Independent Walking for Brain Health

Aging Clinical Trial

Official title:

A Novel Mobile Health Exercise Intervention in Aging: Brain Perfusion and Cognition

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03058146
• Other study ID #: 20153238
• Secondary ID: K23AG049906
• Status: Terminated
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: May 20, 2020

Study information

• Verified date: July 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: May 20, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Memory Function	A memory composite score was created by converting raw scores into z-scores and then averaging them for the following tests: Rey Auditory Verbal Learning Test trials 1 to 5, trial 6 (short-delay free recall), and delayed recall; Wechsler Memory Scale - Revised Logical Memory I and II (immediate and delayed recall scores). Z-scores were calculated using raw scores for these tests in the entire sample [(raw score-mean of the sample)/standard deviation of the sample]. Z-scores of 0 represent the sample's mean performance on the tests, z-scores >0 indicate better performance compared to the sample's mean, while z-scores <0 indicate worse performance compared to the sample's mean.	Pre (baseline) and post (3 months)
Other	Executive Function	An executive function composite score was created by converting raw scores into z-scores and then averaging them for the following tests: Trail Making Test Part B minus Trail Making Test Part A, Golden version of the Stroop Color Word Trial, and verbal fluency (letters F,A,S). Trail making test scores were reversed prior to averaging, so higher scores = better performance. Z-scores were calculated using raw scores for these tests in the entire sample [(raw score-mean of the sample)/standard deviation of the sample]. Z-scores of 0 represent the sample's mean performance on the tests, z-scores >0 indicate better performance compared to the sample's mean, while z-scores <0 indicate worse performance compared to the sample's mean.	Pre (baseline) and post (3 months)
Other	Cardiorespiratory Fitness	Total time it takes the participant to reach 85% of their estimated maximal heart rate (220-age) measured via sub-maximal treadmill test in seconds.	Pre (baseline) and post (3 months)
Primary	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	Cerebral Blood Flow (Hippocampal and Frontal)	Average cerebral blood flow measured with arterial spin labeling magnetic resonance imaging in ml/100g/min. Cerebral blood flow was obtained via arterial spin labeling MRI and Freesurfer software was utilized to delineate regions of interest for each participant (right and left regions were averaged). For the frontal lobe cerebral blood flow we averaged the mean of superior frontal, rostral and caudal middle frontal, pars opercularis, pars triangularis, pars orbitalis, lateral and medial orbitofrontal, precentral, paracentral, and frontal pole.	Pre (baseline) and post (3 months)