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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stationary biking (spin cycling) might benefit people with age-related macular degeneration (AMD), a condition that causes vision loss and affects daily life. The study compares two groups: one engaging in spin cycling and another performing non-aerobic exercises like stretching and balance activities. The researchers aim to determine if biking can improve not only vision but also physical and cognitive health. Veterans with intermediate-stage AMD in at least one eye, who can exercise and have stable internet at home, are well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for those with AMD.

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 prior data suggests that this exercise intervention is safe for Veterans with AMD?

Research has shown that physical activities like stationary biking are usually safe for most people. Studies indicate that increased physical activity can reduce the risk of developing early-stage age-related macular degeneration (AMD), a common eye condition. Staying active is linked to better eye health overall.

The SiFAr program demonstrates that cycling can be safe for older adults. This program helps improve cycling skills, making biking a safe option even for those who feel they need more practice.

While exercise is generally safe, consulting a healthcare provider is advisable to ensure it suits individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPIN exercise intervention for age-related macular degeneration (AMD) because it explores a non-pharmacological approach to potentially slow the progression of this eye condition. Unlike typical treatments such as anti-VEGF injections, which target blood vessel growth in the eye, SPIN involves aerobic exercise on a stationary bike to possibly improve overall vascular health and eye function. This method aims to harness the benefits of regular physical activity, which is not only accessible and low-cost but also free from the side effects often associated with medication. By focusing on exercise, researchers hope to find a complementary or alternative strategy for managing AMD.

What evidence suggests that spin cycling might be an effective treatment for AMD?

Research shows that being very physically active can reduce the risk of developing early age-related macular degeneration (AMD), a condition that affects vision. Animal studies indicate that aerobic exercise, such as spin cycling, helps maintain the eye's structure and function, which is crucial for clear vision. Early research with older Veterans found that spin cycling can slightly but noticeably improve vision. In this trial, participants in the SPIN arm will engage in aerobic exercise through stationary bicycling. Exercise also links to better outcomes in eye conditions, including AMD. These findings suggest that the exercise program under study might help manage some negative effects of AMD on vision and overall health. ^{1 4 6 7 8}

Who Is on the Research Team?

Joe R. Nocera, PhD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Are You a Good Fit for This Trial?

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

Participants required to have stable internet access in their home

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/exercise-intervention-for-age-related-macular-degeneration-f9d59

Exercise Intervention for Age-Related Macular Degeneration 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 ...

2. digitalcommons.library.uab.edu digitalcommons.library.uab.edu/cgi/viewcontent.cgi?article=2110&context=etd-collection

How Older Adults With Age-Related Macular Degeneration Living In ... Results of this study indicate that the only variable. Page 47. 31 significantly related to exercise change was self-efficacy (β = .20. p<0.05). Age and (OR.

3. link.springer.com link.springer.com/article/10.1007/s11357-024-01208-x

Effects of voluntary and forced physical exercise on the ... Among these, ocular conditions such as age-related macular degeneration (AMD) ... Exercise reverses age-related vulnerability of the retina ...

4. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2125742

Prospective Study of Incident Age-Related Macular ... - IOVS To test whether the risk of age-related macular degeneration (AMD) decreases with vigorous physical activity. methods. This was a prospective study of self- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9988706/

Physical Activity Is Associated With Macular Thickness ... age-related macular degeneration, and diabetic retinopathy.–7 Furthermore, exercise has been associated with improved patient outcomes in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28549846/

Physical Activity and Age-related Macular Degeneration Purpose: To better understand the association, in a white population, of physical activity and age-related macular degeneration (AMD)-the main cause of ...

7. aao.org aao.org/eyenet/article/physical-activity-and-amd-risk

Physical Activity and AMD Risk ... and age-related macular degeneration (AMD). They found that a more active lifestyle was independently associated with lower odds of both the ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36882759/

Safer cycling in older age (SiFAr): effects of a multi- ... The SiFAr program increases cycling skills among older adults with self-perceived needs for improvement in CC and could easily be made available to a broad ...