Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05932069

Conditions

Age Related Macular Degeneration (AMD)

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

SPIN

Non-aerobic, stretching/balance intervention Control

Study Details

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)

Study ID

NCT05932069

Start date

Mar 1, 2024

Status verified date

Feb, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SPIN

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

active comparator: Non-aerobic, stretching/balance intervention Control

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

Interventions

SPIN

Stationary cycling

Non-aerobic, stretching/balance intervention Control

Balance and stretching exercise

Primary outcome measure

  • contrast sensitivity [ Time Frame: Change from Baseline contrast sensitivity at 6 months ]
  • Dark adaptometry [ Time Frame: Change from Baseline dark adaptometry at 6 months ]

Central Contacts and Locations

Central contacts

Joe R Nocera, PhD

(404) 321-6111joenocera@emory.edu

Medina O Bello

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

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Joe R Nocera, PhD

404-321-6111joenocera@emory.edu

Principal Investigator:

Joe R. Nocera, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Age Related Macular Degeneration (AMD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-23.