BFRT for Severe Lower Extremity Muscle Atrophy

Muscle Weakness Clinical Trial

— BFRT  

Official title:

Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357184
• Other study ID #: BFRT17-37
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: February 2022
• Source: Cincinnati Sportsmedicine Research and Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Muscle Weakness
• Muscular Atrophy
• Severe Muscle Atrophy

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Sportsmedicine and Orthopaedic Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cincinnati Sportsmedicine Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.