CLINICAL TRIAL

Blood Flow Restriction Exercise for Multiple Sclerosis

Recruiting · 18+ · All Sexes · Aurora, CO

This study is evaluating whether a new type of physical therapy may help improve walking ability for individuals with multiple sclerosis.

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About the trial for Multiple Sclerosis

Eligible Conditions
Sclerosis · Multiple Sclerosis

Treatment Groups

This trial involves 2 different treatments. Blood Flow Restriction Exercise 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 Exercise
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adults ages 18-70
Neurologist-confirmed diagnosis of multiple sclerosis
Expanded Disability Status Scale (EDSS) 6.0 to 7.0
EDSS 6.0: unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting
EDSS 6.5: Bilateral assistance (cane or crutch) required to walk at least 20 meters with or without resting
EDSS 7.0: unable to walk 5 meters even with aid, essentially restricted to wheelchair; wheels self and transfers alone; up and about in wheelchair some 12 hours a day
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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: Measured at Baseline (Week 0) and Post Test (Week 9)
Screening: ~3 weeks
Treatment: Varies
Reporting: Measured at Baseline (Week 0) and Post Test (Week 9)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Measured at Baseline (Week 0) and Post Test (Week 9).
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 Exercise will improve 3 primary outcomes and 8 secondary outcomes in patients with Multiple Sclerosis. Measurement will happen over the course of Measured at Baseline (Week 0) and Post Test (Week 9).

Change in MS Impact Scale-29
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Self-report questionnaire measuring the impact of MS on daily activity with scores ranging from 29 (MS has no impact on my daily life) to 145 (MS extremely impacts my daily life)
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Change in 12-Item MS Walking Scale
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Self-report questionnaire measuring walking ability with scores ranging from 12 points (no difficulty walking, to 60 points (extremely limited or no walking)
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Change in Modified Fatigue Impact Scale
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Self-report questionnaire measuring fatigue caused by MS with scores ranging from 0 (no impact of fatigue in the past 4 weeks) to 84 (maximum impact of fatigue in the past 4 weeks)
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Change in 30-second sit-to-stand completions
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Change in timed 25-foot walk
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Functional mobility test measuring the time it takes a participant to walk 25 feet
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Change in Berg Balance Scale
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
Functional mobility test measuring the participant's ability to balance in different postures. Scores range from 0 to 56 points, with 0-20 points indicating wheelchair bound, 21-40 indicating walking with assistance, and 41-56 indicating walking independently.
MEASURED AT BASELINE (WEEK 0) AND POST TEST (WEEK 9)
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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 causes multiple sclerosis?

Although the cause of MS remains unknown, some studies suggest viral or environmental exposures. The genetic component of MS appears to be important, and risk factors associated with maternal age in the past are linked to risk of MS in children. The lack of agreement among researchers on the risk and pathogenesis of MS, the differences in their methodology, and the scarcity of evidence to support any of the various hypotheses (e.g. environmental or viral aetiology of MS) make it difficult to pinpoint the exact pathogenesis of MS.

Anonymous Patient Answer

What are the signs of multiple sclerosis?

Symptoms of multiple sclerosis include decreased or absent sensation from the feet and hands, weakness, fatigue and mental status changes. There is also a high rate of cognitive impairment with multiple sclerosis.

Anonymous Patient Answer

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

There is no clear reason why there is not a year in the year with an average of 1000 people getting MS in the US. The reason why there is so much variation and the number so low might be because of the varying levels of genetic susceptibility to MS and perhaps the different lifestyles of people living in different areas of the United States. The number of people getting MS is expected to have a much larger year in the year 2100 than today.

Anonymous Patient Answer

What is multiple sclerosis?

A person can develop multiple sclerosis at any age and any time. Its signs and symptoms can vary, but all people affected have some form of brain damage. If someone is diagnosed with multiple sclerosis in early adulthood, they are at a higher risk of developing the disease in later life. There are at least two races that appear to be more likely to deal with symptoms. People with darker skin who are of European origin are at a higher risk for developing the disease as they are more prone to sunlight exposure.

Anonymous Patient Answer

What are common treatments for multiple sclerosis?

Various drug-based treatments and procedures are used by clinicians in the management of MS patients. Most current therapies are aimed at improving the symptoms of the disease. Nevertheless, recent developments in drug research are aimed at minimizing the side effects of some previously used treatments.

Anonymous Patient Answer

Can multiple sclerosis be cured?

There are many ways to view the disease-modifying effect, which has been called 'no evidence of natural cure'. Further research is required before any definite conclusions can be reached.

Anonymous Patient Answer

How serious can multiple sclerosis be?

Very serious indeed. MS can be life threatening in 20-40% cases. Very little about the course of MS is understood and how it affects the patient is not yet known. There is a lot of fear expressed toward those with MS and how serious their disease is, even though they probably will have good health care. Most hope MS will not be the reason for a terminal illness.

Anonymous Patient Answer

Have there been other clinical trials involving blood flow restriction exercise?

There are currently only one other trials with similar design and results, as well as two similar trials with only a small sample size. Both indicated an improvement which was not seen in this study. Results from a recent clinical trial make us believe more studies with larger sample are needed at this time.

Anonymous Patient Answer

Does multiple sclerosis run in families?

Multiple sclerosis was most prevalent among siblings, but the prevalence did not change with increasing family degree, contrary to what one might expect if genetic factors made MS a familial disease.

Anonymous Patient Answer

Who should consider clinical trials for multiple sclerosis?

A multidisciplinary, multidisciplinary treatment approach, including rheumatology, physiatry, occupational therapy, physical therapy, neuropsychology, and rehabilitation, and that includes MS rehabilitation, should be considered when the patient has disabling symptoms and/or is an absolute or relative MS-risk candidate for participation in an MS clinical trial. To increase the likelihood that a patient is an absolute/relative risk for MS, patients with certain characteristics and genotypes must have a positive clinical trial response to a placebo or MS drugs.

Anonymous Patient Answer

Does blood flow restriction exercise improve quality of life for those with multiple sclerosis?

Exercise with BFR has the potential to deliver measurable improvements to quality of life for those with MS and provide an additional mode of exercise practice for individuals with MS in the clinic.

Anonymous Patient Answer

How does blood flow restriction exercise work?

The protocol that was developed for this study was well received from participants and can be recommended to those with MS as a safe form of exercise to increase strength. Recent findings are promising and need to be substantiated further before larger studies can be recommended.

Anonymous Patient Answer
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