PLAIN LANGUAGE STATEMENT AND CONSENT FORM
TO: Participants
Plain Language Statement
Date: 06/09/13
Full Project Title: The effects of leg resistance training with blood-flow restriction
on unrestricted exercising arms: A pilot study.
Principal Researcher(s): Dr Stuart Warmington, Assoc. Prof Aaron Russell
Student Researcher: Mr Anthony May
This Plain Language Statement and Consent Form is 13 pages long. Please make sure
you have all the pages.
1. Your Consent
You are invited to take part in this research project, which is comprised of a single
study that forms the basis of a PhD project to investigate the effects of resistance
training combined with blood-flow restriction on muscle strength and size. This Plain
Language Statement contains detailed information about this research study in
which you can be involved. Its purpose is to explain to you as openly and clearly as
possible all the procedures involved in these studies before you decide whether or
not to take part.
Please read this Plain Language Statement carefully. Feel free to ask questions about
any information in the document. You may also wish to discuss the project with a
relative or friend or your local health worker. Feel free to do this. Once you
understand what the project is about and if you agree to take part in the study, you
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will be asked to sign the Consent Form. By signing the Consent Form, you indicate
that you understand the information and that you give your consent to participate.
You will be given a copy of the Plain Language Statement and Consent Form to keep
as a record.
2. Purpose and Background
Blood flow restriction exercise is a technique that results in reduced blood flow to
muscles during exercise. This technique is used extensively in Japan where it is
known as Kaatsu. Briefly, this technique requires a pressure cuff to be placed around
an exercising muscle group. The cuff is then inflated to a point whereby blood flow is
reduced. Participants then perform an exercise protocol at 20-30% of the largest
weight they can lift (one repetition maximum – 1 RM) for 15-30 repetitions.
Recent evidence suggests that when light-load strength training protocols are
combined with blood-flow restriction, the gains in muscle strength and size may be
as great as those for traditional heavy-load strength training. However, it is unclear
why these adaptations occur.
Recently, one published study found that by performing light resistance exercise
training in an arm (which is too low to cause gains in muscle strength or size) and
then performing blood-flow restriction training of the legs caused the arm to get
stronger and larger. Therefore, the purpose of this research is to reproduce the
outcomes of this previous research and to test whether these outcomes are
repeatable and consistent.
This project has important implications for our understanding of the requirements to
improve muscle size, strength and function. It also has important implications for “at
risk” populations who require improved muscular strength and functional capacity,
yet are not capable of strength training using heavy loads. Such populations include
those with, or recovering from, muscle-related injuries, and older adults.
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A total of 16 people will participate in this project.
You are invited to participate in this research project because you are a healthy male
adult, aged 18-25 years, physically active with no history of regular strength training
in the last six months, and free from any known musculoskeletal injuries,
neurological injuries, or vascular diseases. You have been provided with this Plain
Language Statement and Consent Form, the Consent Form needs to be completed
and returned before you may be formally accepted to participate in a study. You will
have been instructed about this process in your correspondence with the
researchers.
3. Study outlines
The project consists of a single study occurring for a total of 22 sessions that require
your participation over 8 weeks. All sessions will be undertaken with researcher
supervision and instruction at Deakin University, Burwood.
The first session is a familiarisation session (approximately 90 minutes) that will
begin with an initial screening procedure to ensure you are a suitable participant for
the study. The familiarisation session exists to ensure that you can properly perform
the required training movements and are comfortable and familiar with the testing
equipment. It will also involve tests of muscle size and strength including a onerepetition maximum (1 RM) strength test to determine the training load to be used
in the following training period.
This session will be followed by seven weeks of training (3 days/week) then a last
session to take final measurements of muscle strength and size.
3.1
Testing sessions
Testing sessions (pre and post-training) will measure muscle strength and size. The
pre-training testing will occur as part of the familiarisation session which will take
approximately 90 minutes to complete while the post-training testing session will be
performed following seven weeks of resistance training and will take approximately
70 minutes to complete.
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3.1.1 Muscle size tests
Both pre and post-training testing sessions will start by measuring your leg and arm
circumference with a tape measure, and then muscle size will be measured using
peripheral quantitative computed tomography (pQCT). pQCT is non-invasive and
involves you inserting your arm into the opening of a ring with x-ray source and
detectors, for scanning. This will involve remaining still for three to five minutes
during the measurement. This process will then be repeated with your other arm
then both legs. The pQCT scans will cause no pain or discomfort other than having to
remain still.
3.1.2 Muscle strength tests
Following muscle size measurements, muscle strength of both the arms and legs will
be measured in two ways. First, the maximal isometric strength (i.e. contracting your
muscles as forcefully as you can without moving the joint) of your arms and legs will
be measured using a machine known as a dynamometer. This will require you to
perform three contractions while seated at the dynamometer, pressing against a
level, your limb will be held in a stable position and prevent joint movement while
you contract as forcefully as possible for five seconds. You will be given a 90 second
rest period between each effort for best performance.
Finally, you will be required to perform two single-arm and two double-leg onerepetition maximum (1 RM) tests. The 1 RM test is a measure of the maximal weight
you can lift with one repetition throughout a full range of motion. After a warm-up, a
researcher will guide you to make an estimate on what you believe is your 1 RM
strength, and this load will serve as your starting point. If you successfully lift one
repetition, the weight to lift will be increased for the next single repetition attempt,
if you fail, the load will be reduced accordingly. 1 RM testing with progressively
heavier weights will continue until you reach the heaviest weight that you can lift
with proper technique. You will be supervised and coordinated by a researcher at all
times during this process. You will perform a 1 RM for a single-arm bicep curl on
each arm separately, followed by a double-leg knee extension 1 RM, and then a
double-leg knee flexion 1 RM.
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3.2
Training sessions
You will be required to participate in 20 training sessions over six weeks between
familiarisation and post-training testing. There will be two separate groups in this
study that will perform either BFR or non-BFR exercise and you will be randomly
selected into one or the other. Both groups will be required to begin the session with
a general five minute warm-up then perform bicep curl exercises on the dominant
arm. You will be required to perform ten repetitions of bicep curls at 50% of your
previously determined 1 RM; this will be repeated for three sets with a 3 minute rest
in-between sets. Following this, both groups will be required to perform both
double-leg knee extension and knee-flexion exercises at 30% of their 1 RM. You will
be required to lift the weight for 30 repetitions for the first set then three more sets
of 15 repetitions with 30 seconds of rest between sets. The order of knee-extension
and knee-flexion exercises will alternate for each training session.
The only difference between groups is that the BFR training group will have BFR
applied to their upper legs during the leg exercises using specially designed cuffs.
These cuffs will be inflated to a pressure equal to only 60% of the pressure required
to completely restrict blood-flow. This pressure will be firm and remain continually
applied throughout both leg exercises (approximately 14 minutes total).
Session Type
Number of Sessions
Duration
Familiarisation
1
90 min
Training
20
30 min
Post-training testing
1
70 min
22
12 hr 40 min
Total
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4. Possible benefits
The main purpose of this research is to ensure that results from previous research
can be reproduced. If this is the case then it is assumed that participants in the BFR
group will receive muscle strength and size gains in the legs and also the trained
arm, while the non-BFR group may receive little gains in leg and arm strength. Also,
your participation throughout this study will provide important and valuable
information regarding the benefits of BFR training on muscle strength and size
development, which may go on to benefit the wider community by assisting with the
development of rehabilitation programs or exercise performance.
5. Possible risks
Considering the pre-testing screening, there are no foreseeable risks to your
participation in this study. However, the strength exercises involve a risk of muscle
soreness and stiffness, although this is unlikely due to the type of movements in the
training program and testing sessions.
The moderate cuff pressure (approximately 130 mmHg) combined with the
moderate duration (approximately 14 minutes) of blood flow restriction during
exercise has not been shown to result in any harmful acute or long-term effects. You
may, although it is unlikely, experience dizziness, temporary numbness and slight
discomfort in the occluded areas during exercise. Prior to being accepted into this
study you will answer a series of questions asked by the researcher as part of the
Adult Pre-exercise Screening System (APSS) tool to determine if there are any issues
that may stop you from participating.
The risks involved in this project are minimal because experienced staff will be
conducting the tests using standard procedures. Previous studies in normal
populations have failed to demonstrate health issues following blood-flow restriction
strength training, and muscle tissue has a low oxygen tolerance time of up to four
hours; therefore evidence suggests that blood-flow restriction exercise is not
harmful, even in the long-term.
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This research study involves exposure to a very small amount of radiation from pQCT
scans of your body. As part of everyday living, everyone is exposed to naturally
occurring background radiation and receives a dose of about 2 millisieverts (mSv)
each year. The effective dose you will receive from all the pQCT scans of your body
will be approximately 0.012 mSv. At these dose levels, no harmful effects of
radiation have been demonstrated, as any effect is too small to measure. The risk is
believed to be minimal. If you have been involved in any other research studies that
involve radiation, please inform us. Please keep this Patient Information and Consent
Form that includes information about your exposure to radiation in this study for at
least five years. You will be required to provide this information to researchers of
any future research studies involving exposure to radiation.
You have the right to terminate testing or withdraw from the study at any time
without adverse consequences to yourself or this study, in which case any
information obtained from you will not be used further.
6. Privacy, confidentiality and disclosure of information
Any personal information provided by you to the researchers involved with this
project will remain confidential. It will only be disclosed with your permission,
subject to legal requirements. All individual results will remain strictly confidential
and no names will be used in any publications.
It is the intention of the researchers to publish the results of this project. In such
circumstances your identity will not be disclosed. In all cases, information will be
provided in such a way that you cannot be identified. In addition, any information
collected will be coded and de-identified, and stored securely in electronic format
where only the researchers will have access to the data.
The results of this project will be discussed at national and or international
conferences. In all cases your identity and personal information will not be disclosed.
Information will be provided in such a way that you cannot be identified.
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The Deakin University Human Research Ethics Committee requires that all material
must be kept for a minimum of 6 years to allow reference to interest and discussion.
After a period of six years from the date of publication or public release of the work
of the research, paper copies of the subject's individual responses will be disposed of
in the interests of limiting physical space taken up by the records. Electronic copies
of all data will be retained indefinitely.
7. New information arising during the project
Although unlikely, during the research project, new information about the risks and
benefits of the project may become known to the researchers. If this occurs, you will
be told about this new information. This new information may mean that you can no
longer participate in this research.
Similarly, as you will be monitored during each testing and training session, if it
appears for any reason that you or the research staff are at risk by your continuing
participation in the testing or training session, the person(s) supervising the research
will stop your participation. In all cases, you will be offered all available care to suit
your needs and medical condition.
8. Results of the study
Upon completion of the project the results will be published in Anthony May’s PhD
thesis. It is also possible that the results will be submitted for potential peer review
and journal publication. The results may also be presented during a research
conference.
If you would like a copy of published material arising from the project, you should
request this from the principle researcher (See section 13) at the conclusion of the
project. If you would like data on your own personal results then please request this
and a short report will also be provided at this time.
You will be notified if the project is accepted for publication.
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9. Participation is voluntary
Participation in any research project is voluntary. If you do not wish to take part you
are not obliged to. If you decide to take part and later change your mind, you are
free to withdraw from the project at any stage. Any information obtained from you
to date will not be used and will be destroyed.
Your decision whether to take part or not to take part, or to take part and then
withdraw, will not affect your relationship with Deakin University.
Before you make your decision, a member of the research team will be available to
answer any questions you have about the research project. You can ask for any
information you want. Sign the Consent Form only after you have had a chance to
ask your questions and have received satisfactory answers.
If you decide to withdraw from this project, please notify a member of the research
team or complete and return the Revocation of Consent Form attached. This notice
will allow the research team to inform you if there are any health risks or special
requirements linked to withdrawing.
10. Ethical guidelines
This project will be carried out according to the National Statement on Ethical
Conduct in Human Research (2007) produced by the National Health and Medical
Research Council of Australia. This statement has been developed to protect the
interests of people who agree to participate in human research studies.
The ethical aspects of this research project have been approved by the Human
Research Ethics Committee of Deakin University under project number
HEAG-H 2013-296.
11. Reimbursement for your costs
You will not be reimbursed for your participation in this project.
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12. Complaints
If you have any complaints about any aspect of the project, the way it is being
conducted or any questions about your rights as a research participant, then you may
contact:
The Manager, Office of Research Integrity, Deakin University, 221 Burwood Hwy,
Burwood, VIC 3125, Telephone: (03) 9251 7129, Facsimile: 9244 6581; researchethics@deakin.edu.au
Please quote this project number HEAG-H 2013-296.
13. Further information, queries or any problems
If you require further information, wish to withdraw your participation or if you have
any problems concerning this project (for example, any side effects), you can contact
the principal researcher. The researchers responsible for this project are:
Student Researcher:
Principle Researcher (Supervisor):
Principle Researcher
Mr Anthony May
School of Exercise and Nutrition
Sciences
Deakin University
221 Burwood Hwy, Burwood, VIC
3125
Mobile: 0416 913 814
Fax: +61 3 9244 6017
Email:
akmay@deakin.edu.au
Dr Stuart Warmington
School of Exercise and Nutrition
Sciences
Deakin University
221 Burwood Hwy, Burwood, VIC
3125
Telephone: +61 3 9251 7013
Fax: +61 3 9244 6017
Email:
stuart.warmington@deakin.edu.au
(Associate Supervisor):
Assoc. Prof Aaron Russell Centre for
Physical Activity and Nutrition
Research
School of Exercise and Nutrition
Sciences
Deakin University
221 Burwood Hwy, Burwood, VIC
3125
Telephone: +61 3 9251 7397
Fax: +61 3 9244 6017
Email:
aaron.russell@deakin.edu.au
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PLAIN LANGUAGE STATEMENT AND CONSENT FORM
TO: Participants
Consent Form
Date:
Full Project Title: The effects of leg resistance training with blood-flow restriction
on exercising arms: A pilot study
Reference Number:
I have read and I understand the attached Plain Language Statement.
I freely agree to participate in this project according to the conditions in the Plain
Language Statement.
I have been given a copy of the Plain Language Statement and Consent Form to
keep.
The researcher has agreed not to reveal my identity and personal details, including
where information about this project is published, or presented in any public form.
I also agree to have my individual results regarding the study stored at Deakin
University for six years after the (expected) publication of the project while
electronic copies will be stored indefinitely, and I understand that it will remain
protected and confidential during this time.
I understand that the project will involve my participation in twenty sessions and full
participation is required for my results to be viable yet I am aware that I am free to
withdraw from the study at any stage without being subject to any repercussions for
doing so.
Participant’s Name (printed) ……………………………………………………………………
Signature ………………………………………………………
Date …………………………
Please return to Dr Stuart Warmington
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Hwy, Burwood, VIC 3125
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PLAIN LANGUAGE STATEMENT AND CONSENT FORM
TO: Participants
Withdrawal of Consent Form
(To be used for participants who wish to withdraw from the project)
Date:
Full Project Title: The effects of leg resistance training with blood-flow restriction
on exercising arms: A pilot study
Reference Number:
I hereby wish to WITHDRAW my consent to participate in the above research project
and understand that such withdrawal WILL NOT jeopardize my relationship with
Deakin University.
Participant’s Name (printed) …………………………………………………….
Signature ………………………………………………………………. Date ……………………
Please mail or fax this form to:
Dr Stuart Warmington
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Hwy, Burwood, VIC 3125
Telephone: +61 3 9251 7013
Fax: +61 3 9244 6017
Email: stuart.warmington@deakin.edu.au
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