Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

Vision Disorders Clinical Trial

Official title:

Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02911805
• Other study ID #: C1924-P
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 10, 2015
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 31, 2024
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Vision Disorders

Intervention

Behavioral:
• Aerobic exercise
Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes
• Balance exercise
Instructor-led exercises done in a group setting for strengthening, balance, flexibility

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Early Treatment Diabetic Retinopathy Study (ETDRS) chart	12 weeks
Primary	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
Primary	Retinal morphology	Scanning laser ophthalmoscopy/optical coherence tomography (SLO/OCT)	12 weeks
Primary	Contrast sensitivity	CSV1000E Contrast Chart	12 weeks