Healthy, Sedentary Behavior, Social Isolation in Older Adults, Subjective Cognitive Decline (SCD)
Conditions
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 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.
Interventions
BEHAVIORALSelf-monitoring
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.
Sponsors
Arizona State University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity as measured by average daily steps (and minutes of moderate to vigorous physical activity) from baseline to 3-months | 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. |
| Change in self-reported physical activity | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Stress Resilience | 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. |
| Self-reported stress | 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. |
| Brief Resilience Scale | 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. |
| Social Isolation | 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. |
| Self-reported loneliness | 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. |
| Depression | 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. |
| General Anxiety | 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. |
| Health-related quality of life | 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. |
Countries
United States
Contacts
CONTACTMolly Maxfield, PhD
CONTACTRodney Joseph, PhD
PRINCIPAL_INVESTIGATORMolly Maxfield
Arizona State University
Outcome results
None listed