Independent Walking for Brain Health

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University of California San Diego

Status

Terminated

Conditions

Aging
Physical Activity

Treatments

Behavioral: Mobile Health Walking Condition
Behavioral: Healthy Aging Education Condition

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03058146
K23AG049906 (U.S. NIH Grant/Contract)
20153238

Details and patient eligibility

About

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 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.

Enrollment

53 patients

Sex

All

Ages

65 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 2 patient groups

Mobile Health Walking Condition
Experimental group
Description:
Physically inactive older adults in this condition 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.
Treatment:
Behavioral: Mobile Health Walking Condition
Healthy Aging Education Condition
Active Comparator group
Description:
The education control condition will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement.
Treatment:
Behavioral: Healthy Aging Education Condition

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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