Participant Information Form
The effect of osteopathic manual therapy with breathing re-training on
dysfunctional breathing, exercise economy and the autonomic nervous
system
You are invited to take part in this study, which investigates ‘The effect of osteopathic
manual therapy with breathing re-training on symptoms of dysfunctional breathing,
exercise economy and heart rate variability in active adults’. Whether or not you take
part is your choice. If you don’t want to take part, you don’t have to give a reason. If you
plan to or are currently receiving osteopathic care, your decision won’t affect the care
you receive. If you do want to take part now, but change your mind later, you can
withdraw from the study at any time up until two weeks after your participation in the
project.
This Participant Information Sheet will help you decide if you’d like to take part. It sets out
why we are doing the study, what your participation would involve, what the benefits and
risks to you might be, and what would happen after the study ends. We will go through
this information with you and answer any questions you may have. You do not have to
decide today whether or not you will participate in this study. Before you decide you may
want to talk about the study with other people, such as family, whānau, friends, or
healthcare providers. Feel free to do this.
If you agree to take part in this study, you will be asked to sign the Consent Form on the
last page of this document. If this has been emailed to you, you don’t need to print it out.
You will be given a copy of the Consent Form to sign at the beginning of your first
familiarization visit.
This document is 5 pages long, including the Consent Form. Please make sure you have
read and understood all the pages.
UREC REGISTRATION NUMBER: 2013-XXXX
This study has been approved by the UNITEC Research Ethics Committee from XX.X.XX to
XX.X.XX If you have any complaints or reservations about the ethical conduct of this research, you
may contact the Committee through the UREC Secretary (ph: 09 815-4321 ext 7248). Any issues you
raise will be treated in confidence and investigated fully, and you will be informed of the outcome.
What is the purpose of the study?
The primary aim of this study is to determine the effectiveness of osteopathic manual
treatment in improving symptoms and signs of dysfunctional breathing and in altering the
energy required during exercise to get oxygen to the muscles. Secondly, any relationship
between changes in symptoms and energy required to get oxygen to the muscles will be
explored. Thirdly, any relationship between Dysfunctional breathers and cardiac
autonomic regulation. Fourthly, to investigate the relationship between cardiac autonomic
regulation measuring tools (heart rate recovery, heart rate variability and heart rate).
Finally if the combined intervention of osteopathic manual treatment and breathing retraining has an effect on changing the autonomic nervous system.
What will my being in the study involve?
You will receive a series of four, weekly osteopathic treatments from a registered
osteopath. Prior to these treatments you will be required to undergo a familiarization
session at the human performance lab to ensure comfort with the testing equipment that
will be used during the study. This familiarization session will take between 1 – 2 hours
and will include an assessment of physical fitness. After familiarization you will be asked
to undergo either two or three sessions in the human performance lab following the same
procedure but without the fitness assessment.
Measurements taken in the familiarization session and testing sessions will include:
 Non-exhaustive assessment of your fitness
 Heart rate
 Lung function (spirometry)
 Oxygen Uptake Assessment (VO2)
 Breath Carbon Dioxide (CO2)
 Your Perception of Exercise Intensity (perceived exertion)
 Mechanical Lung Expansion
 Dysfunctional Breathing via Questionnaires
 Heart rate recovery
 Heart rate Variability
UREC REGISTRATION NUMBER: 2013-XXXX
This study has been approved by the UNITEC Research Ethics Committee from XX.X.XX to
XX.X.XX If you have any complaints or reservations about the ethical conduct of this research, you
may contact the Committee through the UREC Secretary (ph: 09 815-4321 ext 7248). Any issues you
raise will be treated in confidence and investigated fully, and you will be informed of the outcome.
On the day of these sessions you are asked to refrain from any sports or exercise, which
is required for the measuring of resting heart rate variability. During these sessions resting
heart rate variability will be recorded after a 5 minute rest period in the semi sucumbent
position, oxygen uptake will be assessed under sub-maximal exercise conditions. Post
exercise cessation you will be required to sit down for 5 minutes, during this time heart
rate recovery and post exercise heart rate variability will be recorded. Each session will
however only take about 1 hour due to your familiarity with the equipment and procedure.
You may receive one or two sessions prior to treatment, as we are simultaneously running
a reliability study of the measurements we are using in this study. Scheduling of these
sessions is dependent on laboratory availability. After treatment, you will be required to
undergo one more laboratory session following the aforementioned procedure, which
again, will take around 1 hour.
For the first treatment session, the consultation will be slightly longer (40 – 60 minutes)
than subsequent treatments (20 – 30 minutes). The practitioner will be a registered
osteopath who is currently practicing. During the first consultation, the practitioner will take
a detailed case history and relevant medical information from you. Treatment will involve
the practitioner examining and treating any structures on the trunk or attaching to the trunk
that are moving inappropriately. Notes will be taken during treatment, which can only be
viewed by the practitioner, researcher, research supervisor and yourself. Following each
treatment, you will receive breathing retraining advice by the researcher. This session will
take around 10 – 15 minutes.
Who pays for the study?
As a participant, you will not incur any costs for treatment or laboratory testing. These
costs will be covered by the researcher and any funding they receive.
What if something goes wrong?
The perceived risk of harm while participating in this study is low and measures have
been made to ensure the safety of participants. For this reason it is important to allow
the practitioner to take an accurate and relevant medical history.
UREC REGISTRATION NUMBER: 2013-XXXX
This study has been approved by the UNITEC Research Ethics Committee from XX.X.XX to
XX.X.XX If you have any complaints or reservations about the ethical conduct of this research, you
may contact the Committee through the UREC Secretary (ph: 09 815-4321 ext 7248). Any issues you
raise will be treated in confidence and investigated fully, and you will be informed of the outcome.
However, if you were injured in this study, you would be eligible for compensation from
ACC just as you would be if you were injured in an accident at work or at home. You will
have to lodge a claim with ACC, which may take some time to assess. If your claim is
accepted, you will receive funding to assist in your recovery.
If you have private health or life insurance, you may wish to check with your insurer that
taking part in this study won’t affect your cover.
What happens to data from the study?
You have the right to access information collected from you as part of the study. Study
results will be anonymised and not reported in a way that could result in identification of
individuals. Only the primary researchers and research supervisors will have access to
individual information.
What are my rights?
You are participating in this research voluntarily and free to decline to participate or
withdraw from the research at any time up to two weeks after your participation in the
study, without experiencing any disadvantage.
UREC REGISTRATION NUMBER: 2013-XXXX
This study has been approved by the UNITEC Research Ethics Committee from XX.X.XX to
XX.X.XX If you have any complaints or reservations about the ethical conduct of this research, you
may contact the Committee through the UREC Secretary (ph: 09 815-4321 ext 7248). Any issues you
raise will be treated in confidence and investigated fully, and you will be informed of the outcome.
Participant Consent Form
The effect of osteopathic manual therapy with breathing re-training on
dysfunctional breathing, exercise economy and the autonomic nervous
system
Name of Participant: _____________________________________________________
I have seen and read the information sheet for participants taking part in the project titled
“The effect of osteopathic manual therapy with breathing re-training on
dysfunctional breathing, exercise economy and the autonomic nervous system”
and have had the opportunity to discuss the project with the study researcher.
I understand that I am volunteering to partake in this study of my own volition, and I may
withdraw at any time up until two weeks after my participation in the research project.
I understand that if I am to suffer an accident or injury while participating in any part of this
project that I will be entitled to make a claim under the Accident Compensation scheme.
I understand that my participation in this project is confidential and that no material that
could personally identify me will be used in any reports on this project.
I understand that I can see the finished research document.
I have had enough time to consider whether I want to take part and acknowledge that any
data collected during the study will be stored securely so that only the researchers may
access them.
Participant Signature: _________________________
Date:________________
The principal researchers for this project is Lacey Barnett and Jordan Benjamin, principal
supervisor is Catherine Bacon:
Lacey Barnett
Tel: 0276993988
Email: lacebarney@hotmail.com
Jordan Benjamin
Tel: 0223445331
Email: JordanAotearoa@gmail.com
Catherine Bacon
Tel: 815-4321 ext. 7709
Email: cbacon@unitec.ac.nz
The participant should retain a copy of this consent form
UREC REGISTRATION NUMBER: 2013-XXXX
This study has been approved by the UNITEC Research Ethics Committee from XX.X.XX to
XX.X.XX If you have any complaints or reservations about the ethical conduct of this research, you
may contact the Committee through the UREC Secretary (ph: 09 815-4321 ext 7248). Any issues you
raise will be treated in confidence and investigated fully, and you will be informed of the outcome.