Clinical Trial

Increasing Physical Activity Through Social Support and Stress Resilience

Study acronym: I-PASS
Recruiting
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Summary
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.
Protocol Amendment History 6 changes
critical Primary endpoint(s) modified 2026-06-30
notable Primary completion pushed: 2026-12 -> 2027-03 2026-06-30
minor Completion pushed: 2027-01 -> 2027-04 2026-06-30
critical Primary endpoint(s) modified 2026-05-08
notable Primary completion pushed: 2026-09 -> 2026-12 2026-04-28
minor Completion pushed: 2026-10 -> 2027-01 2026-04-28
Trial Details
NCT Number NCT06896825
Lead Sponsor Arizona State University
Collaborators: National Institute on Aging (NIA)
Conditions Healthy, Subjective Cognitive Decline (SCD), Sedentary Behavior, Social Isolation in Older Adults
Enrollment 86 participants
Start Date 2025-06-23
Primary Completion 2027-03 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-29