Effect of Gerofit Exercise on Cognition in Older Veterans

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorVA Office of Research and Development

About this trial

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

This trial accepts healthy volunteers

Qualifiers

All Veterans eligible for VA Gerofit program 65 years and older

Clearance by PCP to participate in Gerofit exercise program

Disqualifiers

Inability to perform ADLs

Significant cognitive impairment

Inability to function independently without assistance

Unstable angina; proliferative diabetic retinopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gerofit exercise

    Behavioral

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

  • Health education

    Behavioral

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Gerofit exerciseActive comparator 1 intervention
Group B: Health educationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Memory composite score

HVLT-R, verbal memory and BVMT-R, visual memory

Time frame
Change from baseline at 3 months
2

Executive Function composite score

Stroop C, Trails B, Digit span backwards and sequencing from WAIS-IV, verbal fluency, FAS and animals

Time frame
Change from baseline at 3 months
3

Total BDNF

Total brain derived neurotrophic factor (BDNF) concentrations in serum

Time frame
Change from baseline at 3 months
4

Mature BDNF

Mature brain derived neurotrophic factor (BDNF) concentrations in serum

Time frame
Change from baseline at 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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