Retinitis PigmentosaNCT03381235
Exercise and RP (AVAMC and Emory)
A study testing Spin exercise in people with Retinitis Pigmentosa, run by Emory University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- Spin exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Visual field no less than 10 degrees;
- VA no worse than 20/200 in the better seeing eye.
Who cannot join
- Not able to tolerate exercise due to an underlying medical condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Clinic, Atlanta VA Medical Center
Atlanta, Georgia, 30322
About this study
Official title: 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).
Read the 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).
- Conditions
- Retinitis Pigmentosa
- Being tested
- Spin exercise
- Keywords
- Exercise, Quality of life, Progression of disease, Retinitis
- Medical subject headings
- Retinitis Pigmentosa, Motor Activity, Retinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate exercise | Experimental | Subjects in the moderate exercise group will participate in Spin exercise designed by Dr. Nocera. Receives: Other: Spin exercise |
| Mild exercise | No intervention | Sessions will be focused on balance and stretching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3 and 6 months follow up.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 and 6 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start23 Feb 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong Yan, Emory University
- Investigators
- Jiong Yan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381235
- Sponsor's protocol ID
- IRB00093690
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise on Progression of Disease and Quality of Life in Patients With Retinitis Pigmentosa - a Small Pilot Study
- ClinicalTrials.gov ID
- NCT03381235
- Acronym / sponsor ID
- IRB00093690
- Conditions
- Retinitis Pigmentosa
- Keywords
- Exercise, Quality of life, Progression of disease, Retinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate exercise | Experimental | Other: Spin exerciseSubjects in the moderate exercise group will participate in Spin exercise designed by Dr. Nocera. |
| Mild exercise | No intervention | –Sessions will be focused on balance and stretching. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Visual field no less than 10 degrees;
- VA no worse than 20/200 in the better seeing eye.
Key exclusion criteria (1 listed)
- Not able to tolerate exercise due to an underlying medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spin exerciseEach 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. | Other | Moderate exercise |
Primary outcome
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
7 secondary outcomes
Change in retina vasculature before and after exercise
Time frame: Baseline, 3 and 6 months follow up.
Change in retinal thickness before and after exercise
Time frame: Baseline, 3 and 6 months follow up.
Change in retinal pigment epithelium (RPE) pigmentation before and after exercise
Time frame: Baseline, 3 and 6 months follow up.
Change in degrees of vascular attenuation before and after exercise
Time frame: Baseline, 3 and 6 months follow up.
Change in amount of autofluorescence before and after exercise
Time frame: Baseline, 3 and 6 months follow up.
Change in Goldmann Visual Field (GVF) scores
Time frame: Baseline, 3 and 6 months follow up.
Change in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) score
Time frame: Baseline, 3 and 6 months follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiong Yan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spin exercise in people with Retinitis Pigmentosa, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain-Derived Neurotrophic Factor (BDNF) level before and after exercise (time frame: Baseline, 3 and 6 months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.