (e.g., bipolar, schizophrenia) diagnoses
- •Being previously prescribed one of the 5 approved Alzheimer's medications, including: Donepezil (Aricept), Rivastigmine (Exelon), Galantamine (Razadyne), Memantine (Namenda), Memantine + Donepezil (Namzaric)
- •Score of 9 or higher on the 15-item Geriatric Depression Scale (GDS) at the Baseline Session [scores of 9 and higher are indicative of moderate to severe depression]
- •History of stroke
- •Incarcerated individuals (i.e., Prisoners)
研究组 & 干预措施
Tech-enhanced condition
Participants in the tech-enhanced condition will receive access to a study specific website (to be developed into an app) and guided use via individual coaching sessions delivered on Zoom. Coaching sessions will align with and reinforce website content, which includes information about the importance of and strategies to increase physical activity, social support, and stress resilience.
干预措施: Self-monitoring (Behavioral)
Control condition
Participants in the control condition will receive a study-specific manual containing basic education about the importance of and strategies to increase physical activity, social support, and stress resilience.
干预措施: Self-monitoring (Behavioral)
结局指标
主要结局
Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months
时间窗: Assessed at baseline and 3-months
ActiGraph GT9X Link Activity monitors worn on non-dominant wrist during waking hours 7 consecutive days will provide objective measure of 1) average daily steps and 2) moderate to vigorous activity prior to and after the intervention. GTX9X data (collected in raw format) will be aggregated for analysis to epochs of 60 secs or less for comparability to other studies.
Change in self-reported physical activity
时间窗: Assessed at baseline and 3-months
Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.
次要结局
- Self-reported stress(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Brief Resilience Scale(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Self-reported loneliness(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Social Isolation(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Depression(Assessed at screening and after the 3 month intervention)
- Objective Stress Resilience(Assessed at baseline and 3-months)
- General Anxiety(Assessed at baseline and after the 3 month intervention)
- Health-related quality of life(Assessed at baseline and after the 3 month intervention)
- Objective Stress Resilience(Assessed at baseline and after the 3 month intervention)
- Self-reported stress(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Brief Resilience Scale(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Social Isolation(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Self-reported loneliness(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Objective cognitive functioning: Visual memory(Assessed at baseline and after the 3 month intervention)
- Objective cognitive functioning: Executive functioning(Assessed at baseline and after the 3 month intervention)
- Objective cognitive functioning: Processing Speed 1(Assessed at baseline and after the 3 month intervention)
- Objective cognitive functioning: Processing Speed 2(Assessed at baseline and after the 3 month intervention)
- Depression(Assessed at screening and after the 3 month intervention)
- General Anxiety(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
- Health-related quality of life(Assessed at baseline, end of month 1, end of month 2, and end of month 3)
研究者
Molly Maxfield
Associate Professor
Arizona State University