Clinical trial NCT03058146: Independent Walking for Brain Health
Official title: A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Physical Activity
Aging
Keywords: Exercise
Fitness
Physical Activity
Cognitive Aging
Cerebral Blood Flow
Brain Imaging
Unsupervised Intervention
Mobile Health
Free-living exercise intervention
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2017-02-20
Enrollment: 53
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with ongoing enrollment into each arm (individual intervention)
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA) Average Per Day
timeFrame: Pre (baseline) and post (3 months)
Secondary outcomes:
measure: Cerebral Blood Flow (Hippocampal and Frontal)
timeFrame: Pre (baseline) and post (3 months)
Other outcomes:
measure: Memory Function
timeFrame: Pre (baseline) and post (3 months)
measure: Executive Function
timeFrame: Pre (baseline) and post (3 months)
measure: Cardiorespiratory Fitness
timeFrame: Pre (baseline) and post (3 months)
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Zvinka Z Zlatar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nebeker C, Zlatar ZZ. Learning From Older Adults to Promote Independent Physical Activity Using Mobile Health (mHealth). Front Public Health. 2021 Aug 12;9:703910. doi: 10.3389/fpubh.2021.703910. eCollection 2021.