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NCT Number: NCT06107842

Effect of Gerofit Exercise on Cognition in Older Veterans

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Memory composite score

    Time frame: Change from baseline at 3 months

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

  2. Executive Function composite score

    Time frame: Change from baseline at 3 months

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

  3. Total BDNF

    Time frame: Change from baseline at 3 months

    Total brain derived neurotrophic factor (BDNF) concentrations in serum

  4. Mature BDNF

    Time frame: Change from baseline at 3 months

    Mature brain derived neurotrophic factor (BDNF) concentrations in serum

  5. Memory composite score

    Time frame: Change from baseline at 12 months

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

  6. Executive Function composite score

    Time frame: Change from baseline at 12 months

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

  7. Total BDNF

    Time frame: Change from baseline at 12 months

    Total brain derived neurotrophic factor (BDNF) concentrations in serum

  8. Mature BDNF

    Time frame: Change from baseline at 12 months

    Mature brain derived neurotrophic factor (BDNF) concentrations in serum

Study contacts

Contact information is provided by the study sponsor or research team.

Cathy C Lee, MD

CONTACT

[email protected]

(310) 268-4110

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Oct 30, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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