Trial Outcomes & Findings for Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation (NCT NCT02911805)

Last Updated: 2025-12-05

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

14 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Aerobic Exercise Exercise 3 times a week Aerobic exercise: Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes	Balance Training Group balance training 3 times a week Balance exercise: Instructor-led exercises done in a group setting for strengthening, balance, flexibility
Overall Study STARTED	6	8
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bridging Animal and Human Models of Exercise-induced Visual Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerobic Exercise n=6 Participants Exercise 3 times a week Aerobic exercise: Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes	Balance Training n=8 Participants Group balance training 3 times a week Balance exercise: Instructor-led exercises done in a group setting for strengthening, balance, flexibility	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Age, Categorical >=65 years	6 Participants n=37 Participants	8 Participants n=37 Participants	14 Participants n=74 Participants
Age, Continuous	73.7 years STANDARD_DEVIATION 8.6 • n=37 Participants	73.1 years STANDARD_DEVIATION 4.0 • n=37 Participants	73.4 years STANDARD_DEVIATION 6.1 • n=74 Participants
Sex: Female, Male Female	6 Participants n=37 Participants	7 Participants n=37 Participants	13 Participants n=74 Participants
Sex: Female, Male Male	0 Participants n=37 Participants	1 Participants n=37 Participants	1 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Black or African American	3 Participants n=37 Participants	3 Participants n=37 Participants	6 Participants n=74 Participants
Race (NIH/OMB) White	2 Participants n=37 Participants	2 Participants n=37 Participants	4 Participants n=74 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	3 Participants n=37 Participants	4 Participants n=74 Participants
Region of Enrollment United States	6 Participants n=37 Participants	8 Participants n=37 Participants	14 Participants n=74 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: As per baseline analysis population description.

Outcome measures

Outcome measures
Measure	Aerobic Exercise n=6 Participants Exercise 3 times a week Aerobic exercise: Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes	Balance Training n=8 Participants Group balance training 3 times a week Balance exercise: Instructor-led exercises done in a group setting for strengthening, balance, flexibility
Visual Acuity - Mean Acuity Change	7.333 Letters read correctly Standard Deviation 8.501	-4.875 Letters read correctly Standard Deviation 10.58

SECONDARY outcome

Timeframe: 12 weeks

Contrast sensitivity: The contrast sensitivity of the subjects will be measured with the Pelli-Robson Chart or Contrast Sensitivity Chart following the instructions provided with the chart. The two sides of the Pelli-Robson Chart have different letter sequences but are otherwise identical. The chart should be illuminated as uniformly as possible, so that the luminance of the white areas is between 80 and 120 cd/ m2 with no glare. The patient should sit directly in front of the chart at a distance of 1 meter (use the same 1 meter string as for visual acuity testing to measure the eye-to-chart distance). Subjects should be prevented from seeing the chart until the contrast sensitivity testing actually begins. Subjects should wear their best distance correction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Aerobic Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Balance Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey H. Boatright, PhD

Atlanta VA

Phone: 404-321-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place