Recruiting

Gerofit & Cognition

Sponsor:

VA Office of Research and Development

Code:

NCT06107842

Conditions

Aging

Cognitive Impairment

Physical Activity

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Gerofit exercise

Health education

Study Details

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

Study ID

NCT06107842

Start date

Apr 1, 2024

Status verified date

May, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Gerofit exercise

Participants enrolled in the Gerofit program

placebo comparator: Health education

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

Interventions

Gerofit exercise

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

Health education

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

Primary outcome measure

  • Memory composite score [ Time Frame: Change from baseline at 3 months ]
  • Executive Function composite score [ Time Frame: Change from baseline at 3 months ]
  • Total BDNF [ Time Frame: Change from baseline at 3 months ]
  • Mature BDNF [ Time Frame: Change from baseline at 3 months ]
  • Memory composite score [ Time Frame: Change from baseline at 12 months ]
  • Executive Function composite score [ Time Frame: Change from baseline at 12 months ]
  • Total BDNF [ Time Frame: Change from baseline at 12 months ]
  • Mature BDNF [ Time Frame: Change from baseline at 12 months ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

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

Contacts

Principal Investigator:

Cathy C Lee, MD

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

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-02.