An interventional study of Spin exercise in Retinitis Pigmentosa, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-12-26.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
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).
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).
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's enrollment of 4 is below the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Exclusion Criteria:
Subjects in the moderate exercise group will participate in Spin exercise designed by Dr. Nocera.
Other: Spin exercise
Sessions will be focused on balance and stretching.
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.
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
Time frame: Baseline, 3 and 6 months follow up.
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.
Time frame: Baseline, 3 and 6 months follow up.
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.
Time frame: Baseline, 3 and 6 months follow up.
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.
Time frame: Baseline, 3 and 6 months follow up.
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.
Time frame: Baseline, 3 and 6 months follow up.
Change in amount of autofluorescence before and after exercise
Change in amount of autofluorescence will be evaluated using autofluorescent imaging before and after exercise.
Time frame: Baseline, 3 and 6 months follow up.
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.
Time frame: Baseline, 3 and 6 months follow up.
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.
Time frame: Baseline, 3 and 6 months follow up.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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