Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

NCT ID: NCT02911805

Last Updated: 2025-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2028-01-28

Brief Summary

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This study will determine whether blood biomarker changes predict sight-saving benefits of exercise.

Detailed Description

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Investigators of the Atlanta VA Center for Visual and Neurocognitive Rehabilitation (CVNR) find a very high prevalence of blinding diseases in the aging Veteran population. There are few treatments for the disorders that threaten our Veterans' eyesight. The work proposed here is the first step in determining whether exercise can be used by aging Veterans as an inexpensive and self-controlled therapy for vision loss. In order to translate exercise therapy for vision into the clinic, the investigators need to identify biomarkers that can be used to predict visual benefits.

Though human and animal studies show that aerobic exercise is beneficial to specific central and peripheral nervous system functions, effects on the retina and vision were unknown until the investigators recently discovered that treadmill exercise directly protects retinal neurons in mice undergoing light-induced retinal degeneration (LIRD). The investigators found that exercise increased levels of brain-derived neurotrophic factor (BDNF) a blood protein in the blood, brain and eyes, whereas treatment of mice with a BDNF inhibitor prevented the protective effects of exercise.

For this study, the investigators will assess visual outcomes and serum biomarkers (e.g, BDNF) in 60 subjects age 18-89 before, during, and after aerobic exercise. Subjects currently enrolled in a 12-week study (under Institutional Review Board (IRB) 56726) examining the effects of aerobic exercise on cognition will have visual testing (ERG, visual acuity, contrast sensitivity, and OCT) and blood collection prior to, during and after the standardized 12-week aerobic exercise regimen to determine whether circulating biomarker levels and visual outcomes are correlated and whether biomarker levels are altered as predicted in animal studies.

This study will determine whether biomarker changes predict sight-saving benefits of exercise. As opposed to surgery or pharmacological treatments, exercise programs provide a means for Veterans to exert some control over their visual disease progression and will increase their overall health.

Conditions

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Vision Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobic Exercise

Exercise 3 times a week

Group Type ACTIVE_COMPARATOR

Aerobic exercise

Intervention Type BEHAVIORAL

Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes

Balance Training

Group balance training 3 times a week

Group Type PLACEBO_COMPARATOR

Balance exercise

Intervention Type BEHAVIORAL

Instructor-led exercises done in a group setting for strengthening, balance, flexibility

Interventions

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Aerobic exercise

Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes

Intervention Type BEHAVIORAL

Balance exercise

Instructor-led exercises done in a group setting for strengthening, balance, flexibility

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* English speaking
* Aged 18 to 89
* Sedentary as defined by \< 120 min/week of aerobic exercise over prior 3 months
* Non-demented (MMSE 24)

Exclusion Criteria

* Severe diabetes requiring insulin
* Cognitive-executive function deficit (MoCA \< 26)
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey H. Boatright, PhD

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Medical and Rehab Center, Decatur, GA

Locations

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Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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C1924-P

Identifier Type: -

Identifier Source: org_study_id

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