150 Participants Needed

Gerofit Exercise for Cognitive Impairment

Recruiting at 1 trial location
CC
Overseen ByCathy C Lee, MD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise can improve brain function in older Veterans, particularly those with conditions like PTSD or depression. Participants will either join the Gerofit exercise program or attend health education sessions without exercise. The goal is to assess whether exercise can enhance cognitive abilities and identify any blood or muscle changes that predict improvement. Veterans aged 65 or older who can safely exercise may be suitable candidates. As an unphased trial, this study provides Veterans the opportunity to contribute to important research that could enhance cognitive health through exercise.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Gerofit exercise program is safe for older Veterans?

Research has shown that the Gerofit exercise program can enhance physical abilities in older adults. While detailed safety data specifically for Gerofit is lacking, exercise programs generally prove safe for participants. Studies on Gerofit have not reported major negative effects, suggesting its safety. Its widespread use further supports this. Participants engage in supervised exercise sessions designed to boost overall health, making it a suitable option for older adults seeking to improve physical and mental health with minimal risk.12345

Why are researchers excited about this trial?

Unlike traditional treatments for cognitive impairment, which often involve medication or cognitive training exercises, the Gerofit program stands out by focusing on physical exercise as a primary intervention. Researchers are excited about Gerofit because it leverages the potential of physical fitness to improve cognitive health, a less conventional but promising approach. This method not only aims to enhance cognitive function but also promotes overall physical well-being, providing a holistic benefit that standard cognitive treatments may not offer.

What evidence suggests that the Gerofit exercise program might be an effective treatment for cognitive impairment?

Research has shown that exercise programs like Gerofit, which participants in this trial may receive, benefit older adults with memory and thinking problems. A review of several studies found that both aerobic exercises (such as walking or cycling) and resistance exercises (such as weightlifting) can improve brain function in this group. Previous research suggests that exercise enhances brain health by increasing blood flow and encouraging the growth of new brain cells. Gerofit is designed to help older Veterans stay active, potentially leading to better memory and thinking skills. This program aims to help participants reach recommended activity levels, which are linked to improved mental sharpness and overall health.12345

Who Is on the Research Team?

CC

Cathy C Lee, MD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

JM

Jonathan M Wanagat, MD PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

SW

Stacy Wilkins, PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 65 or older who are eligible for the VA Gerofit program and have been cleared by their primary care provider to participate. It's not suitable for those unable to perform daily activities, function independently, with certain medical conditions like unstable angina or proliferative diabetic retinopathy, homelessness, significant cognitive impairment, active substance abuse, or behavioral issues in group settings.

Inclusion Criteria

I am a veteran, 65 or older, eligible for the VA Gerofit program.
Clearance by PCP to participate in Gerofit exercise program

Exclusion Criteria

You are currently using drugs or alcohol in a harmful or excessive way.
I need help with daily activities.
I have unstable chest pain.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in the Gerofit exercise program or health education sessions

12 months
Monthly in-person sessions

Follow-up

Participants are monitored for changes in cognitive function and biomarkers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Gerofit
Trial Overview The study examines whether participating in the VA Gerofit exercise program can improve cognitive function in older Veterans. It also aims to identify if blood and muscle biomarkers can predict these improvements. The intervention includes regular physical activity through the Gerofit exercise alongside health education.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Gerofit exerciseActive Control1 Intervention
Group II: Health educationPlacebo Group1 Intervention

Gerofit is already approved in United States for the following indications:

🇺🇸
Approved in United States as Gerofit for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Published Research Related to This Trial

A 3-month high-intensity intervallic functional training (HIFT) program significantly improved cognitive functions in elderly individuals with mild cognitive impairment, as evidenced by better scores in cognitive impairment, attention, verbal fluency, and concentration compared to a control group.
The study involved 132 participants aged over 65, and the results suggest that incorporating HIFT into therapeutic approaches for the elderly could be beneficial for cognitive health, particularly as it emphasizes functional training and high intensity.
Enhancing Cognition in Older Adults with Mild Cognitive Impairment through High-Intensity Functional Training: A Single-Blind Randomized Controlled Trial.Rivas-Campo, Y., Aibar-Almazán, A., Rodríguez-López, C., et al.[2023]
56% of older adults with cognitive impairment without dementia (CIND) were found to be physically inactive, with self-rated health, difficulty walking, total assets, and education level being significant predictors of inactivity.
Despite the high prevalence of inactivity, 61% of inactive participants were capable of engaging in greater moderate-vigorous physical activity (MVPA), suggesting that tailored interventions could enhance their health and cognitive outcomes.
Physical inactivity in older adults with cognitive impairment without dementia: room for improvement.Miller, MJ., Cenzer, I., Barnes, DE., et al.[2023]
The PrAISED intervention, which involved up to 50 therapy sessions focusing on exercise and functional activities for adults with early dementia or mild cognitive impairment, did not show significant improvements in daily living activities, physical activity, or quality of life compared to usual care after 12 months.
Although the intervention group experienced fewer falls (79 falls) compared to the control group (200 falls), the difference was not statistically significant, indicating that the exercise program did not effectively reduce fall risk or improve overall health outcomes.
Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial.Harwood, RH., Goldberg, SE., Brand, A., et al.[2023]

Citations

Study Details | NCT06107842 | Gerofit and CognitionThe investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans and that blood and muscle ...
Gerofit and Cognition | Clinical Research Trial Listing ...The investigators hypothesize that participation in the VA Gerofit exercise program will improve cognitive function in older Veterans.
Gerofit Exercise for Cognitive ImpairmentResearch shows that exercise programs, including aerobic and resistance exercises, can be effective for older adults with cognitive impairment. A meta-analysis ...
Physical Function Assessment of Older Veterans with ...This paper reports on a retrospective analysis of baseline data collected at enrollment in Gerofit, a national facility-based outpatient clinical exercise ...
Evaluation of the Gerofit to Home Model of Care: A Remote ...The primary goal of Gerofit exercise programs is to help older adults meet the Physical Activity Guidelines of at least 150 min of moderate to ...
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