AgingNCT06107842
Effect of Gerofit Exercise on Cognition in Older Veterans
A study testing Gerofit exercise and Health education in people with Aging and Cognitive Impairment, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Impairment, Physical Activity
- What is being tested?
- Gerofit exercise and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2024to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All Veterans eligible for VA Gerofit program 65 years and older
- Clearance by PCP to participate in Gerofit exercise program
Who cannot join
- 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
Show all 11Show fewer
- Incontinence
- Open wounds
- Volatile behavioral issue or unable to work successfully in a group environment/setting
- Active substance abuse
- Homelessness
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Rhianna Patel, 443-421-5833, rhianna.patel@va.gov
Steven J Prior, PhD, 3014052483, steven.prior@va.gov
- Recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Irma Gvilia, PhD MS, (818) 891-7711 ext. 38024, Irma.Gvilia@va.gov
Cathy C Lee, MD
About this study
Official title: Relationship of Exercise Frequency, Intensity, and Fitness to Improved Cognition and Biomarkers in Gerofit Participants
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.
- Conditions
- Aging, Cognitive Impairment, Physical Activity
- Being tested
- Gerofit exercise, Health education
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gerofit exerciseBehavioural
Individualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week
Health educationBehavioural
Scheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session
| Study group | Role | What they receive |
|---|---|---|
| Gerofit exercise | Active comparator | Participants enrolled in the Gerofit program Receives: Behavioral: Gerofit exercise |
| Health education | Placebo comparator | Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory composite score
HVLT-R, verbal memory and BVMT-R, visual memory
Measured: 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
Measured: Change from baseline at 3 months
Total BDNF
Total brain derived neurotrophic factor (BDNF) concentrations in serum
Measured: Change from baseline at 3 months
Mature BDNF
Mature brain derived neurotrophic factor (BDNF) concentrations in serum
Measured: Change from baseline at 3 months
Memory composite score
HVLT-R, verbal memory and BVMT-R, visual memory
Measured: 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
Measured: Change from baseline at 12 months
Total BDNF
Total brain derived neurotrophic factor (BDNF) concentrations in serum
Measured: Change from baseline at 12 months
Mature BDNF
Mature brain derived neurotrophic factor (BDNF) concentrations in serum
Measured: Change from baseline at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Apr 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Cathy C Lee, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAJonathan M Wanagat, MD PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAStacy Wilkins, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107842
- Sponsor's protocol ID
- E4521-R
- Status last verified
- May 2026
- First submitted
- 25 Oct 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Exercise Frequency, Intensity, and Fitness to Improved Cognition and Biomarkers in Gerofit Participants
- ClinicalTrials.gov ID
- NCT06107842
- Acronym / sponsor ID
- E4521-R
- Conditions
- Aging, Cognitive Impairment, Physical Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Gerofit exercise | Active comparator | Behavioral: Gerofit exerciseParticipants enrolled in the Gerofit program |
| Health education | Placebo comparator | Behavioral: Health educationParticipants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- All Veterans eligible for VA Gerofit program 65 years and older
- Clearance by PCP to participate in Gerofit exercise program
Key exclusion criteria (11 listed)
- Inability to perform ADLs
- Significant cognitive impairment
- Inability to function independently without assistance
- Unstable angina; proliferative diabetic retinopathy
- Oxygen dependent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gerofit exerciseIndividualized exercise prescription as well as a group exercise class based on physical function assessments offered 3x/week | Behavioural | Gerofit exercise |
| Health educationScheduled monthly in-person health education discussion sessions covering 12 different health topics not including a physical activity/exercise promotion session | Behavioural | Health education |
Primary outcome
Memory composite score
Time frame: Change from baseline at 3 months
HVLT-R, verbal memory and BVMT-R, visual memory
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
Total BDNF
Time frame: Change from baseline at 3 months
Total brain derived neurotrophic factor (BDNF) concentrations in serum
Mature BDNF
Time frame: Change from baseline at 3 months
Mature brain derived neurotrophic factor (BDNF) concentrations in serum
Memory composite score
Time frame: Change from baseline at 12 months
HVLT-R, verbal memory and BVMT-R, visual memory
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
Total BDNF
Time frame: Change from baseline at 12 months
Total brain derived neurotrophic factor (BDNF) concentrations in serum
Mature BDNF
Time frame: Change from baseline at 12 months
Mature brain derived neurotrophic factor (BDNF) concentrations in serum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cathy C Lee, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Jonathan M Wanagat, MD PhD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Stacy Wilkins, PhD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gerofit exercise and Health education in people with Aging and Cognitive Impairment, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy C Lee, MD ((310) 268-4110, cathy.lee2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory composite score (time frame: Change from baseline at 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.