COVID-19 shut down of research operations

Physical activity interventions with older adults can improve brain health; however most interventions have been performed in gym-like settings that reach a small sector of the senior population. Since not everyone can access a gym, it is important to study whether brisk walking in real world environments can also help brain health. This study will use mobile health devices to help older adults independently walk for brain health, thus representing a critical step towards the dissemination of physical activity intervention programs aimed at preserving cognitive function in aging.

Physical activity interventions conducted in supervised settings (laboratories and group settings) with older adults have consistently shown improved cardiovascular and cerebrovascular health and improved cognitive function. What is lacking is the development of interventions that take place in real world environments and that take advantage of new technologies to help objectively track real time physical activity behaviors. Real world physical activity interventions have the potential to reach a larger segment of the population and to enhance maintenance after the intervention period ends. This study will develop a novel physical activity intervention using mobile health technologies to promote physical activity levels likely to affect cerebral blood flow and cognition in real world environments in cognitively normal older adults. A randomized controlled trial will be conducted with 30 participants being assigned to the mobile health physical activity condition (walking in free-living environments tracked via mobile health technologies) and another 30 to an education control condition (at home reading about healthy aging materials) for 3 months.

Inclusion Criteria:

• Men and women between the ages of 65-80
• Ability to obtain a signed physician's clearance for participation in this study
• English-speaking as needed to complete cognitive testing and follow study procedures
• Cognitively normal (based on comprehensive neuropsychological assessment)
• No contraindications for Magnetic Resonance Imaging (MRI)
• Must be ambulatory and able to walk independently

Exclusion Criteria:

• History of head injury involving loss of consciousness within the past 6 months and/or history of severe traumatic brain injury
• Major neurological disorders (dementia, multiple sclerosis, epilepsy, etc)
• Chronic major psychiatric disorders (schizophrenia, major recurrent affective disorder)
• History of major vascular events (myocardial infarction, stroke, etc),
• History of diabetes
• History of falls in the last year resulting in hospitalization
• Unstable or poorly controlled medical problems e.g. heart failure, diabetes (poorly controlled or on insulin), uncontrolled hypertension, pulmonary disease with hypoxia or hypercapnia, significant liver problems or renal failure, treatment of cancer in the past 2 years (other than non-melanoma skin cancer), HIV positive
• Objective evidence of cognitive impairment based on neuropsychological assessment

Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate. Publication of data shall occur during and at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.

In total, 44 participants were randomized to the intervention, with 21 in the Physical Activity Condition and 23 in the Healthy Aging Education Condition. One participant who was randomized to the Healthy Aging Education Condition could not finalize the baseline measurement appointment due to the COVID-19 pandemic shutting down research operations. Therefore, the analytical sample consisted of 43 participants.

12 weeks

Adverse events recording followed the National Institute on Aging (NIA) Adverse Event and Serious Adverse Event Guidelines as outlined by the study's Data and Safety Monitoring Plan (DSMP), which included a safety officer. All adverse events were carefully monitored via telephone contact throughout the trial and were reported to the Institutional Review Board (IRB) of the University of California, San Diego, and the NIA program official following National Institutes of Health (NIH) guidelines.

Due to the COVID-19 pandemic, recruitment was terminated early, leading to a smaller than expected sample. As such, results are presented as descriptive statistics for pre and post intervention time points.