Exercise and RP (AVAMC and Emory)

The Effects of Exercise on Progression of Disease and Quality of Life in Patients With Retinitis Pigmentosa - a Small Pilot Study

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).

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Other: Spin exercise

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic, Atlanta VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Jiong Yan, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 23, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Quality of life; Retinitis; Progression of disease
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: IRB00093690

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No