Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

NCT02911805 | Active Not Recruiting Results

• 1 other identifier: C1924-P
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vision Disorders

Keywords

Exercise; Retinal Degeneration; Neuropharmacology; Brain-Derived Neurotrophic Factor; Biometry; Immunochemistry; Molecular Biology; Neurosciences; Ophthalmology

Outcome Measures

Primary Outcomes (1)

• Visual Acuity - Mean Acuity Change

  Early Treatment Diabetic Retinopathy Study (ETDRS) chart was used. Higher scores mean a better outcome. The number of correct responses (e.g., number of letters read correctly) from a subject assessed prior to start of the first session of the the 12 week study was subtracted from the number of correct responses elicited at the end of the last session of the study. The means of these differences for each study group (Balance Training vs Aerobic Exercise) were compared by two-tailed t-test.

  12 weeks

Secondary Outcomes (2)

• Contrast Sensitivity

  12 weeks

• Concentration of Brain-Derived Neurotrophic Factor (BDNF) in Serum.

  12 weeks

Study Arms (2)

Aerobic Exercise

ACTIVE COMPARATOR

Exercise 3 times a week

Behavioral: Aerobic exercise

Balance Training

PLACEBO COMPARATOR

Group balance training 3 times a week

Behavioral: Balance exercise

Interventions

Aerobic exercise BEHAVIORAL

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

Aerobic Exercise

Balance exercise BEHAVIORAL

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

Balance Training

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe diabetes requiring insulin
• Cognitive-executive function deficit (MoCA \< 26)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

MeSH Terms

Conditions

Vision Disorders; Motor Activity; Retinal Degeneration

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Eye Diseases, Hereditary; Retinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jeffrey H. Boatright, PhD
• Organization: Atlanta VA

jeffrey.boatright@va.gov

404-321-6111

Study Officials

• Jeffrey H. Boatright, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 22, 2016
• Study Start: June 10, 2015
• Primary Completion: June 14, 2022
• Study Completion (Estimated): January 28, 2028
• Last Updated: December 5, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)