Gerofit and Cognition

NCT ID: NCT06107842

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2029-03-31

Brief Summary

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Over 50% of the Veterans enrolled for VA health care are over the age of 65. Dementia prevalence increases with age, and with the increase in the population of people ages 65 and older, the total number of people with dementia is also increasing. Older Veterans often have comorbid PTSD, major depression and traumatic brain injury so that they are at 2 to 5 times the risk for cognitive impairment and dementia compared to the general population. There is evidence that exercise interventions in sedentary older adults could improve both physical and cognitive function. However, there have been very few studies on the effects of exercise on cognition in older Veterans and do not reflect the broader ethnic and health-status diversity of Veterans. Thus, improved knowledge of the role of exercise on cognition as well as the predictive power of biomarkers could have a major beneficial impact on Veterans' functional independence and quality of life. The investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans and that blood and muscle biomarkers will predict these improvements.

Detailed Description

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Conditions

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Aging Cognitive Impairment Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Gerofit intervention vs Health Education Control

Study Groups

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Gerofit exercise

Participants enrolled in the Gerofit program

Group Type ACTIVE_COMPARATOR

Gerofit exercise

Intervention Type BEHAVIORAL

Individualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week

Health education

Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session

Group Type PLACEBO_COMPARATOR

Health education

Intervention Type BEHAVIORAL

Scheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session

Interventions

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Gerofit exercise

Individualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week

Intervention Type BEHAVIORAL

Health education

Scheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All Veterans eligible for VA Gerofit program 65 years and older
* Clearance by PCP to participate in Gerofit exercise program

Exclusion Criteria

* Inability to perform ADLs
* Significant cognitive impairment
* Inability to function independently without assistance
* Unstable angina; proliferative diabetic retinopathy
* Oxygen dependent
* Unwillingly to commute and/or not able to provide own transportation to Gerofit
* Incontinence
* Open wounds
* Volatile behavioral issue or unable to work successfully in a group environment/setting
* Active substance abuse
* Homelessness
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cathy C Lee, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Jonathan M Wanagat, MD PhD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Stacy Wilkins, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Locations

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VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Site Status RECRUITING

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cathy C Lee, MD

Role: CONTACT

(310) 268-4110

Facility Contacts

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Irma Gvilia, PhD MS

Role: primary

818-891-7711 ext. 38024

Rhianna Patel

Role: primary

443-421-5833

Steven J Prior, PhD

Role: backup

3014052483

Other Identifiers

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E4521-R

Identifier Type: -

Identifier Source: org_study_id

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