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Completed

NCT Number: NCT04357184

BFRT 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.

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Key information

Conditions

Severe Muscle Atrophy Atrophy Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, 45242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood Flow Restriction training

Other

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

Primary outcomes

  1. Isometric quadriceps and hamstrings muscle strength

    Time frame: 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

    Isometric knee flexor and extensor strength will be measured with an isokinetic dynamometer before training and after each series of 9 training sessions

Secondary outcomes

  1. Patient rating

    Time frame: 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.

    Patients will rate the intensity of muscle burn produced during training and overall satisfaction with the final result

Sponsors and collaborators

Lead sponsor

Cincinnati Sportsmedicine Research and Education Foundation

Other

Registry information

Official study title

Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy

Acronym: BFRT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2020
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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