Independent Walking for Brain Health

Overview

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.

Full Title of Study: “A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2021

Detailed Description

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.

Interventions

  • Behavioral: Mobile Health Walking Condition
    • Physically inactive older adults in this condition (N=30) will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.
  • Behavioral: Healthy Aging Education Condition
    • The education control condition (N=30) will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement.

Arms, Groups and Cohorts

  • Experimental: Mobile Health Walking Condition
    • Physically inactive older adults in this condition (N=30) will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.
  • Active Comparator: Healthy Aging Education Condition
    • The education control condition (N=30) will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement.

Clinical Trial Outcome Measures

Primary Measures

  • Cerebral Blood Flow measured with arterial spin labeling MRI
    • Time Frame: 0 and 12 weeks
    • Changes in cerebral blood flow (hippocampal and frontal) measured with arterial spin labeling MRI
  • Memory Function (average of z-scores)
    • Time Frame: 0, 6 weeks, and 12 weeks
    • Memory Composite (average of z-scores) = Changes in NIH Toolbox Cognition Battery Picture Sequence Memory Test; Rey Auditory Verbal Learning Test (short and long delay free recall); Wechsler Memory Scale-R Logical Memory (immediate and delay recall).
  • Executive Function (average of z-scores)
    • Time Frame: 0, 6 weeks, 12 weeks
    • Executive Function Composite (average of z-scores) = NIH Toolbox Cognition Battery Flanker Inhibitory Control and Attention Test; List Sorting Working Memory Test; Dimensional Change Card Sort Test
  • Cardiorespiratory fitness via sub-maximal treadmill test
    • Time Frame: 0 and 12 weeks
    • Change in total time to 85% of estimated maximal heart rate
  • Physical activity via tri-axial accelerometry (ActiGraph wGT3X)
    • Time Frame: 0, 6 weeks, 12 weeks
    • Changes in moderate to vigorous levels of physical activity (defined as >1952 counts per minute)

Participating in This Clinical Trial

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
  • Physically inactive (less than 60 minutes of structured. moderate intensity physical activity in the past 6 months)
  • 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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zvinka Z. Zlatar, Assistant Adjunct Professor – University of California, San Diego
  • Overall Official(s)
    • Zvinka Z Zlatar, PhD, Principal Investigator, University of California, San Diego
  • Overall Contact(s)
    • Zvinka Z Zlatar, PhD, 858-822-7737, zzlatar@ucsd.edu

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