Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03364647 |
| Other study ID # |
15-0750-F6A |
| Secondary ID |
R01AR071398 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 21, 2017 |
| Est. completion date |
October 6, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
University of Kentucky |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 ΒΌ 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.
