Effect of Gerofit Exercise on Cognition in Older Veterans

Relationship of Exercise Frequency, Intensity, and Fitness to Improved Cognition and Biomarkers in Gerofit Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity; Cognitive Impairment; Aging
• Intervention / Treatment: Behavioral: Gerofit exercise; Behavioral: Health education

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cathy C Lee, MD; Phone Number: (310) 268-4110; Email: cathy.lee2@va.gov

Study Locations

• United States
  • California
    • West Los Angeles, California, United States, 90073-1003
      • Recruiting
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
      • Contact: Irma Gvilia, PhD MS; Phone Number: 38024 (818) 891-7711; Email: Irma.Gvilia@va.gov
      • Principal Investigator: Cathy C Lee, MD
      • Principal Investigator: Jonathan M Wanagat, MD PhD
      • Principal Investigator: Stacy Wilkins, PhD
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
      • Contact: Rhianna Patel; Phone Number: 443-421-5833; Email: rhianna.patel@va.gov
      • Contact: Steven J Prior, PhD; Phone Number: 3014052483; Email: steven.prior@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gerofit exercise; Participants enrolled in the Gerofit program	Behavioral: Gerofit exercise; Individualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week
Placebo Comparator: Health education; Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session	Behavioral: Health education; Scheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory composite score	HVLT-R, verbal memory and BVMT-R, visual memory	Change from baseline at 3 months
Executive Function composite score	Stroop C, Trails B, Digit span backwards and sequencing from WAIS-IV, verbal fluency, FAS and animals	Change from baseline at 3 months
Total BDNF	Total brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 3 months
Mature BDNF	Mature brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 3 months
Memory composite score	HVLT-R, verbal memory and BVMT-R, visual memory	Change from baseline at 12 months
Executive Function composite score	Stroop C, Trails B, Digit span backwards and sequencing from WAIS-IV, verbal fluency, FAS and animals	Change from baseline at 12 months
Total BDNF	Total brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 12 months
Mature BDNF	Mature brain derived neurotrophic factor (BDNF) concentrations in serum	Change from baseline at 12 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Cathy C Lee, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA; Principal Investigator: Jonathan M Wanagat, MD PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA; Principal Investigator: Stacy Wilkins, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Behavior; Cognitive Dysfunction; Motor Activity
• Other Study ID Numbers: E4521-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No