Viewing Study NCT06441422



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06441422
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-04
First Post: 2024-05-20

Brief Title: Blood Flow Restriction Training for People With Disabilities
Sponsor: Medical College of Wisconsin
Organization: Medical College of Wisconsin

Study Overview

Official Title: Effectiveness of Low Load Resistance Training With Blood Flow Restriction in Individuals With Disabilities
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: A significant portion of the American population currently lives with a disability There are about 300000 Americans living with a spinal cord injury SCI with approximately 18000 new cases each year Cerebrovascular accidents CVA or strokes occur at 795000 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 750000 US adults living with multiple sclerosis MS 30000 US adults with ALS about 1400 Americans are born each year with spina bifida about 11000 Americans are born each year with cerebral palsy and there were 16 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 participants blood flow to the target muscle group during exercise Historically training to increase muscle thickness and strength occurs at 70 of a persons 1 repetition maximum 1RM which is the maximum weight someone can lift in one repetition rep of a given exercise For example if someones 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None