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Behavioral Intervention
Exercise Intervention for Age-Related Macular Degeneration
N/A
Recruiting
Led By Joe R. Nocera, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from best corrected visual acuity at 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to use exercise to help Veterans with AMD improve physical, cognitive, and visual outcomes. There are no cures or treatments, so this could benefit the aging Veteran population.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for spinning exercises, participants may experience general exercise-related discomforts such as muscle soreness or fatigue. The risk of injury could also increase due to balance issues related to age and potential vision impairment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline contrast sensitivity at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline contrast sensitivity at 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dark adaptometry
contrast sensitivity
Secondary study objectives
Best Corrected Visual Acuity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SPINExperimental Treatment1 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 ControlActive Control1 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
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,713 Total Patients Enrolled
Joe R. Nocera, PhDPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
4 Previous Clinical Trials
298 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart disease or heart attack.I am a veteran aged 65-89 with intermediate AMD in one eye and can participate in assessments.I don't have any diseases that affect my thinking, heart, liver, kidney, or brain.I speak English as my first language and have finished high school.
Research Study Groups:
This trial has the following groups:- Group 1: SPIN
- Group 2: Non-aerobic, stretching/balance intervention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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