Blood Flow Restriction Training for People With Disabilities

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.

Study Overview

• Status: Recruiting
• Conditions: Weakness, Muscle
• Intervention / Treatment: Other: Blood flow restriction training; Other: No blood flow restriction training

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghann Sytsma; Phone Number: 414-955-1922; Email: mesytsma@mcw.edu
• Study Contact Backup: Name: Beth Weinman, DO; Phone Number: 414-955-1922; Email: bweinman@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Beth Weinman, DO; Phone Number: 414-805-7100; Email: bweinman@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• History of an upper limb deep vein thrombosis
• History of autonomic dysreflexia
• Upper extremity fracture within the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low load resistance training with blood flow restriction; Low load resistance training routine at 30-50% of a person's 1-repetition maximum with arterial occlusion pressure at 80%	Other: Blood flow restriction training; Participants randomized to blood flow restriction training will complete low load resistance training exercises while the limb is occluded at 80% arterial occlusion pressure.
Active Comparator: Low load resistance training; Low load resistance training routine at 30-50% of a person's 1-repetition maximum	Other: No blood flow restriction training; Participants randomized to no blood flow restriction training will complete low load resistance without occlusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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.	6 weeks
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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.	6 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Disability; Blood flow restriction; Low load blood flow restriction training
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Weakness; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: PRO00051215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No