The Effect of Various Strength Training Protocols in ACL Reconstructed Participants

The Effect of Various Strength Training Protocols in ACL Reconstructed Participants



Sponsors

Lead Sponsor



Source

University of Kentucky

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

The purpose of the study is to determine how two different blood flow restriction training
programs used in conjunction with standard rehabilitation affect leg strength. By doing this
study, the investigator hopes to learn if one program improves strength and function more
than the other. The investigator also hope to learn how the training affects the properties
of muscle in participants who will or have had anterior cruciate ligament (ACL)
reconstruction. These results will help define how the training programs are working.

There will be no charge to the participant for their physical therapy visits as long as they
are part of the study

The initial visit and follow up assessment at the end of the training will each take up to 6
hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and
questionaires).

The physical therapy visits will range from 60-120 minutes depending on the participant's
stage of recovery and the activities to engage in. Training sessions will be held 3 days a
week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be
a total of 4 additional study visits over a 7 month period. The first visit will be used to
capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength).
The second visit will occur right before surgery to assess changes during prehabilitation
(strength and walking mechanics). The third visit will occur 4-5 months after surgery and
will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI,
strength, gait). The last visit will occur 6-7 months after surgery and will involve an
assessment of their thigh muscle strength, walking, and jumping form.

The muscle biopsy and magnetic resonance imaging portion of the study will occur in the
outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center
and the MRI center located on the medical center campus. The muscle biopsy will take an
additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours
total to complete both procedures. The investigator will accommodate participant preference
for scheduling.

Detailed Description

The following procedures may be performed.

Training sessions: Participants will be randomly assigned one of two groups. Assignments to
which group are determined by random assignment based upon participant's number. One group
will receive standard of care and the other will receive standard of care plus blood flow
restriction training.

The air bands will then be placed on the participant's thighs and they will be doing a
standardized exercise program that will vary depending on the stage of rehabilitation they
are in and as determined by the study personnel. Participants will also complete a
standardized course of physical therapy. Activities in physical therapy may include ice over
the knee, range of motion exercises to maintain hip strength and gait training exercises as
needed and as the participant's impairments dictate. The investigator will also provide an
educational program at regular intervals on the injury and recovery.

Quadriceps strength: Participants will sit in a seated position and a stabilizing strap will
be placed around the thigh. A second strap will be placed around the bottom of their lower
leg and attached to the isokinetic dynamometer (a muscle strength testing device) which will
control movements and apply force at several different speeds and in a isometric mode.

Motion Analysis: Motion analysis will provide a means for evaluating motion of the
participant's hip, knee and ankle joints during walking and jogging on the treadmill.
Participants will have reflective markers placed on certain landmarks of their legs and lower
back to allow the motion analysis system to record their trunk, hip, knee, and ankle
movements. Markers will be applied with sticky tape to the skin and if necessary, athletic
tape to limit marker movement during activities. A stationary trial will be collected to help
the researcher identify anatomical landmarks. Motion data will be collected for 10 seconds
every minute. Participants will perform a series of jumps on both legs and on a single leg.
In addition participants will be asked to go up and down step.

Treadmill Activity: Participants may walk on the treadmill as long as necessary to feel
comfortable with it. Once ready, participants will walk at a self-selected warm up pace for 5
minutes. The investigator will then gradually increase the speed 1.5 m/s for 2 minutes each.
The speed of the treadmill will then be increased gradually to a self-selected comfortable
jogging\running pace for 2 minutes. Participants may request to stop at any time.

Muscle Biopsy: A small piece of muscle tissue will be removed from both of thighs. The muscle
tissue will be taken from the outside of your thigh and will be taken about one hand width
above your knee. A 1 inch by 1 inch portion of hair will possibly need to be shaved if
necessary. The area of thigh will be numbed and a small ¼ inch incision will be made in the
skin. A needle will then be briefly (lasting just a couple of seconds) inserted into the
muscle to remove a .005 ounce piece of muscle (about the size of a pencil eraser). The
incision will be pulled closed with a band-aid after the site is cleaned with an alcohol
preparation and the participant's leg will be wrapped snugly with an elastic bandage. The
procedure will last approximately 15 minutes. The tissue samples will be used in the analysis
process. In addition, standard venipuncture methods will be used to collect one 7.5 mL tube
of blood to be used for analysis.

Magnetic Resonance Imaging & Spectroscopy Center: Participants will be asked to complete a
medical screening questionnaire that will ask specific questions about their health and
medical history. This information will be used to determine eligibility to participate in the
study. At this time, the procedures and risks involved in participating in the research study
will be explained to the individual. Participants will also fill out a questionnaire asking
whether they have any metal in their body as well as any other medical conditions that may
need to be considered before they enter the MRI scanner. The metal screening questionnaire
will be reviewed by the individual operating the scanner and if any risks are identified, the
participant may not be able to participate.

Participants will be taken to the MRI scanner by the experimenter. Participants will be asked
to remove all jewelry, body piercings, hair accessories, belts, wallets, credit cards, and
loose change and leave these items with the experimenter. Participants will then be
instructed about specific MRI procedures.

The magnetic resonance scanning will take approximately 60 minutes per leg. Participants will
be asked to lie still during the scanning.

Overall Status

Recruiting

Start Date

2017-08-21

Completion Date

2022-12-31

Primary Completion Date

2022-12-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Measure change in quadriceps strength after using BFRT for treatment in patients who will have an ACL reconstruction.
Before surgery, 4 months after surgery and 6 months after surgery

Secondary Outcome

Measure

Time Frame

Measure change in quadriceps muscle morphology after using BFRT for treatment in patients who will have an ACL reconstruction.
Before surgery, 4 months after surgery
Measure change in knee biomechanics after using BFRT for treatment in patients who will have an ACL reconstruction.
Before surgery, 4 months after surgery and 6 months after surgery

Enrollment

60

Conditions


Intervention

Intervention Type

Other

Intervention Name


Description

Group receive standard of care plus blood flow restriction training

Arm Group Label

Arm A - Blood flow restriction training


Intervention Type

Other

Intervention Name


Description

Group will receive standard of care plus a sham version of blood flow restriction training

Arm Group Label

Arm B - standard of care plus sham



Eligibility

Criteria

Inclusion Criteria:

- ACL tear and no previous ACL reconstruction on either the involved or other limb

Exclusion Criteria:

- Previous surgeries or conditions that might affect gait

- Any current condition other than ACL or meniscus injury which might affect gait

- Unable to provided informed consent

- Diabetic or have uncontrolled hypertension

- Have recent inflammation, bleeding disorders, active bleeding or infection within the
lower limbs.

- Allergic to Betadine or Xylocaine HCL.

- Taking warfarin/Coumadin, clopidogrel/Plavix, Rivaroxaban/Xarelto, Dabigatran/Pradaxa
that may cause excess bleeding.

- Any implanted medical device

- A history of deep vein thrombosis, have a family history of deep vein thrombosis, or
varicose veins

- Spinal fusion

- Inability able to attend regular physical therapy or study visits

- Injury occurring more than ten weeks prior to study enrollment

- Not skeletally mature (growth plates not closed)

Gender

All

Minimum Age

15 Years

Maximum Age

40 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Brian Noehren, PT., Ph.D
Principal Investigator
University of Kentucky

Overall Contact

Last Name

Brian Noehren, PT., Ph.D.

Phone

859-218-0581

Email



Location

Facility

Status

Contact

University of Kentucky Orthopaedics and Sports Medicine Center
Lexington Kentucky 40504 United States
Recruiting
Last Name: Cale Jacobs, PhD
Phone: 859-218-0839
Email: [email protected]
University of Kentucky BioMotion Laboratory, 725 Rose Street
Lexington Kentucky 40536-0082 United States
Not yet recruiting
Last Name: Brian Noehren, MD
Phone: 859-218-0581
Email: [email protected]

Location Countries

Country

United States


Verification Date

2017-11-01

Lastchanged Date

2017-11-30

Firstreceived Date

2017-11-15

Responsible Party

Responsible Party Type

Sponsor-Investigator

Investigator Affiliation

University of Kentucky

Investigator Full Name

Brian W. Noehren

Investigator Title

Principal Investigator


Has Expanded Access

No

Number Of Arms

2

Arm Group

Arm Group Label

Arm A - Blood flow restriction training

Arm Group Type

Experimental

Description

Group will use blood flow restriction training and standard of care


Arm Group Label

Arm B - standard of care plus sham

Arm Group Type

Sham Comparator

Description

Group will receive standard of care plus a sham version of blood flow restriction training



Firstreceived Results Date

N/A

Other Outcome

Measure

Measure the change in muscle physiology after using BFRT for treatment in patients who will have an ACL reconstruction.

Time Frame

Before surgery, 4 months after surgery

Description

Muscle biopsy, which may include immunohistochemistry, histochemistry, protein expression, gene expression, or single fiber morphology may be measured. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Parallel assignment

Primary Purpose

Treatment

Masking

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

Participants, outcomes assessors, and the PI will be blinded as to the participant's group assignment.


Study First Submitted

November 15, 2017

Study First Submitted Qc

November 30, 2017

Study First Posted

December 6, 2017

Last Update Submitted

November 30, 2017

Last Update Submitted Qc

November 30, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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