Gerofit and Cognition

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Physical Activity; Aging
• Interventions: Behavioral: Health education; Behavioral: Gerofit exercise

• Registration Number: NCT06107842
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-30
• Study Start: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2027-09-30
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health education	Health education	Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session
Gerofit exercise	Gerofit exercise	Participants enrolled in the Gerofit program

Primary Outcome Measures

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

Trial Locations

Locations (2)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA; 🇺🇸 West Los Angeles, California, United States

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States