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BFRT for Severe Lower Extremity Muscle Atrophy (BFRT)

Primary Purpose

Severe Muscle Atrophy, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood flow restriction training
Sponsored by
Cincinnati Sportsmedicine Research and Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Muscle Atrophy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cincinnati Sportsmedicine and Orthopaedic Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BFRT with 4 exercises and low resistance loads

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2020
Last Updated
February 15, 2022
Sponsor
Cincinnati Sportsmedicine Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04357184
Brief Title
BFRT for Severe Lower Extremity Muscle Atrophy
Acronym
BFRT
Official Title
Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cincinnati Sportsmedicine Research and Education Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Muscle Atrophy, Muscle Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFRT with 4 exercises and low resistance loads
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Blood flow restriction training
Intervention Description
BFRT is done with 4 exercises with low load resistance of 30% 1 repetition maximum
Primary Outcome Measure Information:
Title
Isometric quadriceps and hamstrings muscle strength
Description
Isometric knee flexor and extensor strength will be measured with an isokinetic dynamometer before training and after each series of 9 training sessions
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
Secondary Outcome Measure Information:
Title
Patient rating
Description
Patients will rate the intensity of muscle burn produced during training and overall satisfaction with the final result
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank R Noyes, MD
Organizational Affiliation
Cincinnati Sportsmedicine Research and Education Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Sportsmedicine and Orthopaedic Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

BFRT for Severe Lower Extremity Muscle Atrophy

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