CLINICAL TRIAL

Blood Flow Restriction for Sclerosis

Recruiting · 18 - 65 · Female · Orlando, FL

Low-Load Blood Flow Restriction on Patients With Multiple Sclerosis

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About the trial for Sclerosis

Eligible Conditions
Sclerosis · Training Study · Multiple Sclerosis · Blood Flow Restriction

Treatment Groups

This trial involves 2 different treatments. Blood Flow Restriction is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Blood Flow Restriction
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Standard of Care
OTHER

Eligibility

This trial is for female patients between 18 and 65 years old. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person is saying that they are willing to come in for all 29 testing visits. show original
at the age of 21 I was diagnosed with MS when I was 21. show original
I can walk 10 meters without assistance. show original
The expanded disability status score (EDSS) ranges from 0 to 6.5, with a higher score indicating a more severe disability. show original
Females between the ages of 18 to 55
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 3, Week 4 and 8, Day 29
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 3, Week 4 and 8, Day 29
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 3, Week 4 and 8, Day 29.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Blood Flow Restriction will improve 5 primary outcomes and 1 secondary outcome in patients with Sclerosis. Measurement will happen over the course of Day 2, Week 4 and 8, Day 28.

Change in Functional Outcomes- 30CST
DAY 2, WEEK 4 AND 8, DAY 28
determined via changes in 30 second sit-to-stand, measured by how many times someone can stand from a seated position in 30 seconds
DAY 2, WEEK 4 AND 8, DAY 28
Change in Functional Outcomes- 10meter
DAY 2, WEEK 4 AND 8, DAY 28
determined via changes in 10 meter walk test, measured by how fast (in minutes and seconds) someone can walk 10 meters
DAY 2, WEEK 4 AND 8, DAY 28
Change in Functional Outcomes- CST
DAY 2, WEEK 4 AND 8, DAY 28
determined via changes in sit-to-stand test, measured by how quickly someone can stand from a seated position
DAY 2, WEEK 4 AND 8, DAY 28
Change in Functional Outcomes- MFIS
DAY 2, WEEK 4 AND 8, DAY 28
determined via changes in Modified Fatigue Impact Scale Questionnaire, sum score of answers on the questionnaire
DAY 2, WEEK 4 AND 8, DAY 28
Change in Functional Outcomes- 6min walk
DAY 2, WEEK 4 AND 8, DAY 28
determined via changes in 6 minute walk test, measured by how far (in feet) someone can walk in 6 minutes
DAY 2, WEEK 4 AND 8, DAY 28
Changes in Strength
DAY 3, WEEK 4 AND 8, DAY 29
determined via maximal voluntary contractions on the Biodex
DAY 3, WEEK 4 AND 8, DAY 29

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is sclerosis?

A few key characteristics of sclerosis should be considered. In the beginning, symptoms are similar to those found in any chronic condition where blood clot formation is abnormal. In the late stages of the disease, the formation of blood clots is not a main problem, though clot formation can persist. Patients will notice the first noticeable symptom in the beginning of their fifties. Although symptoms can be controlled for some time, recovery from the debilitating symptoms of a sclerosis related illness is a rare phenomenon. However, once symptoms have been controlled, patients can often live a normal life.

Anonymous Patient Answer

What are common treatments for sclerosis?

Arterial stiffness is common both within and among different ethnic groups and can be reduced and/or controlled through pharmacology, exercise and lifestyle modifications. These can benefit the majority of patients with arterial sclerosis.

Anonymous Patient Answer

How many people get sclerosis a year in the United States?

There is little agreement on rates of scleroderma among American rheumatologists. There is great variability in the numbers of Medicare and private claims from different clinical practices.

Anonymous Patient Answer

What causes sclerosis?

There is no single cause of scleroderma: there are triggers causing scleroderma to develop, and autoimmune, genetic and hormonal factors that affect scleroderma’s development. Scleroderma can also develop after long periods of not having symptoms, with various other conditions raising the risk for scleroderma, often in combination.\n

Anonymous Patient Answer

What are the signs of sclerosis?

sclerosis is an age-related disorder that leads to loss of joint function, joint space narrowing, decreased range of movement, osteoarthritis, and osteoporosis. Sclerosis is more common in females and presents most commonly with knee osteoarthritis with increased pain. This disease does not always lead to deformity and amputations. Sclerosis patients may be symptomatic, but will have no deformity and will not require surgery.

Anonymous Patient Answer

Have there been any new discoveries for treating sclerosis?

The current therapies to treat sclerosis including steroids in steroid-responsive SSc and intravenous immune globulin in SSc have been proven satisfactory and have not been replaced by any other treatments.

Anonymous Patient Answer

What is the primary cause of sclerosis?

There are multiple diseases that cause sclerosis: they are not the primary cause of this disease. The primary cause is unknown but likely involves genetics, the environment, inflammation and viral infections.

Anonymous Patient Answer

Have there been other clinical trials involving blood flow restriction?

There was a significant reduction in blood flow to the affected area after 10-minutes of treatment. This decrease was related to a significant decrease in heart rate and oxygen saturation as well as an increase in blood flow velocity in the area. Patients also reported that they found the exercise painful. Although blood flow restriction is a very new treatment for heart disease, further prospective research and trials are needed to establish its use as a cardiovascular medicine.

Anonymous Patient Answer

How does blood flow restriction work?

The application of BF is not a useful tool for peripheral artery remodelling. Although it has been demonstrated that BF is able to reduce vascular remodelling, blood flow redistribution could be an alternative mechanism. Although this has not been studied directly, it could explain the inconsistent results that have been obtained with BF application to the extremities.

Anonymous Patient Answer

What is the latest research for sclerosis?

Scler sclerosis is the most common presentation of chronic liver disease. Although the liver is affected in over 75% of patients with scleroderma and only 15% of patients with [primary biliary cirrhosis](https://www.withpower.com/clinical-trials/primary-biliary-cirrhosis) it seems that only a minority of patients will develop liver cirrhosis. There is some evidence that statin use may reduce the risk of developing severe liver problems. Liver transplantation is the standard treatment for those with end stage liver disease. The new class of immunosuppressant drugs has expanded the potential options for patients with scleroderma and have significantly improved patients' functional status.

Anonymous Patient Answer

What does blood flow restriction usually treat?

These data are consistent with the hypothesis that decreased tissue oxygenation and metabolic fluxes from blood to tissues plays a role in the treatment of various musculoskeletal conditions. These observations are in agreement with previous animal and human data and warrant further evaluation of blood flow restriction as the new paradigm in the management of musculoskeletal pain.

Anonymous Patient Answer
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