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Completed

NCT Number: NCT03381235

Exercise and RP (AVAMC and Emory)

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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Key information

Conditions

Retinitis Pigmentosa Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Motor Activity Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Clinic, Atlanta VA Medical Center

Atlanta, Georgia, 30322, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spin exercise

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2017
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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