Clinical trial NCT04357184: BFRT for Severe Lower Extremity Muscle Atrophy
Official title: Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Muscle Atrophy
Muscle Weakness
Lead sponsor: Cincinnati Sportsmedicine Research and Education Foundation
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Isometric quadriceps and hamstrings muscle strength
timeFrame: 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 outcomes:
measure: Patient rating
timeFrame: 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.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Sportsmedicine and Orthopaedic Center
state: Ohio
Study officials:
affiliation: Cincinnati Sportsmedicine Research and Education Foundation
name: Frank R Noyes, MD
role: PRINCIPAL_INVESTIGATOR
References: