Exercise and RP (AVAMC and Emory)

Retinitis Pigmentosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381235
• Other study ID #: IRB00093690
• Status: Completed
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: December 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

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.

Locations

Country	Name	City	State
United States	Emory Clinic, Atlanta VA Medical Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.