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Increasing Physical Activity Through Social Support and Stress Resilience

Study acronym: I-PASS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoint(s) modified
    • Primary completion pushed from Dec 2026 to Mar 2027
    • Study completion pushed from Jan 2027 to Apr 2027
    • Secondary endpoints: 13 to 8
    v7
  2. Notable Primary endpoint(s) modified
    • Eligibility criteria shortened, about 7 words
    v6
  3. Minor Primary completion pushed from Sep 2026 to Dec 2026
    • Study completion pushed from Oct 2026 to Jan 2027
    v5
  4. Minor Primary completion date: May 2026 to Sep 2026
    • Study completion date: Jul 2026 to Oct 2026
    v4
  5. Minor Eligibility criteria revisedv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2025 to Jun 23, 2025
    • Secondary endpoints: details revised at 7 of 13 entries
    • Site details revised
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06896825
Lead Sponsor Arizona State University
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)
Healthy, Subjective Cognitive Decline (SCD), Sedentary Behavior, Social Isolation in Older Adults
Related terms Sedentary Behavior
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov