Active AMD Study to Improve Function in Veterans

Conditions

• Age Related Macular Degeneration (AMD)

Eligibility Criteria

Sex

ALL

Age

65 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• SPIN — BEHAVIORAL
  Stationary cycling
• Non-aerobic, stretching/balance intervention Control — BEHAVIORAL
  Balance and stretching exercise

Study Details

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.

Key Dates

Start date

Mar 1, 2024

Status verified

Feb 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

contrast sensitivity [ Time Frame: Change from Baseline contrast sensitivity at 6 months ]

Central Contacts

• Joe R Nocera, PhD
  (404) 321-6111
  [email protected]
• Medina O Bello
  (404) 321-6111
  [email protected]

Locations (1)

Find similar trials in Decatur, GA

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• ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study
  PHASE2 · Enrolling By Invitation · Gyroscope Therapeutics Limited · Poway, California