Clinical trial NCT06896825: Increasing Physical Activity Through Social Support and Stress Resilience
Official title: Increasing Physical Activity Through Social Support and Stress Resilience (I-PASS) Among Older Adults Living Alone With SCD to Lower ADRD Risk
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Subjective Cognitive Decline (SCD)
Sedentary Behavior
Social Isolation in Older Adults
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-03-26
Enrollment: 86
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 150 minutes per week 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: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 \< 19 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 \[scores of 9 and higher are indicative of moderate to severe depression\]
* Currently taking 2 or more anti-depression medications
* History of stroke
* Incarcerated individuals (i.e., Prisoners)

Primary outcomes:
measure: Change in accelerometer-measured moderate to vigorous physical activity
timeFrame: One week at baseline and one week after intervention concludes
measure: Change in Garmin-assessed physical activity
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change in self-reported physical activity
timeFrame: Reported at baseline and after the 3 month intervention
Secondary outcomes:
measure: Objective Stress Resilience
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Self-reported stress
timeFrame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
measure: Brief Resilience Scale
timeFrame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
measure: Social Isolation
timeFrame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
measure: Self-reported loneliness
timeFrame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
measure: Objective cognitive functioning: Visual memory
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Objective cognitive functioning: Verbal memory
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Objective cognitive functioning: Executive functioning
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Objective cognitive functioning: Processing Speed 1
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Objective cognitive functioning: Processing Speed 2
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Depression
timeFrame: Assessed at screening and after the 3 month intervention
measure: General Anxiety
timeFrame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
measure: Health-related quality of life
timeFrame: Assessed at baseline, end of month 1, end of month 2, and end of month 3
Other outcomes:
measure: Cognitive Health
timeFrame: Assessed during online eligibility screening and after the 3 month intervention
measure: Functional Activities
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Physical Activity Readiness
timeFrame: Assessed at screening and after the 3 month intervention
measure: Subjective Cognitive Decline - Eligibility
timeFrame: Assessed at screening and after the 3 month intervention
measure: Subjective Cognitive Decline
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Health Status and History
timeFrame: Assessed at baseline and after the 3 month intervention
measure: Demographic information
timeFrame: Assessed at baseline
measure: Family History of Alzheimer's disease and related dementias
timeFrame: Assessed at baseline
measure: Protocol Adherence
timeFrame: Assessed after the 3 month intervention is complete
measure: Treatment Acceptance
timeFrame: Assessed after the 3 month intervention is complete
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Molly Maxfield
role: PRINCIPAL_INVESTIGATOR
References: