BFRT for Severe Lower Extremity Muscle Atrophy

NCT04357184 | Completed

• 1 other identifier: BFRT17-37
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Muscle Atrophy; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

BFRT with 4 exercises and low resistance loads

EXPERIMENTAL

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.

Other: Blood flow restriction training

Interventions

Blood flow restriction training OTHER

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

BFRT with 4 exercises and low resistance loads

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cincinnati Sportsmedicine Research and Education Foundation: lead

Study Sites (1)

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Muscular Atrophy; Muscle Weakness

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Frank R Noyes, MD

  Cincinnati Sportsmedicine Research and Education Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Studies

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 22, 2020
• Study Start: April 14, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)