Study Stopped
COVID-19 shut down of research operations
Independent Walking for Brain Health
A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition
2 other identifiers
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 20, 2017
CompletedStudy Start
First participant enrolled
October 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2020
CompletedResults Posted
Study results publicly available
July 17, 2023
CompletedJuly 17, 2023
July 1, 2023
2.6 years
February 10, 2017
February 23, 2023
July 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Moderate to Vigorous Physical Activity (MVPA) Average Per Day
Average minutes per day spent in moderate to vigorous levels of physical activity (MVPA) (defined as =\>1952 accelerometer counts per minute). MVPA minutes were determined based on one-week of accelerometer wear on the hip at baseline and post intervention.
Pre (baseline) and post (3 months)
Secondary Outcomes (1)
Cerebral Blood Flow (Hippocampal and Frontal)
Pre (baseline) and post (3 months)
Other Outcomes (3)
Memory Function
Pre (baseline) and post (3 months)
Executive Function
Pre (baseline) and post (3 months)
Cardiorespiratory Fitness
Pre (baseline) and post (3 months)
Study Arms (2)
Mobile Health Walking Condition
EXPERIMENTALPhysically 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.
Healthy Aging Education Condition
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- National Institutes of Health (NIH)collaborator
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of California, San Diego
La Jolla, California, 92093, United States
Related Publications (2)
Hays Weeks CC, Moore AA, Allison M, Patrick K, Bondi MW, Nebeker C, Liu TT, Wing D, Higgins M, Hartman SJ, Rissman RA, Zlatar ZZ. The Independent Walking for Brain Health Intervention for Older Adults: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e42980. doi: 10.2196/42980.
PMID: 36535765DERIVEDNebeker 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.
PMID: 34476229DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to the COVID-19 pandemic, recruitment was terminated early, leading to a smaller than expected sample. As such, results are presented as descriptive statistics for pre and post intervention time points.
Results Point of Contact
- Title
- Dr. Zvinka Zlatar
- Organization
- University of California, San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Zvinka Z Zlatar, PhD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 20, 2017
Study Start
October 12, 2017
Primary Completion
May 18, 2020
Study Completion
May 20, 2020
Last Updated
July 17, 2023
Results First Posted
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
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.