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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
Sponsor:
Information provided by (Responsible Party):
Jiong Yan, Emory University

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).

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Other: Spin exercise Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, Georgia
Emory Clinic, Atlanta VA Medical Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Jiong Yan, MD Emory University

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Responsible Party: Jiong Yan, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03381235     History of Changes
Other Study ID Numbers: IRB00093690
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiong Yan, Emory University:
Exercise
Quality of life
Progression of disease
Retinitis

Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn