Exercise and RP (AVAMC and Emory)
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|ClinicalTrials.gov Identifier: NCT03381235|
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Other: Spin exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Exercise on Progression of Disease and Quality of Life in Patients With Retinitis Pigmentosa - a Small Pilot Study|
|Actual Study Start Date :||February 23, 2018|
|Actual Primary Completion Date :||November 28, 2018|
|Actual Study Completion Date :||November 28, 2018|
Experimental: Moderate exercise
Subjects in the moderate exercise group will participate in Spin exercise designed by Dr. Nocera.
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.
No Intervention: Mild exercise
Sessions will be focused on balance and stretching.
- Change in Brain-Derived Neurotrophic Factor (BDNF) level before and after exercise [ Time Frame: Baseline, 3 and 6 months follow up. ]Sertum levels of BDNF in patients before and exercise program will be measured by testing blood
- Change in retina vasculature before and after exercise [ Time Frame: Baseline, 3 and 6 months follow up. ]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.
- Change in retinal thickness before and after exercise [ Time Frame: Baseline, 3 and 6 months follow up. ]Change in retinal thickness will be evaluated using spectral-domain optical coherence tomography (SD-OCT) before and after exercise.
- Change in retinal pigment epithelium (RPE) pigmentation before and after exercise [ Time Frame: Baseline, 3 and 6 months follow up. ]Change in retinal RPE pigmentation will be evaluated using Optos wide-field fundus photography before and after exercise.
- Change in degrees of vascular attenuation before and after exercise [ Time Frame: Baseline, 3 and 6 months follow up. ]Change in degrees of vascular attenuation will be evaluated using Optos wide-field fundus photography before and after exercise.
- Change in amount of autofluorescence before and after exercise [ Time Frame: Baseline, 3 and 6 months follow up. ]Change in amount of autofluorescence will be evaluated using autofluorescent imaging before and after exercise.
- Change in Goldmann Visual Field (GVF) scores [ Time Frame: Baseline, 3 and 6 months follow up. ]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.
- Change in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) score [ Time Frame: Baseline, 3 and 6 months follow up. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381235
|United States, Georgia|
|Emory Clinic, Atlanta VA Medical Center|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Jiong Yan, MD||Emory University|