NCT06896825: I-PASS

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

Recruiting now NA Last updated 5 May 2026

What this trial tests

NA trial testing Self-monitoring in Healthy in 86 participants. Currently enrolling.

Timeline

23 June 2025

Primary endpoint
1 December 2026

1 January 2027

Quick facts

Lead sponsor	Arizona State University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	86
Start date	23 June 2025
Primary completion	1 December 2026
Estimated completion	1 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Self-monitoring

Conditions studied

• Healthy — all drugs for Healthy →
• Subjective Cognitive Decline (SCD) — all drugs for Subjective Cognitive Decline (SCD) →
• Sedentary Behavior — all drugs for Sedentary Behavior →
• Social Isolation in Older Adults — all drugs for Social Isolation in Older Adults →

Sponsor

Arizona State University

Who can join

60 and older, any sex, with Healthy or Subjective Cognitive Decline (SCD). Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in accelerometer-measured moderate to vigorous physical activity
  Time frame: One week at baseline and one week after intervention concludes
  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
  Time frame: Reported at baseline and after the 3 month intervention
  Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.