Increasing Physical Activity Through Social Support and Stress Resilience

Официальное название

Increasing Physical Activity Through Social Support and Stress Resilience (I-PASS) Among Older Adults Living Alone With SCD to Lower ADRD Risk

Обзор

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.

Вмешательства

• Поведенческое Self-monitoring
  All participants will receive a Garmin and use the associated app to monitor their weekly physical activity. Enrolled participants are insufficiently active (engaging in 60 minutes or less of moderate to vigorous physical activity per week) and will receive weekly text messages to incrementally increase physical activity over the course of the study. Goals will be 20% greater than the average daily steps from the previous week, with the ultimate goal of reaching 7000 average daily steps. 7000 av

Первичные конечные точки

• Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months [Срок оценки: Assessed at baseline and 3-months]
• Change in self-reported physical activity [Срок оценки: Assessed at baseline and 3-months]

Вторичные конечные точки (8)

• Objective Stress Resilience [Срок оценки: Assessed at baseline and 3-months]
• Self-reported stress [Срок оценки: Assessed at baseline, end of month 1, end of month 2, and end of month 3]
• Brief Resilience Scale [Срок оценки: Assessed at baseline, end of month 1, end of month 2, and end of month 3]
• Social Isolation [Срок оценки: Assessed at baseline, end of month 1, end of month 2, and end of month 3]
• Self-reported loneliness [Срок оценки: Assessed at baseline, end of month 1, end of month 2, and end of month 3]
• Depression [Срок оценки: Assessed at screening and after the 3 month intervention]
• General Anxiety [Срок оценки: Assessed at baseline and after the 3 month intervention]
• Health-related quality of life [Срок оценки: Assessed at baseline and after the 3 month intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Arizona State University — Phoenix

Идентификаторы

NCT: NCT06896825 · STUDY00020326 · 1P30AG086561-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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