BFRT for Severe Lower Extremity Muscle Atrophy

Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy

Sponsors

Lead Sponsor: Cincinnati Sportsmedicine Research and Education Foundation

Source Cincinnati Sportsmedicine Research and Education Foundation
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.

Overall Status Completed
Start Date 2020-04-14
Completion Date 2022-02-15
Primary Completion Date 2022-02-15
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Isometric quadriceps and hamstrings muscle strength 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
Measure Time Frame
Patient rating 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.
Enrollment 100
Condition
Intervention

Intervention Type: Other

Intervention Name: Blood flow restriction training

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

Arm Group Label: BFRT with 4 exercises and low resistance loads

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)

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Frank R Noyes, MD Principal Investigator Cincinnati Sportsmedicine Research and Education Foundation
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Cincinnati Sportsmedicine and Orthopaedic Center
Location Countries

United States

Verification Date

2022-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cincinnati Sportsmedicine Research and Education Foundation

Investigator Full Name: Sue Barber-Westin

Investigator Title: Director Clinical Studies

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: BFRT with 4 exercises and low resistance loads

Type: Experimental

Description: 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.

Acronym BFRT
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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