Clinical trial NCT06107842: Gerofit and Cognition
Official title: Relationship of Exercise Frequency, Intensity, and Fitness to Improved Cognition and Biomarkers in Gerofit Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Cognitive Impairment
Physical Activity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Memory composite score
timeFrame: Change from baseline at 3 months
measure: Executive Function composite score
timeFrame: Change from baseline at 3 months
measure: Total BDNF
timeFrame: Change from baseline at 3 months
measure: Mature BDNF
timeFrame: Change from baseline at 3 months
measure: Memory composite score
timeFrame: Change from baseline at 12 months
measure: Executive Function composite score
timeFrame: Change from baseline at 12 months
measure: Total BDNF
timeFrame: Change from baseline at 12 months
measure: Mature BDNF
timeFrame: Change from baseline at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Cathy C Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Jonathan M Wanagat, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Stacy Wilkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: