Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT02911805

Collaborator

(none)

Enrollment

Location

Arms

105.7

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vision Disorders	Behavioral: Aerobic exercise Behavioral: Balance exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

Actual Study Start Date :

Jun 10, 2015

Actual Primary Completion Date :

Jun 14, 2022

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual acuity [12 weeks]
Early Treatment Diabetic Retinopathy Study (ETDRS) chart
serum BDNF [12 weeks]
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.
Retinal morphology [12 weeks]
Scanning laser ophthalmoscopy/optical coherence tomography (SLO/OCT)
Contrast sensitivity [12 weeks]
CSV1000E Contrast Chart