Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Isometric quadriceps and hamstrings muscle strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- 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.)
Investigators
Sue Barber-Westin
Director Clinical Studies
Cincinnati Sportsmedicine Research and Education Foundation