Exercise Intervention for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

Overseen by Joe R. Nocera, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Non-amd visual impairments, psychiatric, cardiovascular, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Age Related Macular Degeneration (AMD) is the leading cause of vision loss among Veterans aged 50 years and older. AMD also adversely affects mortality, physical and cognitive functioning, and activities of daily living. These debilitations negatively impact quality of life for US Veterans. Unfortunately, there are no cures and few treatments. With the increase in the aging Veteran population and the increasing prevalence of AMD, it is imperative to identify and implement strategies to limit the functional burden of AMD. To address this growing challenge, the investigators propose to test the impact of a proven exercise intervention, stationary bicycling (spinning), on visual and non-visual negative health outcomes in AMD. The work in several retinal degeneration mouse models shows that aerobic exercise significantly preserves retinal morphology and function and visual acuity. Even more exciting, the investigators' preliminary work with older Veterans with and without AMD suggests that spin cycling modestly but significantly benefits visual acuity in aged Veterans. Based on this work, the investigators propose to implement a 6-month synchronous, online group spin cycling program for Veterans with AMD, evaluating effects on physical, cognitive, and visual outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for age-related macular degeneration?

Research suggests that physical activity, like stationary bicycling or spinning, may help reduce the risk or slow the progression of age-related macular degeneration (AMD). Several studies have explored the positive impact of regular exercise on AMD, indicating that staying active could be beneficial for eye health.

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Is exercise safe for people with age-related macular degeneration?

The research does not specifically address the safety of exercise for age-related macular degeneration, but physical activity is generally considered safe for most people. Always consult with a healthcare provider before starting any new exercise program, especially if you have existing health conditions.

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How does the SPIN treatment for age-related macular degeneration differ from other treatments?

The SPIN treatment for age-related macular degeneration is unique because it involves physical exercise, specifically stationary bicycling or spin cycling, which is a low-cost and non-invasive approach. Unlike traditional treatments that may involve expensive drugs or surgeries, this method leverages the potential protective effects of exercise on the retina and overall eye health.

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Eligibility Criteria

This trial is for US Veterans aged 65-89 with intermediate stage Age-Related Macular Degeneration (AMD) in at least one eye. They must be cognitively intact, free from major diseases affecting exercise ability or brain function, not have severe psychiatric disorders or substance abuse issues, and must have stable internet access.

Inclusion Criteria

Participants quantified > 26 on the Montreal Cognitive Assessment (MoCA) to meet the criteria for cognitively intact

I am a veteran aged 65-89 with intermediate AMD in one eye and can participate in assessments.

I don't have any diseases that affect my thinking, heart, liver, kidney, or brain.

Exclusion Criteria

I have a history of heart disease or heart attack.

Individuals with current alcohol or substance use disorder

Other, non-AMD, visual impairments

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month synchronous, online group spin cycling program or a non-aerobic stretching/balance intervention

6 months

3 sessions per week

Midpoint Assessment

Assessment of visual, physical, and cognitive outcomes at the midpoint of the intervention

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests the effects of a 6-month online group spin cycling program on physical, cognitive, and visual outcomes in Veterans with AMD. It aims to see if this aerobic exercise can improve vision loss caused by AMD as well as enhance overall quality of life.

Group I: SPIN Experimental Treatment 1 Intervention

Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session

Group II: Non-aerobic, stretching/balance intervention Control Active Control 1 Intervention

For this arm of the intervention, randomized participants followed the same guidelines as the SPIN group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the SPIN group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Atlanta VA Medical and Rehab Center, Decatur, GA Decatur, GA

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

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

Low Light Exposure and Physical Activity in Older Adults With and Without Age-Related Macular Degeneration. [2022] To investigate the extent of low light exposure and associated physical activity in older adults with and without age-related macular degeneration (AMD).

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

Physical Activity, Incidence, and Progression of Age-Related Macular Degeneration: A Multicohort Study. [2022] To investigate the impact of physical activity (PA) on the incidence or progression of age-related macular degeneration (AMD) in the general population.

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

Physical activity and the 15-year incidence of age-related macular degeneration. [2022] There is uncertainty in the published literature as to whether physical activity should be advocated for age-related macular degeneration (AMD) prevention. We aimed to assess prospectively the association between physical activity and the 15-year incidence of AMD in older adults.

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

Prospective study of incident age-related macular degeneration in relation to vigorous physical activity during a 7-year follow-up. [2021] To test whether the risk of age-related macular degeneration (AMD) decreases with vigorous physical activity.

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

Past physical activity and age-related macular degeneration: the Melbourne Collaborative Cohort Study. [2017] To assess the association between past physical activity and early, intermediate and late age-related macular degeneration (AMD) in a community-based cohort study in Melbourne, Australia.

6. Denmark pubmed.ncbi.nlm.nih.gov

Physical activity patterns in patients with early and late age-related macular degeneration. [2022] Age-related macular degeneration (AMD) leads to visual impairment that affects visual functioning and thereby the ability to be physically active. We investigated physical activity patterns in patients with AMD.

7. Netherlands pubmed.ncbi.nlm.nih.gov

Potential Role of Exercise in Retinal Health. [2017] For many patients suffering vision loss due to retinal degeneration, the potential exists for therapeutic intervention to halt or delay disease progression. Proposed molecular, pharmacological, and surgical treatments are expensive and complicated. Finding low-cost interventions to sustain vision and thereby quality of life is vitally important. This chapter reviews findings from animal model and human subject studies indicating that physical exercise has direct, beneficial effects on regions of the central nervous system and is protective against neurodegenerative disease, including recent data from animal models showing similar effects for retina and vision. Potential local and systemic mechanistic pathways for exercise-induced retinal neuroprotection are discussed.