Exercise and RP (AVAMC and Emory)
Primary Purpose
Retinitis Pigmentosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spin exercise
Sponsored by
About this trial
This is an interventional prevention trial for Retinitis Pigmentosa focused on measuring Exercise, Quality of life, Progression of disease, Retinitis
Eligibility Criteria
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.
Sites / Locations
- Emory Clinic, Atlanta VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Moderate exercise
Mild exercise
Arm Description
Subjects in the moderate exercise group will participate in Spin exercise designed by Dr. Nocera.
Sessions will be focused on balance and stretching.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
Change in amount of autofluorescence before and after exercise
Change in amount of autofluorescence will be evaluated using autofluorescent imaging before and after exercise.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03381235
Brief Title
Exercise and RP (AVAMC and Emory)
Official Title
The Effects of Exercise on Progression of Disease and Quality of Life in Patients With Retinitis Pigmentosa - a Small Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
Exercise, Quality of life, Progression of disease, Retinitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moderate exercise
Arm Type
Experimental
Arm Description
Subjects in the moderate exercise group will participate in Spin exercise designed by Dr. Nocera.
Arm Title
Mild exercise
Arm Type
No Intervention
Arm Description
Sessions will be focused on balance and stretching.
Intervention Type
Other
Intervention Name(s)
Spin exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Brain-Derived Neurotrophic Factor (BDNF) level before and after exercise
Description
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.
Secondary Outcome Measure Information:
Title
Change in retina vasculature before and after exercise
Description
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.
Title
Change in retinal thickness before and after exercise
Description
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.
Title
Change in retinal pigment epithelium (RPE) pigmentation before and after exercise
Description
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.
Title
Change in degrees of vascular attenuation before and after exercise
Description
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.
Title
Change in amount of autofluorescence before and after exercise
Description
Change in amount of autofluorescence will be evaluated using autofluorescent imaging before and after exercise.
Time Frame
Baseline, 3 and 6 months follow up.
Title
Change in Goldmann Visual Field (GVF) scores
Description
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.
Title
Change in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) score
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiong Yan, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Clinic, Atlanta VA Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exercise and RP (AVAMC and Emory)
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