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Weakness, MuscleNCT06441422

Blood Flow Restriction Training for People With Disabilities

A study testing Blood flow restriction training and No blood flow restriction training in people with Weakness, Muscle, run by Medical College of Wisconsin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Weakness, Muscle
What is being tested?
Blood flow restriction training and No blood flow restriction training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
12 Dec 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female
  • Age > or = 18
  • English speaking
  • Able to understand and perform upper extremity exercises

Who cannot join

  • Pregnant
  • Body mass index >40 kg·m-2
  • Uncontrolled hypertension (>150/90 mmHg)
  • Presence of neuromuscular junction and other muscle diseases
  • Myocardial infarction in the past 6 months
  • Unstable cardiovascular disease
Show all 9Show fewer
  • History of an upper limb deep vein thrombosis
  • History of autonomic dysreflexia
  • Upper extremity fracture within the last 6 months

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Beth Weinman, DO contact

414-955-1922

bweinman@mcw.edu

Meghann Sytsma contact

414-955-1922

mesytsma@mcw.edu

United States1 site, 1 recruiting
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Beth Weinman, DO, 414-805-7100, bweinman@mcw.edu

    Recruiting

Other trials in United States

About this study

Official title: Effectiveness of Low Load Resistance Training With Blood Flow Restriction in Individuals With Disabilities

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.

Read the detailed 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.

Being tested
Blood flow restriction training, No blood flow restriction training
Keywords
Disability, Blood flow restriction, Low load blood flow restriction training
Medical subject headings
Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood flow restriction trainingOther

    Participants randomized to blood flow restriction training will complete low load resistance training exercises while the limb is occluded at 80% arterial occlusion pressure.

  • No blood flow restriction trainingOther

    Participants randomized to no blood flow restriction training will complete low load resistance without occlusion.

Study groups in NCT06441422
Study groupRoleWhat they receive
Low load resistance training with blood flow restrictionExperimentalLow load resistance training routine at 30-50% of a person's 1-repetition maximum with arterial occlusion pressure at 80%
Receives: Other: Blood flow restriction training
Low load resistance trainingActive comparatorLow load resistance training routine at 30-50% of a person's 1-repetition maximum
Receives: Other: No blood flow restriction training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in strength between low load blood flow restriction resistance training and low load resistance training

    This outcome will measure the efficacy of low load blood flow restriction training (LLBFR) on muscle strength. The difference in muscle strength as measured by change in 1-repetition maximum weight in pounds will be compared in individuals training with LLBFR on their arm extensors and individuals training with low load resistance training (LLRT) on their arm extensors compared to their baseline.

    Measured: 6 weeks

  2. Difference in arm circumference between low load blood flow restriction resistance training and low load resistance training

    This outcome will measure the efficacy of low load blood flow restriction training (LLBFR) on arm circumference. The difference in arm circumference as measured by tape measure will be the change in centimeters in individuals training with LLBFR on their arm extensors compared to individuals training with low load resistance training (LLRT) on their arm extensors when compared to their respective baseline.

    Measured: 6 weeks

  3. Difference in muscle thickness change between low load blood flow restriction resistance training and low load resistance training

    This outcome will measure the efficacy of low load blood flow restriction training (LLBFR) on muscle thickness. The difference in muscle thickness as measured by ultrasound will be the change in centimeters in individuals training with LLBFR on their arm extensors compared to individuals training with low load resistance training (LLRT) on their arm extensors when compared to their respective baseline.

    Measured: 6 weeks

Secondary outcomes (3)
  1. The interaction effect between disability status (disable versus able-bodied) and training group (LLBFR and LLRT) on the change in strength.

    Response to training in individuals with disabilities. The results of LLBFR on muscle strength as measured by change in pounds of 1-repetition maximum to the arm extensors will be compared between those with disabilities and those without.

    Measured: 6 weeks

  2. The interaction effect between disability status (disable versus able-bodied) and training group (LLBFR and LLRT) on the change in arm circumference.

    Response to training in individuals with disabilities. The results of LLBFR on arm circumference as measured by change in centimeters as measured by tape measure to the arm extensors will be compared between those with disabilities and those without.

    Measured: 6 weeks

  3. The interaction effect between disability status (disable versus able-bodied) and training group (LLBFR and LLRT) on the change in muscle thickness.

    Response to training in individuals with disabilities. The results of LLBFR on muscle thickness as measured by ultrasound in change in centimeters to the muscle thickness will be compared between those with disabilities and those without.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start12 Dec 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06441422
Sponsor's protocol ID
PRO00051215
Status last verified
Apr 2026
First submitted
20 May 2024
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood flow restriction training and No blood flow restriction training in people with Weakness, Muscle, run by Medical College of Wisconsin 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beth Weinman, DO (414-955-1922, bweinman@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in strength between low load blood flow restriction resistance training and low load resistance training (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 1 May 2026.

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