Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06441422 |
| Other study ID # |
PRO00051215 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Medical College of Wisconsin |
| Contact |
Beth Weinman, DO |
| Phone |
414-955-1922 |
| Email |
bweinman[@]mcw.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
A large portion of the American population live with disabilities. People with disabilities
can find it difficult to perform standard exercise routines. Regular exercise is necessary to
be healthy, especially as people age. Lack of exercise can lead to secondary health concerns,
like loss of muscle mass, diabetes, heart attack or stroke, to name a few. For exercise to be
most beneficial, a certain degree of intensity must be achieved. Low load blood flow
restriction training may be able to mimic the intensity of beneficial exercise without
actually exercising hard. It may be a good option for people with disabilities who find it
difficult to exercise.
Description:
A significant portion of the American population currently lives with a disability. There are
about 300,000 Americans living with a spinal cord injury (SCI) with approximately 18,000 new
cases each year. Cerebrovascular accidents (CVA), or strokes, occur at 795,000 new cases per
year in the USA with strokes being the third-leading cause of death and disability combined
in the world3. There are about 750,000 US adults living with multiple sclerosis (MS), 30,000
US adults with ALS, about 1400 Americans are born each year with spina bifida, about 11,000
Americans are born each year with cerebral palsy, and there were 1.6 million American
amputees as of 2005, with that number expected to double by 2050. These disabilities tend to
reduce the activity levels of these individuals, which puts them at an increased risk of
developing comorbidities such as obesity, insulin resistance, dyslipidemia, and more. These
comorbidities are often already present in those who have had a CVA, and those who are older
experience an even greater burden than those who are younger. Thus, exercise regimens are
crucial to maintaining their health.
Aging is associated with an increase in susceptibility to injury and a decrease in functional
ability related to a decrease in muscle size and strength. This age-related decrease is also
known as primary sarcopenia. Resistance exercise, such as weightlifting, has been shown to
improve muscle size and strength and functional ability in elderly individuals, and
resistance exercise is widely regarded as the best method to slow the progression of primary
sarcopenia. Resistance exercise and physical activity has also been shown to reduce the odds
of developing sarcopenia later in life, suggesting an impetus for beginning an exercise
regimen while young, though any age will benefit.
Blood flow restriction (BFR) training is a method of exercise that involves restricting the
participant's blood flow to the target muscle group during exercise. Historically, training
to increase muscle thickness and strength occurs at 70% of a person's 1 repetition maximum
(1RM), which is the maximum weight someone can lift in one repetition (rep) of a given
exercise. For example, if someone's 1RM for barbell biceps curl is 100lbs, he could train at
70lbs for 3 sets of 8-12 to increase his biceps curl 1RM and the size of his biceps. This
training is hereto referred as high intensity resistance training (HLRT). Training at 30-50%
1RM with BFR, hereto referred as low load blood flow restriction training (LLBFR), increases
muscle thickness similar to training at 50-80% 1RM without BFR. This also results in an
increase in strength due to the increase in overall muscle mass. LLBFR training regimens also
display greater increases in muscle size and strength when compared to identical exercise
regimens but without BFR. So, training barbell biceps curl at 30-50lbs with blood flow
restriction will increase biceps size similarly to our HLRT example. It will increase biceps
strength too, but likely not to the same degree as our HLRT example. However, the increase in
biceps strength and size in this LLBFR example will be greater than if this person trained at
30-50lbs but without BFR. Thus, LLBFR can induce similar benefits to traditional HLRT but
with a much lighter load.
Due to the efficacy and efficiency of LLBFR in increasing muscle size and strength, it has
been proposed as an alternate exercise regimen for those unable to tolerate, or are
contraindicated for, traditional HLRT, such as the elderly or individuals with disabilities.
This study proposes to examine if LLBFR is beneficial when compared to traditional low load
resistance training.
