Blood Flow Restriction Training in Rehabilitation Patients

NCT02174770 | Terminated

• 2 other identifiers: 395166397709
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Occlusion training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle at low resistance and minimal stress on the nearby joint. This novel resistance training has the potential to greatly improve extremity muscle strength gains for rehabilitation patients who are unable for medical reasons to perform high resistance exercise. Our study will explore this with specific rehabilitation populations: post-operative knee scopes, post-operative anterior cruciate ligament (ACL) reconstruction patients who have acute post-operative changes in thigh muscle function and chronic thigh weakness. The primary outcome is to achieve accelerated functional thigh recovery with outcome measures including thigh strength, validated questionnaires, and validated functional testing. Occlusion training can enhance rehab patients outcomes, reduce the cost of care, and improve the skills and efficiency of care providers.

Conditions

Anterior Cruciate Ligament Reconstruction; Volumetric Muscle Loss; Chronic Thigh Muscle Weakness; Knee Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Thigh Muscle Strength

  6 weeks

Study Arms (5)

ACL BFR group

EXPERIMENTAL

This group is patients with post-op from ACL reconstruction who are randomized into the blood flow restriction arm. They will receive BFR strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

Other: Blood Flow Restriction (BFR) Training

ACL Standard Therapy

ACTIVE COMPARATOR

This group is patients with post-op from ACL reconstruction who are randomized into the standard therapy arm. They will receive ACSM guided-strength training as part of their post-operative physical therapy program.

Other: Standard ACSM-guided strength training

Chronic Muscle Weakness

OTHER

This is a crossover group where all subjects will be randomized to begin with either standard or blood flow restriction therapy for 4 weeks. After completion of the initial training, each subject will be switched to the opposite in an AB/BA crossover design.

Other: Blood Flow Restriction (BFR) Training; Other: Standard ACSM-guided strength training

Knee Arthroscopy BFR

EXPERIMENTAL

This group is patients with post-op from soft-tissue only knee arthroscopy who are randomized into the blood flow restriction arm. They will receive BFR strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

Other: Blood Flow Restriction (BFR) Training

Knee Arthroscopy Standard

ACTIVE COMPARATOR

This group is patients with post-op from soft-tissue only knee arthroscopy who are randomized into the standard physical therapy arm. They will receive ACSM-guided strength training as part of their post-operative physical therapy program during normal post-op rehab.

Other: Standard ACSM-guided strength training

Interventions

Blood Flow Restriction (BFR) Training OTHER

This is a modality of physical therapy where during low-load resistance activity, the venous return of blood from an extremity is limited only during the duration of the exercise. This can be accomplished through multiple means. For the purposes of our study, we will use an inflatable tourniquet.

Also known as: Low resistance training, Occlusion training

ACL BFR group; Chronic Muscle Weakness; Knee Arthroscopy BFR

Standard ACSM-guided strength training OTHER

This is the standard protocol to be used for post-operative and other physical therapy patients for rehabilitation. It includes the use of American College of Sports Medicine-guidelines for how much weight to use during the strength training portion of the rehabilitation.

Also known as: physical therapy

ACL Standard Therapy; Chronic Muscle Weakness; Knee Arthroscopy Standard

Eligibility Criteria

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

You may qualify if:

• One of the following: (1) s/p ACL reconstruction within the last three months prior to initiation of study training, (2) s/p knee arthroscopy within the last 2 weeks prior to initiation of study training, (3) S/p lower extremity trauma, unilateral with thigh weakness of at lest a 20% deficit compared to contralateral side and at least 6 months out from most recent trauma or surgery
• Fluent in English and able to consent

You may not qualify if:

• Contralateral lower extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 5/10.
• Pregnancy, verbal reporting
• Recent history of deep vein thrombosis, within the 12 months or on active treatment
• History of endothelial dysfunction, peripheral vascular disease, hypertension, diabetes, or people prone to capillary ruptures (bruising) (determined by verbal reporting by the patient)
• Active Infection
• Cancer (current diagnosis)

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Center for the Intrepid

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Interventions

Blood Flow Restriction Therapy; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery Resident

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

US (2)