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NCT Number: NCT06896825

Increasing Physical Activity Through Social Support and Stress Resilience

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

Location status: Recruiting

Location contact

Molly Maxfield

PRINCIPAL_INVESTIGATOR

Molly Maxfield, PhD

CONTACT

[email protected]

602-496-2311

Rodney Joseph

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 < 18 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]
  • History of stroke
  • Incarcerated individuals (i.e., Prisoners)

Treatment and study plan

Self-monitoring

Behavioral

All 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.

Primary outcomes

  1. Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months

    Time frame: Assessed at baseline and 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.

  2. Change in self-reported physical activity

    Time frame: Assessed at baseline and 3-months

    Participants will complete an abbreviated 7-Day Physical Activity Recall interview, which assesses self-reported moderate to vigorous physical activity.

Secondary outcomes

  1. Objective Stress Resilience

    Time frame: Assessed at baseline and 3-months

    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.

  2. Self-reported stress

    Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3

    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.

  3. Brief Resilience Scale

    Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3

    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.

  4. Social Isolation

    Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3

    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.

  5. Self-reported loneliness

    Time frame: Assessed at baseline, end of month 1, end of month 2, and end of month 3

    The 3-item UCLA Loneliness scale assesses the feeling of being alone or lacking companionship. Responses range from 1 to 3. Sum scores are calculated. Possible scores range from a minimum of 3 to a maximum of 9. Higher numbers indicate greater perceived loneliness.

  6. Depression

    Time frame: Assessed at screening and after the 3 month intervention

    Participants will complete the 15-item Geriatric Depression Scale. The items include yes/no responses. Scores will be summed. Possible scores range from a minimum value of 0 to a maximum value of 15. Higher scores indicate greater depression. At eligibility screening, participants must score below 9 on this measure to be included in the study.

  7. General Anxiety

    Time frame: Assessed at baseline and after the 3 month intervention

    Participants will complete the 7-item General Anxiety Disorder Questionnaire. Using a 4 point scale (0 to 3), the items assess worry and anxiety over the past two weeks. Mean scores will be calculated. Possible scores range from a minimum score of 0 to a maximum score of 21. Higher scores indicate greater anxiety.

  8. Health-related quality of life

    Time frame: Assessed at baseline and after the 3 month intervention

    Participants will complete the 4-item health-related quality of life assessment. The items assess self-perceived health and days during the past month they had poor physical health or mental health, and the extent to which poor health kept them from doing daily activities. Mean scores will be calculated. Higher scores indicate poorer health-related quality of life.

Other outcomes

  1. Cognitive Health

    Time frame: Assessed during online eligibility screening and after the 3 month intervention

    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.

  2. Change in Garmin-assessed physical activity

    Time frame: From enrollment to the end of treatment at 3 months

    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.

  3. Subjective Cognitive Decline

    Time frame: Assessed at baseline and after the 3 month intervention

    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.

  4. Objective cognitive functioning: Processing Speed 2

    Time frame: Assessed at baseline and after the 3 month intervention

    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.

  5. Objective cognitive functioning: Processing Speed 1

    Time frame: Assessed at baseline and after the 3 month intervention

    Participants will complete two tasks assessing processing speed. The first requires visual processing of patterns in two pictures, detecting similarities and differences as quickly as possible without making mistakes. This is the Pattern Comparison 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.

  6. Objective cognitive functioning: Executive functioning

    Time frame: Assessed at baseline and after the 3 month intervention

    Participants will complete an executive functioning task requiring set-shifting, or the ability to switch back and forth between multiple aspects of a strategy or task. This is the Dimensional Change Card Sort 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.

  7. Objective cognitive functioning: Verbal memory

    Time frame: Assessed at baseline and after the 3 month intervention

    Participants will complete a verbal memory task in which they hear a series of words read and are asked to recall as many as they can immediately after the list; this process is completed three times total to assess both learning and memory. Ten to 15 minutes later, they are asked to recall as many words as possible. This is the Auditory Verbal Learning Test 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.

  8. Objective cognitive functioning: Visual memory

    Time frame: Assessed at baseline and after the 3 month intervention

    Participants will complete a visual memory task in which they see a series of pictures in a specified order. Immediately after, they are tasked with placing the pictures in the correct order. This is the Picture Sequence Memory Test 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.

  9. Protocol Adherence

    Time frame: Assessed after the 3 month intervention is complete

    To assess protocol adherence, we will calculate number of days the Garmin is worn (all participants), the number of weeks participants met their physical activity goal (all participants), and the number of coaching sessions attended (participants in the tech enhanced group only). Higher numbers for each indicate greater levels of adherence to the protocol.

  10. Treatment Acceptance

    Time frame: Assessed after the 3 month intervention is complete

    To assess overall acceptability of the intervention, participants will complete a treatment acceptance survey specifically adapted for this study. This survey will include satisfaction and acceptability ratings, as well as open-ended questions to obtain participant feedback. Total scores are not calculated. This data will be used to improve the intervention for future studies.

Study contacts

Contact information is provided by the study sponsor or research team.

Molly Maxfield, PhD

CONTACT

[email protected]

602-496-2311

Rodney Joseph, PhD

CONTACT

[email protected]

602-496-0772

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: I-PASS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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