Gerofit and Cognition

Study Overview
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Brief Summary
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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.

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

Conditions
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Aging, Cognitive Impairment, Physical Activity

Intervention / Treatment
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* Behavioral: Gerofit exercise
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled study
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |