Blood Flow Restriction Training for People With Disabilities

NCT06441422 | Recruiting

• 1 other identifier: PRO00051215
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Weakness, Muscle

Keywords

Disability; Blood flow restriction; Low load blood flow restriction training

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  6 weeks

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

  6 weeks

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

  6 weeks

Study Arms (2)

Low load resistance training with blood flow restriction

EXPERIMENTAL

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

Low load resistance training

ACTIVE COMPARATOR

Low load resistance training routine at 30-50% of a person's 1-repetition maximum

Other: No blood flow restriction training

Interventions

Blood flow restriction training OTHER

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

Low load resistance training with blood flow restriction

No blood flow restriction training OTHER

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

Low load resistance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Muscle Weakness

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Beth Weinman, DO

CONTACT

414-955-1922; bweinman@mcw.edu

Meghann Sytsma

CONTACT

414-955-1922; mesytsma@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 4, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)