Active AMD Study to Improve Function in Veterans

NCT05932069 | Recruiting

• 2 other identifiers: C4563-R1I01RX004563
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age Related Macular Degeneration (AMD)

Keywords

Age Related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (2)

• contrast sensitivity

  1.Contrast Sensitivity (CS) will be determined using the CSV1000E Contrast Chart. This test provides for four rows ofsine-wave gratings. Subjects will view the chart from a distance of 2.5m. Subjects will view the chart monocularly while wearing their normal correction. CS thresholds will be assessed for both eyes individually.

  Change from Baseline contrast sensitivity at 6 months

• Dark adaptometry

  Dark adaptometry (primary vision outcome measure). Dark adaptation or night vision is known to be affected with increasing stages of AMD. This test probes the ability of the eye to dark adapt. Participants will be asked to place their head on a chin rest in front of the machine. Each eye will be tested individually, and the opposing eye will be covered with an eye patch. While fixating on a light at the back of the machine, a bright flash will be presented to bleach the photoreceptors and then a series of dimmer flashes will appear and the participant will be asked to identify whether or not they saw the flashes by pushing a response button. The duration of the test is \~7 minutes per eye.

  Change from Baseline dark adaptometry at 6 months

Secondary Outcomes (1)

• Best Corrected Visual Acuity

  Change from best corrected visual acuity at 6 months

Study Arms (2)

SPIN

EXPERIMENTAL

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

Behavioral: SPIN

Non-aerobic, stretching/balance intervention Control

ACTIVE COMPARATOR

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

Behavioral: Non-aerobic, stretching/balance intervention Control

Interventions

SPIN BEHAVIORAL

Stationary cycling

SPIN

Non-aerobic, stretching/balance intervention Control BEHAVIORAL

Balance and stretching exercise

Non-aerobic, stretching/balance intervention Control

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The investigators will recruit Veterans with a diagnosis of intermediate stage AMD in at least one eye, aged 65-89, willing and able to cooperate with assessments and interventions.
• Eligible participants will be quantified \> 26 on the Montreal Cognitive Assessment (MoCA) to meet the criteria for cognitively intact.
• Participants will be free from diseases affecting cognition or ability to engage in aerobic exercise (including but not limited to chronic heart, liver, or kidney disease) and from diseases/injuries directly affecting brain functions (including but not limited to significant closed head injury, open intracranial wounds, stroke, epilepsy, degenerative diseases of the nervous system).
• Eligible participants will be required to have stable internet access in their home.
• All subjects will speak English as a primary language and will have graduated high school so that behavioral/cognitive measures reflect effects of age, AMD, and/or aerobic exercise and not the effects of familiarity with English or lack of education.

You may not qualify if:

• Other, non-AMD, visual impairments. Potential participants with major psychiatric disorder (including but not limited to psychosis, major depression, bipolar disorder) by history will be excluded as well as individuals with current alcohol or substance use disorder.
• Additionally, individuals with cardiovascular disease and or history of myocardial infarction will not be included.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

Related Publications (1)

• Bello MO, Mammino KM, Vernon MA, Wakeman DG, Denmon CA, Krishnamurthy LC, Krishnamurthy V, McGregor KM, Novak TS, Nocera JR. Graded Intensity Aerobic Exercise to Improve Cerebrovascular Function and Performance in Older Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 26;13:e58316. doi: 10.2196/58316.

  PMID: 39326042 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Joe R. Nocera, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe R Nocera, PhD

CONTACT

(404) 321-6111; joenocera@emory.edu

Medina O Bello

CONTACT

(404) 321-6111; medina.bello@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: July 6, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)