BFRT for Severe Lower Extremity Muscle Atrophy (BFRT)

Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy

Muscle weakness or atrophy is a common condition following acute and chronic musculoskeletal injuries. Strength training is an imperative component in clinical rehabilitation of musculoskeletal injuries. Heavy exercise loads (approximately 70% of one repetition maximum) is necessary to elicit muscle hypertrophy and strength gains. However, patients with severe muscle atrophy are frequently unable to tolerate these loads due to pain. Blood flow resistance training with low resistance loads may be used to safely develop muscle strength.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Severe Muscle Atrophy
• Intervention / Treatment: Other: Blood flow restriction training

Detailed Description

Blood flow restriction training (BFRT) is a safe type of low intensity resistance exercise that has demonstrated enhanced muscle growth, muscle strength, oxygen delivery and utilization (VO2Max). With BFRT, lighter loads can be used to build muscle while sparing the joints from heavy loading and without overly fatiguing the central nervous system.

The objectives of BFRT are 1) to increase the effectiveness of physical therapy, 2) safely increase muscle mass, reduce arterial stiffness, increase bone density, increase Vo2Max, improve carotid arterial compliance and enhance response of the autonomic nervous system, 3) improve muscle endurance in 1/3 the time, improve strength and hypertrophy after surgery, improve muscle recruitment and increase anabolic growth signaling.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Sportsmedicine and Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with > 20% deficit in isometric quadriceps and/or hamstrings strength
• Patients willing to complete at least 9 BFRT training sessions
• Patients willing to provide informed consent (or parental consent)

Exclusion Criteria:

• Pregnancy
• History of varicose veins
• History of blood clots or active blood clot
• Taking oral contraceptives
• History of heart attack
• Unstable cardiac disease
• Taking heart failure medication
• Uncontrolled hypertension (> 140/90)
• Uncontrolled tachycardia (> 100 bpm)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: BFRT with 4 exercises and low resistance loads; Blood flow resistance training will be performed with a standard blood pressure cuff that is placed and inflated by a clinician. The patient will perform 4 exercises with low resistance loads that will produce a muscle burn to enhance promotion of strength. Training will be supervised in the clinic. The cuff is deflated between exercises.

Other: Blood flow restriction training; BFRT is done with 4 exercises with low load resistance of 30% 1 repetition maximum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isometric quadriceps and hamstrings muscle strength	Isometric knee flexor and extensor strength will be measured with an isokinetic dynamometer before training and after each series of 9 training sessions	Strength will be measured for each patient before training begins and then after 9 training sessions have been completed, for the duration of the study, up to 100 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient rating	Patients will rate the intensity of muscle burn produced during training and overall satisfaction with the final result	The intensity of muscle burn will be determined during each training session. The overall satisfaction will be determined after the last training session for each patient, for the duration of the study, up to 100 weeks.

Collaborators and Investigators

• Sponsor: Cincinnati Sportsmedicine Research and Education Foundation
• Investigators: Principal Investigator: Frank R Noyes, MD, Cincinnati Sportsmedicine Research and Education Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2020
• Primary Completion (ACTUAL): February 15, 2022
• Study Completion (ACTUAL): February 15, 2022

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (ACTUAL): April 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscle Weakness; Muscular Atrophy; Atrophy
• Other Study ID Numbers: BFRT17-37

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