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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03381235
Other study ID # IRB00093690
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 23, 2018
Est. completion date November 28, 2018

Study information

Verified date December 2018
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to look in humans at the relationship between moderate or little exercise and their potential effects on the retina in patients with Retinitis Pigmentosa (RP).


Description:

Human studies have shown that regular exercise may have positive effects on common degenerative diseases such as Alzheimer's disease. Exercise has also shown to improve conditions the eye such as macular degenerations, glaucoma, and cataracts. Mice with retinal degeneration which were exposed to exercise showed that it helped to slow the rate of degeneration. The purpose of this study is to look in humans at the relationship between moderate or little exercise and their potential effects on the retina in patients with Retinitis Pigmentosa (RP).


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date November 28, 2018
Est. primary completion date November 28, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Visual field no less than 10 degrees;

- VA no worse than 20/200 in the better seeing eye.

Exclusion Criteria:

- Not able to tolerate exercise due to an underlying medical condition.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Spin exercise
Each exercise class will consist of 20 minutes of progressive, interval based Spin exercise 2 times a week for 6 months on stationary exercise cycles and will be led by a qualified instructor. The Duration of each session is lengthened based on the progression of the participant and the recommendation of the instructor by 1-2 minutes as needed to a maximum time of 60 minutes per session. Exercise intensity will begin at low levels (50% of maximal heart rate reserve (HRR) and increase by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.

Locations

Country Name City State
United States Emory Clinic, Atlanta VA Medical Center Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Brain-Derived Neurotrophic Factor (BDNF) level before and after exercise Sertum levels of BDNF in patients before and exercise program will be measured by testing blood Baseline, 3 and 6 months follow up.
Secondary Change in retina vasculature before and after exercise Optical Coherence Tomography Angiography (OCTA) will serve as a tool to study retina vasculature, including choroidal, superficial and deep retinal vascular filling status and permeability, before and after exercise. Baseline, 3 and 6 months follow up.
Secondary Change in retinal thickness before and after exercise Change in retinal thickness will be evaluated using spectral-domain optical coherence tomography (SD-OCT) before and after exercise. Baseline, 3 and 6 months follow up.
Secondary Change in retinal pigment epithelium (RPE) pigmentation before and after exercise Change in retinal RPE pigmentation will be evaluated using Optos wide-field fundus photography before and after exercise. Baseline, 3 and 6 months follow up.
Secondary Change in degrees of vascular attenuation before and after exercise Change in degrees of vascular attenuation will be evaluated using Optos wide-field fundus photography before and after exercise. Baseline, 3 and 6 months follow up.
Secondary Change in amount of autofluorescence before and after exercise Change in amount of autofluorescence will be evaluated using autofluorescent imaging before and after exercise. Baseline, 3 and 6 months follow up.
Secondary Change in Goldmann Visual Field (GVF) scores The final result of a GVF is a diagram "island of vision." The visual field is an island with a central peak and the altitude correlates with the visual sensitivity in a given location. Baseline, 3 and 6 months follow up.
Secondary Change in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) score NEI VFQ-25 measures the range of vision-related functioning experienced by persons. The 12 subscales in the NEI VFQ-25 are general vision, near vision, distance vision, driving, peripheral vision, color vision, ocular pain, general health, and vision-specific role difficulties, dependency, social function, and mental health. The subscale scores are calculated by summing the relevant items and transforming the raw scores into a 0 to 100 scale where higher scores indicate better functioning or well-being. Baseline, 3 and 6 months follow up.
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