Exercise Intervention for Age-Related Macular Degeneration

Overseen By Medina O Bello

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

70 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 3 5 7}

Research Team

Joe R. Nocera, PhD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

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

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

Treatment Details

Interventions

• Control
• SPIN

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

In a study of 28 older adults (14 with age-related macular degeneration and 14 normally sighted), both groups experienced similar levels of low light exposure and physical activity during waking hours, indicating that AMD does not significantly affect these factors.

However, those with AMD had more brief active periods during sleep, and reduced physical activity in low light was linked to lower scores on the Low Luminance Questionnaire, highlighting the need for better lighting in environments for older adults to enhance safety and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Light Exposure and Physical Activity in Older Adults With and Without Age-Related Macular Degeneration. Dev, MK., Black, AA., Cuda, D., et al.[2022]

High levels of physical activity (PA) are associated with a reduced risk of developing early age-related macular degeneration (AMD), based on a meta-analysis of 14,630 adults from 7 studies.

Conversely, low to moderate levels of PA increase the risk of incident early AMD, highlighting the importance of maintaining an active lifestyle as a modifiable risk factor for AMD prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity, Incidence, and Progression of Age-Related Macular Degeneration: A Multicohort Study. Mauschitz, MM., Schmitz, MT., Verzijden, T., et al.[2022]

In a study of older adults, those aged 75 and above who were the most physically active showed a 79% lower likelihood of developing late age-related macular degeneration (AMD) over 15 years, but this association lost significance after adjusting for other health factors.

Overall, the research concluded that physical activity does not have a significant impact on the risk of developing AMD in older adults when considering factors like diet, smoking, and body mass index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and the 15-year incidence of age-related macular degeneration. Gopinath, B., Liew, G., Burlutsky, G., et al.[2022]

A study of 41,708 runners over 7.7 years found that those who engaged in more vigorous physical activity, specifically running, had a significantly lower risk of developing age-related macular degeneration (AMD).

For every additional kilometer run per day, the risk of AMD decreased by 10%, with those running 2 to 4 km/d having a 19% lower risk and those running 4 km/d or more having a 42% to 54% lower risk, regardless of other factors like diet and smoking.

NCBI (Pubmed)

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. Williams, PT.[2021]

In a study of 20,816 participants, no overall association was found between past recreational physical activity and the development of age-related macular degeneration (AMD).

However, women who engaged in vigorous exercise three or more times a week had a 22% lower odds of developing intermediate AMD, suggesting a potential protective effect of frequent vigorous exercise specifically in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Past physical activity and age-related macular degeneration: the Melbourne Collaborative Cohort Study. McGuinness, MB., Karahalios, A., Simpson, JA., et al.[2017]

In a study of 198 participants, including 103 with late age-related macular degeneration (AMD), it was found that lower visual acuity was linked to reduced engagement in physically demanding activities and fewer daily steps.

Despite vision loss, patients with late AMD can remain physically active, although they tend to shift towards less demanding activities that require less sharp central vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity patterns in patients with early and late age-related macular degeneration. Subhi, Y., Sørensen, TL.[2022]

Physical exercise has been shown to have direct, beneficial effects on the central nervous system and can protect against neurodegenerative diseases, including those affecting vision, based on studies in both animal models and human subjects.

Exercise may provide a low-cost intervention to sustain vision and improve quality of life for patients with retinal degeneration, with potential local and systemic mechanisms contributing to retinal neuroprotection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Role of Exercise in Retinal Health. Pardue, MT., Chrenek, MA., Schmidt, RH., et al.[2017]

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]

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

Physical Activity, Incidence, and Progression of Age-Related Macular Degeneration: A Multicohort Study. [2022]

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

Physical activity and the 15-year incidence of age-related macular degeneration. [2022]

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]

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

Past physical activity and age-related macular degeneration: the Melbourne Collaborative Cohort Study. [2017]

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

Physical activity patterns in patients with early and late age-related macular degeneration. [2022]

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

Potential Role of Exercise in Retinal Health. [2017]