CONSENT FORM FOR PARTICIPANTS
INVOLVED IN RESEARCH
INFORMATION TO PARTICIPANTS:
We would like to invite you to be a part of a study into the….
The use of Transcutaneous Electrical Nerve Stimulation (TENS) to reduce the perceptions of fatigue in exercise.
Prior to taking part in this study, all participants will be required to complete a Risk Factor Assessment Questionnaire, which will identify those with suspected cardiovascular complications, ventilatory
restrictions and/or musculoskeletal conditions or injuries. This questionnaire will help to minimise the risk of physical complications, if you do not pass this process you will not be included in this research.
Project explanation
This project aims to examine the use of transcutaneous electrical nerve stimulation (TENS) to reduce the perceptions of fatigue and therefore influence performance in exercise. TENS is a method of low-voltage electrical currents to the skin via surface electrodes commonly used for the treatment of chronic and acute pain.
All exercise naturally involves a level of discomfort associated with fatigue (i.e. fatigue induced soreness), this information is important in determining exercise performance. Investigation into exercise has established that fatigue and the associated responses can be identified as a negative emotion in an individual’s sense of effort. Essentially performance is determined by the level of negative emotions (discomfort) an individual is willing to encounter. Therefore, the use of TENS in this setting is planned to be used to ‘mask’ the sensations and therefore the perception of fatigue during a cycling time trial. Prior to taking part in this study, all participants will be required to complete a risk factor assessment questionnaire, which will identify any issues that may influence your ability to participate. This questionnaire will help to minimise the risk of physical complications, if you do not pass this process you will not be included in this research.
If you choose to volunteer, you will be randomly allocated to one of two groups either TENS application during exercise (TENSduring) or TENS application prior to exercise (TENSprior). You will be required for six sessions (approximately 1.5 hour each). This will involve one familiarisation to the exercise protocol, familiarisation to the maximal voluntary contraction and magnetic stimulation and familiarisation to TENS, one familiarisation session to the exercise protocol, one pre testing session for baseline testing and three experimental testing sessions which involve a control (no TENS application), and two intervention (TENS application) sessions.
Before you volunteer to this study, make sure you read carefully the items below:
1. You are free to withdraw from this study at any time without any consequences or need for explanation
2. There is a slight chance you will experience discomfort associated with the TENS, any discomfort will be quickly disappear following the removal of stimulation. If you feel at any stage that the discomfort associated with any technique is unbearable you can choose to withdraw from the research.
3. You are required to complete a risk factor questionnaire. It is important to be truthful as this will help researchers determine if participating in this study is appropriate for you.
4. All exercise sessions involve risks of fainting, soft-tissue injury, muscle soreness and stiffness. The risk of such events is relatively low.
5. All exercise activity carries a risk of injury and risks of suffering a heart attack or stroke. It is important that you tell us if you have any medical condition.
6. For any medical emergencies a call to 000 will be made. The researchers will also commence appropriate first aid methods while waiting for the emergency team to arrive.
7. Furthermore, the exercise protocols involve the possibility for mood changes such as irritability and depression. To minimise the risk of any psychological stress, your results will remain confidential. If you become stressed as a result of your participation please feel free to consult Professor Tony Morris a registered psychologist, who is not involved in the study but knows about it on (03) 9919 5353 or at [email protected] (free of charge).
CERTIFICATION BY SUBJECT
I, (name)
of
(address/suburb)
Certify that I am at least 18 years old and that I am voluntarily giving my consent to participate in the study: “Use of Transcutaneous Electrical Nerve Stimulation (TENS) to reduce the perceptions of fatigue in exercise.”
Which is being conducted at Victoria University by: Andrew Hibbert
I certify that the objectives of the study, together with any risks and safeguards associated with the procedures listed hereunder to be carried out in the research, have been fully explained to me by: Mr. Andrew Hibbert and that I freely consent to participation involving the below mentioned procedures:
5-km Time-Trials Graded exercise test
Pressure Algometry EMG
Maximal Voluntary Contraction Peripheral Magnetic Stimulation
Responses to scales and Questionnaires:
- Rate of Perceived exertion (RPE)
- Feeling Scale (FS)
- Sense of Effort (SE)
- Skeletal Discomfort (SD)
- Questionnaire about exercise
I certify that I have had the opportunity to have any questions answered and that I understand that I can withdraw from this study at any time and that this withdrawal will not jeopardise me in any way.
I have been informed that the information I provide will be kept confidential. Signed:
Date:
Any queries about your participation in this project may be directed to the researchers
Dr. Matthew Varley ph: (03) 9919 5275 email:
Mr. Andrew Hibbert mob: 0400772879 email:
[email protected] Professor Remco Polman
If you have any queries or complaints about the way you have been treated, you may contact the Ethics Secretary, Victoria University Human Research Ethics Committee, Office for Research, Victoria University, PO Box 14428, Melbourne, VIC, 8001 or phone (03) 9919 4781.