Independent Walking for Brain Health

• ClinicalTrials.gov Identifier: NCT03058146
• Recruitment Status: Terminated
• First Posted: February 20, 2017
• Last Update Posted: September 2, 2022
• Sponsor: University of California, San Diego
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Information provided by (Responsible Party): Zvinka Z. Zlatar, University of California, San Diego

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 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: Treatment
• Official Title: A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition
• Actual Study Start Date: June 7, 2017
• Actual Primary Completion Date: March 15, 2020
• Actual Study Completion Date: March 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Moderate to Vigorous Physical Activity [ Time Frame: 0, 6 weeks, 12 weeks ]
   Change in moderate to vigorous levels of physical activity (defined as >1952 accelerometer counts per minute)

Secondary Outcome Measures :

1. Cerebral Blood Flow (hippocampal and frontal) [ Time Frame: 0 and 12 weeks ]
   Change in cerebral blood flow measured with arterial spin labeling MRI

Other Outcome Measures:

1. Memory Function [ Time Frame: 0, 6 weeks, and 12 weeks ]
   Memory Composite (average of z-scores) = Rey Auditory Verbal Learning Test (short and long delay free recall); Wechsler Memory Scale-R Logical Memory (immediate and delay recall).
2. Executive Function [ Time Frame: 0, 6 weeks, 12 weeks ]
   Executive Function Composite (average of z-scores) = Trail Making Test Part B minus Trail Making Test Part A, Stroop Color Word Trial, and verbal fluency (letters FAS).
3. Cardiorespiratory Fitness [ Time Frame: 0 and 12 weeks ]
   Change in total time to 85% of estimated maximal heart rate via sub-maximal treadmill test

Eligibility Criteria

• 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
• 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

Contacts and Locations

Locations

United States, California

University of California, San Diego

La Jolla, California, United States, 92093

Sponsors and Collaborators

University of California, San Diego

National Institutes of Health (NIH)

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Zvinka Z Zlatar, PhD; University of California, San Diego

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Zvinka Z. Zlatar, Assistant Adjunct Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03058146
• Other Study ID Numbers: 20153238; K23AG049906 ( U.S. NIH Grant/Contract )
• First Posted: February 20, 2017
• Last Update Posted: September 2, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• 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