Gerofit and Cognition

NCT06107842 | Recruiting DMC

• 1 other identifier: E4521-R
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Aging; Cognitive Impairment; Physical Activity

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Gerofit exercise

ACTIVE COMPARATOR

Participants enrolled in the Gerofit program

Behavioral: Gerofit exercise

Health education

PLACEBO COMPARATOR

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

Behavioral: Health education

Interventions

Gerofit exercise BEHAVIORAL

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

Gerofit exercise

Health education BEHAVIORAL

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

Health education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

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

West Los Angeles, California, 90073-1003, United States

RECRUITING

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

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy C Lee, MD

CONTACT

(310) 268-4110; cathy.lee2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Gerofit intervention vs Health Education Control
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: randomized controlled study

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 30, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)