Gerofit Exercise for Cognitive Impairment

Recruiting at 1 trial location

Overseen By Cathy C Lee, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Angina, Substance abuse, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 Participants Needed

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Gerofit Exercise Program for cognitive impairment?

Research shows that exercise programs, including aerobic and resistance exercises, can be effective for older adults with cognitive impairment. A meta-analysis found that combining physical and cognitive exercises can improve cognitive function in people with mild cognitive impairment or dementia. ^{1 2 3 4 5}

Is the Gerofit Exercise Program safe for humans?

The research does not provide specific safety data for the Gerofit Exercise Program, but exercise programs for older adults with cognitive impairment, like those studied, generally focus on improving strength and reducing risks like falls, suggesting they are designed with safety in mind. ^{6 7 8 9 10}

How is the Gerofit treatment different from other treatments for cognitive impairment?

Gerofit is unique because it is an exercise program specifically designed for older veterans, focusing on maintaining physical function and potentially enhancing cognitive function through regular physical activity. Unlike other treatments that may involve medication or virtual reality, Gerofit emphasizes group-based exercise, which can be delivered in-person or via telehealth, making it adaptable and accessible. ^{11 12 13 14 15}

Research Team

Stacy Wilkins, PhD

Principal Investigator

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

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

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Gerofit exercise Active Control 1 Intervention

Participants enrolled in the Gerofit program

Group II: Health education Placebo Group 1 Intervention

Participants enrolled in monthly in-person health education sessions which do not include a physical activity/exercise promotion session

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

Approved in United States as Gerofit for:

• Improvement of physical function and cognitive function in older veterans

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A two-month home-based exercise program for 14 older adults with cognitive impairment showed high adherence rates (94% for aerobic and 96% for resistance training) and no adverse events, indicating that such interventions are safe and feasible.

While there were trends suggesting improvements in delayed recall and significant effects on physical performance and body composition, further research is needed to fully assess the efficacy of these exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and efficacy of the home-based exercise programs in patients with cognitive impairment: A pilot study. Huang, X., Zhang, S., Li, B., et al.[2022]

Elderly individuals often face diminished exercise tolerance, which can lead to increased dependency on others for daily activities, highlighting the importance of maintaining physical fitness.

Nurse practitioners (NPs) play a vital role in motivating and educating older adults to engage in personalized fitness programs tailored to their individual health needs and preferences, promoting longer, healthier, and more active lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise programs for fitness and health for geriatrics. Johnson, CR.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a randomized controlled trial involving 82 long-term care residents with Alzheimer's disease, an activity-specific exercise program significantly improved participants' ability to perform transfers compared to a walking program and an attention control group, which both showed declines.

This study suggests that targeted exercise interventions can enhance basic mobility skills in individuals with Alzheimer's disease, highlighting the potential for tailored physical activity to support functional independence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an activity specific exercise program for individuals with Alzheimer disease in long-term care settings. Roach, KE., Tappen, RM., Kirk-Sanchez, N., et al.[2021]

A meta-analysis of 10 randomized controlled trials found that combined cognitive and physical exercise interventions have a small-to-medium positive effect on global cognitive function in older adults with mild cognitive impairment (MCI) or dementia, with an effect size of 0.32.

These interventions also significantly improve activities of daily living (ADL) with a moderate-to-large effect size of 0.65, highlighting their clinical relevance in enhancing both cognitive function and daily living skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Karssemeijer, EGA., Aaronson, JA., Bossers, WJ., et al.[2022]

A 16-week home-based multimodal exercise program significantly improved frailty in older adults with Alzheimer's dementia, as measured by the Edmonton Frail Scale and the FRAIL questionnaire, with statistical significance (P ≤ .001).

Participants in the exercise group showed a favorable transition in frailty classification compared to the control group, which experienced worsening frailty, highlighting the potential of home-based physical interventions as effective routine care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of reducing frailty components in older adults with Alzheimer's dementia: a randomized controlled home-based exercise trial (AD-HOMEX). Cezar, NOC., Aprahamian, I., Ansai, JH., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical inactivity in older adults with cognitive impairment without dementia: room for improvement. Miller, MJ., Cenzer, I., Barnes, DE., et al.[2023]

A systematic review of five randomized controlled trials involving 2,878 older adults found no significant evidence that long-term exercise reduces the risk of developing dementia, mild cognitive impairment (MCI), or other cognitive declines.

Despite lower incidence rates of dementia in exercisers (3.7%) compared to controls (6.1%), the overall results did not show a statistically significant protective effect of exercise on cognitive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Preventing Dementia, Mild Cognitive Impairment, and Clinically Meaningful Cognitive Decline: A Systematic Review and Meta-analysis. de Souto Barreto, P., Demougeot, L., Vellas, B., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A 16-week home-based multimodal exercise program significantly improved muscle strength and reduced the risk of falls in older adults with mild to moderate Alzheimer's disease, as shown by better performance on the 5X Sit-to-Stand Test and lower fall risk scores.

In contrast, the control group experienced worsening functional limitations and an increased risk of falls, highlighting the effectiveness of the exercise intervention in maintaining and enhancing physical capabilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of improving strength and functioning and decreasing the risk of falls in older adults with Alzheimer's dementia: a randomized controlled home-based exercise trial. Cezar, NOC., Ansai, JH., Oliveira, MPB., et al.[2021]

The Gerofit program, established in 1986 for older veterans, shows that a structured exercise and health promotion program can lead to significant functional improvements in older adults.

These benefits from the exercise program are not only immediate but can be maintained for up to 5 years, highlighting the long-term efficacy of regular physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gerofit Program: a VA innovation. Morey, MC., Crowley, GM., Robbins, MS., et al.[2004]

The Vivifrail exercise program significantly improved functional capacity in older adults with mild cognitive impairment or mild dementia, showing an increase of 1.40 points on the Short Physical Performance Battery after 3 months compared to usual care.

Participants in the exercise group also experienced notable improvements in cognitive function, muscle strength, and mood after 3 months, indicating that this intervention is both effective and safe for enhancing overall well-being in frail older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. Casas-Herrero, Á., Sáez de Asteasu, ML., Antón-Rodrigo, I., et al.[2023]

The Gerofit facility-based exercise program successfully transitioned to a telehealth format during COVID-19, allowing 27% of participating Veterans to continue exercising remotely.

Remote physical performance testing indicated that participants were able to retain their physical function, suggesting that telehealth exercise programs can effectively mitigate health risks associated with decreased mobility in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Transition to Telehealth Group Exercise and Functional Assessments in Response to COVID-19. Jennings, SC., Manning, KM., Bettger, JP., et al.[2021]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

In a study of 113 older adults with Mild Cognitive Impairment (MCI), a 7-month combined physical-cognitive training program significantly improved cognitive status compared to those who did not receive training.

The training also increased cerebral blood flow in the parahippocampal area, suggesting a positive impact on brain health, while no significant effect on gray matter volume loss was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. [2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

The feasibility and efficacy of the home-based exercise programs in patients with cognitive impairment: A pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Exercise programs for fitness and health for geriatrics. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an activity specific exercise program for individuals with Alzheimer disease in long-term care settings. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility of reducing frailty components in older adults with Alzheimer's dementia: a randomized controlled home-based exercise trial (AD-HOMEX). [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Physical inactivity in older adults with cognitive impairment without dementia: room for improvement. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise Training for Preventing Dementia, Mild Cognitive Impairment, and Clinically Meaningful Cognitive Decline: A Systematic Review and Meta-analysis. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Enhancing Cognition in Older Adults with Mild Cognitive Impairment through High-Intensity Functional Training: A Single-Blind Randomized Controlled Trial. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of improving strength and functioning and decreasing the risk of falls in older adults with Alzheimer's dementia: a randomized controlled home-based exercise trial. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

The Gerofit Program: a VA innovation. [2004]

12. Germany pubmed.ncbi.nlm.nih.gov

Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Rapid Transition to Telehealth Group Exercise and Functional Assessments in Response to COVID-19. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study. [2018]