Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

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

Study Overview

• Status: Active, not recruiting
• Conditions: Vision Disorders
• Intervention / Treatment: Behavioral: Aerobic exercise; Behavioral: Balance exercise

Detailed Description

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 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033-4004
      • Atlanta VA Medical and Rehab Center, Decatur, GA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic Exercise; Exercise 3 times a week	Behavioral: Aerobic exercise; Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes
Placebo Comparator: Balance Training; Group balance training 3 times a week	Behavioral: Balance exercise; Instructor-led exercises done in a group setting for strengthening, balance, flexibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Early Treatment Diabetic Retinopathy Study (ETDRS) chart	12 weeks
serum BDNF	Blood will be drawn prior to and after exercise sessions. From this, serum levels of brain derived neurotrophic factor (BDNF) will measured by immunoenzymatic assay.	12 weeks
Retinal morphology	Scanning laser ophthalmoscopy/optical coherence tomography (SLO/OCT)	12 weeks
Contrast sensitivity	CSV1000E Contrast Chart	12 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jeffrey H. Boatright, PhD, Atlanta VA Medical and Rehab Center, Decatur, GA

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2015
• Primary Completion (Actual): June 14, 2022
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Neurosciences; Brain-Derived Neurotrophic Factor; Ophthalmology; Molecular Biology; Retinal Degeneration; Neuropharmacology; Biometry; Immunochemistry
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders
• Other Study ID Numbers: C1924-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No