NCT03381235

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 23, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

December 13, 2017

Last Update Submit

December 23, 2018

Conditions

Retinitis Pigmentosa

Keywords

ExerciseQuality of lifeProgression of diseaseRetinitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in retina vasculature before and after exercise

    Baseline, 3 and 6 months follow up.

  • Change in retinal thickness before and after exercise

    Baseline, 3 and 6 months follow up.

  • Change in retinal pigment epithelium (RPE) pigmentation before and after exercise

    Baseline, 3 and 6 months follow up.

  • Change in degrees of vascular attenuation before and after exercise

    Baseline, 3 and 6 months follow up.

  • Change in amount of autofluorescence before and after exercise

    Baseline, 3 and 6 months follow up.

  • +2 more secondary outcomes

Study Arms (2)

Moderate exercise

EXPERIMENTAL

Subjects in the moderate exercise group will participate in Spin exercise designed by Dr. Nocera.

Other: Spin exercise

Mild exercise

NO INTERVENTION

Sessions will be focused on balance and stretching.

Interventions

Spin exerciseOTHER

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.

Moderate exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Visual field no less than 10 degrees;
  • VA no worse than 20/200 in the better seeing eye.

You may not qualify if:

  • Not able to tolerate exercise due to an underlying medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Clinic, Atlanta VA Medical Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Retinitis PigmentosaMotor ActivityRetinitis

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • Jiong Yan, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 21, 2017

Study Start

February 23, 2018

Primary Completion

November 28, 2018

Study Completion

November 28, 2018

Last Updated

December 26, 2018

Record last verified: 2018-12

Locations

US(1)