Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation
Primary Purpose
Vision Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Balance exercise
Sponsored by
About this trial
This is an interventional basic science trial for Vision Disorders focused on measuring Exercise, Retinal Degeneration, Neuropharmacology, Brain-Derived Neurotrophic Factor, Biometry, Immunochemistry, Molecular Biology, Neurosciences, Ophthalmology
Eligibility Criteria
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)
Sites / Locations
- Atlanta VA Medical and Rehab Center, Decatur, GA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aerobic Exercise
Balance Training
Arm Description
Exercise 3 times a week
Group balance training 3 times a week
Outcomes
Primary Outcome Measures
Visual acuity
Early Treatment Diabetic Retinopathy Study (ETDRS) chart
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.
Retinal morphology
Scanning laser ophthalmoscopy/optical coherence tomography (SLO/OCT)
Contrast sensitivity
CSV1000E Contrast Chart
Secondary Outcome Measures
Full Information
NCT ID
NCT02911805
First Posted
September 8, 2016
Last Updated
February 23, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02911805
Brief Title
Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation
Official Title
Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2015 (Actual)
Primary Completion Date
June 14, 2022 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine whether blood biomarker changes predict sight-saving benefits of 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders
Keywords
Exercise, Retinal Degeneration, Neuropharmacology, Brain-Derived Neurotrophic Factor, Biometry, Immunochemistry, Molecular Biology, Neurosciences, Ophthalmology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise
Arm Type
Active Comparator
Arm Description
Exercise 3 times a week
Arm Title
Balance Training
Arm Type
Placebo Comparator
Arm Description
Group balance training 3 times a week
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes
Intervention Type
Behavioral
Intervention Name(s)
Balance exercise
Intervention Description
Instructor-led exercises done in a group setting for strengthening, balance, flexibility
Primary Outcome Measure Information:
Title
Visual acuity
Description
Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Time Frame
12 weeks
Title
serum BDNF
Description
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.
Time Frame
12 weeks
Title
Retinal morphology
Description
Scanning laser ophthalmoscopy/optical coherence tomography (SLO/OCT)
Time Frame
12 weeks
Title
Contrast sensitivity
Description
CSV1000E Contrast Chart
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey H. Boatright, PhD
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation
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