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Independent Walking for Brain Health

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ClinicalTrials.gov Identifier: NCT03058146
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Zvinka Z. Zlatar, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Physical Activity Aging Behavioral: Mobile Health Walking Condition Behavioral: Healthy Aging Education Condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial with ongoing enrollment into each arm (individual intervention)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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

  2. 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).

  3. 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

  4. Cardiorespiratory fitness via sub-maximal treadmill test [ Time Frame: 0 and 12 weeks ]
    Change in total time to 85% of estimated maximal heart rate

  5. 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)



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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058146


Contacts
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Contact: Zvinka Z Zlatar, PhD 858-822-7737 zzlatar@ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Zvinka Zlatar, PhD    858-822-7737    zzlatar@ucsd.edu   
Principal Investigator: Zvinka Z Zlatar, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Zvinka Z Zlatar, PhD University of California, San Diego

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Responsible Party: Zvinka Z. Zlatar, Assistant Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03058146     History of Changes
Other Study ID Numbers: 20153238
K23AG049906 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zvinka Z. Zlatar, University of California, San Diego:
Exercise
Fitness
Physical Activity
Cognitive Aging
Cerebral Blood Flow
Brain Imaging
Unsupervised Intervention
Mobile Health
Free-living exercise intervention