Independent Walking for Brain Health

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2020-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Regular Exercise on Cerebrovascular Reserve in Older Adults

NCT03158337

Aging Physical Activity Cognitive Function

RECRUITING NA

Double-task Exercise in Older Adults at Risk of Cognitive Decline (MeMo-Health-Cog-3 Program)

NCT04068376

Cognitive Decline Vascular Health

ACTIVE_NOT_RECRUITING NA

The Entorhinal Cortex and Aerobic Exercise in Aging

NCT02775760

Aging

TERMINATED NA

Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease

NCT06038643

Physical Inactivity

COMPLETED NA

Daily Activity Study of Health: Increasing Physical Activity in Aging

NCT04315363

Aging

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Activity Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial with ongoing enrollment into each arm (individual intervention)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Mobile Health Walking Condition

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Healthy Aging Education Condition

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes