Active AMD Study to Improve Function in Veterans

Age Related Macular Degeneration (AMD) Clinical Trial

Official title: The Active AMD Study to Improve Function in Veterans With Age Related Macular Degeneration

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Aim 1 is to determine if exercise training preserves visual outcomes in Veterans with intermediate AMD when compared to a non-aerobic exercised, contact-controlled AMD group. Best corrected visual acuity, dark adaptometry, contrast sensitivity, optical coherence tomography angiography (OCT-A) and the Low Luminance Questionnaire will be assessed before, mid, and after the 6-month interventional period. In line with previous animal and human subject studies, the investigators also hypothesize a correlation between improved visual function with increases in serum brain derived neurotrophic factor (BDNF). Aim 2 is to determine if exercise improves physical and cognitive function in Veterans with AMD when compared to non-aerobic exercised, contact-controlled AMD group. The investigators will test the timed-up-and-go (TUG) and a neuropsychological battery, mid- and post 6-month interventional period. These provide a robust index of other health, well-being, and quality of life related outcomes in numerous older adult patient populations. In line with the preliminary studies, the investigators' working hypothesis is that 6 months of exercise will result in a clinically significant improvement in TUG performance as well as improved cognitive-executive functions. The investigators expect that the results from achieving these aims will set the stage for a larger, multi-site trial powered to test the hypothesis that virtual exercise can slow the progression of AMD while improving physical and cognitive function and quality of life in Veterans. Thus, the investigators propose an accessible, low-cost intervention that can be easily scalable to other VA centers to improve engagement/adherence, while also improving visual and functional capacity for Veterans with AMD who are at high risk for comorbidities. ;

Related Conditions & MeSH terms

• Age Related Macular Degeneration (AMD)
• Macular Degeneration

• NCT number: NCT05932069
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Joe R Nocera, PhD
• Phone: (404) 321-6111
• Email: joenocera@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Completion date: August 31, 2028