About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Self-monitoring
BehavioralAll 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 average daily steps was selected based on recent findings that it is associated with clinically meaningful health outcomes and being an achievable target for most adults.
Treatment groups
Trial outcomes
Primary outcomes
Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 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
Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.
Secondary outcomes
Objective Stress Resilience
At baseline and 3 months, participants will have blood drawn to assess glial fibrillary acidic protein, an indicator of stress which has also been associated with neurocognitive disorders.
Self-reported stress
The 14-item Perceived Stress Scale, with items rated on a 5 point scale (0 to 4). Sum scores are calculated. Possible values range from minimum of 0 to maximum of 56. Higher scores indicate greater perceived stress.
Brief Resilience Scale
The 6-item Brief Resilience Scale assesses ability to recover from or adjust to challenges. Items are rated on a 5 point scale. Mean scores are calculated. Possible scores range from a minimum of 1 to a maximum of 5. Higher scores indicating greater resilience.
Social Isolation
The 10-item Lubben Social Network Scale assesses objective size of social network. Items are rated on a 6 point scale. Sum scores are calculated. Possible scores range from a minimum of 0 and maximum of 60. Higher scores indicate larger social network and contacts.
Other outcomes
Cognitive Health
To establish eligibility, participants will complete the Telephone administered Montreal Cognitive Assessment (T-MoCA) during the online eligibility screening. Because we are recruiting individuals with subjective cognitive decline, we will rule out potential cognitive impairment with the T-MoCA. Scores are totaled. Possible scores range from 0 to 22. Higher scores indicating better performance. Participants scoring 17 or lower (out of 22) will be ineligible for participation. We will readminister at the end of the 3 month intervention to determine whether change occurred.
Change in Garmin-assessed physical activity
Participants agree to wear a Garmin throughout the study, offering continuous data about their physical activity. We will use average daily steps (calculated weekly, from Monday to Sunday) to assess physical activity continuously during the intervention.
Subjective Cognitive Decline
Participants will complete the 20-item Subjective Cognitive Decline questionnaire. They will rate the level of change on a 5 point scale (no change to much worse). Mean scores will be calculated, with higher scores indicating greater perceived decline in cognitive functioning.
Objective cognitive functioning: Processing Speed 2
Participants will complete two tasks assessing processing speed. The second requires matching of patterns between numbers and symbols as quickly as possible without making mistakes. This is the Oral Symbol Digit Task from the NIH Toolbox Cognitive Battery. Scoring is automatically calculated by the NIH Toolbox App and is age normed, with higher scores indicating stronger performance on the task.
Sponsors and contacts
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Arizona State University
Lead sponsor
National Institute on Aging (NIA)
Collaborator