BFRT for Severe Lower Extremity Muscle Atrophy

NCT ID: NCT04357184

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-14
• Study Completion Date: 2022-02-15

Brief Summary

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.

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.

Conditions

Severe Muscle Atrophy; Muscle Weakness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blood flow restriction training

Intervention Type: OTHER

BFRT is done with 4 exercises with low load resistance of 30% 1 repetition maximum

Interventions

Blood flow restriction training

BFRT is done with 4 exercises with low load resistance of 30% 1 repetition maximum

Intervention Type: OTHER

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cincinnati Sportsmedicine Research and Education Foundation

OTHER

Sponsor Role: lead

Responsible Party

Sue Barber-Westin

Director Clinical Studies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank R Noyes, MD

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Sportsmedicine Research and Education Foundation

Locations

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

BFRT17-37

Identifier Type: -

Identifier Source: org_study_id