School of Psychology and Exercise Science 90 South Street Murdoch, WA, 6153 www.murdoch.edu.au Information Letter Strength Training on Neuromuscular-Biomechanical Outcomes in Adults with Medial Knee Osteoarthritis Propose Prevention and management of Arthritis/Osteoarthritis is one of nine National Health Priorities. Regular exercise is considered one of the most effective treatments for arthritis, with guidelines recommending muscle strengthening as suitable treatment option. However, more research is needed to identify the best exercise prescription for maximal benefits. The aim of this study is: 1) To identify the effects of strength-training, on promoting improved balanced activation between the muscles on the inside and outside of the leg, 2) To examine the effects of a strength-training program on muscle activity and how these changes relate to pain, function and knee-joint loading. This research looks to provide a better understanding into the function of specific muscles in patient’s knee osteoarthritis, to improve load distribution, thereby assisting practitioners in prescribing efficient exercises strategies in treating symptoms and preventing knee osteoarthritis. What Does Your Participation Involve? If you are interested in partaking in this study, you will need to complete medical history questions, the Knee Injury and Osteoarthritis Outcome Survey (KOOS), and standardized radiograph, to confirm evidence of medial knee joint osteoarthritis. This information will remain confidential and will not be released by the investigator unless required by law. The treatment of all medical and research data in the study are in accordance with the National Privacy Act. Data Collection: The testing session will require you to attend the Exercise Physiology Laboratories at Murdoch University, on two occasions (week 1 and week 13). These tests will be arranged at a time of convenient to you with each session will take approximately 2 hours. Both sessions will involve the measurements described below. 1. Gait testing to determine muscle activity and knee loading whilst walking. This procedure will require you to walk back and forth along a level walkway, with rest periods between each walking trial. Reflective markers will be placed on your body and your movement will be measured using a motion capture system. Muscle activation patterns of the muscles surrounding the knee will be measured using surface electromyography (EMG) electrodes. These electrodes will be places on the skin over the muscle, which will be shaved and cleaned using abrasive paper and alcohol. This process has the potential to cause some minor skin irritation, however this resolves within 1-2 days. 2. Strength testing of the muscles crossing the knee joint will be undertaken. During these tests, muscle activation patterns will be measured using EMG method as used in the gait test described above. 3. Your knee alignment measured using goniometer device, it will be placed over knee measuring limb alignment in a standing position. 4. Demographic data (weight and height) and self-reported Questionnaires (KOOS and SF-36) will be used to determine your general state of health, functional abilities, level of pain and quality of life. 5. Functional testing will be used to determine functional mobility and strength of the participant. You will be required to complete a 6-minute walk test; walking back and forth along a 30 meter level walkway, 5 sit–to-stands, and finally complete a timed up-and-go test. Rest periods will be given to you after each functional test so not to induce pain or discomfort. 6. Standardized X-ray of your affected knee joint will need to be administered by radiologist at the Radiology Laboratory, Murdoch University. You will be required to wear a physical activity monitor for one week following the first data collection and then again for another week following the second data collection session. This devise is a small unit that is worn on the hip. Strength-Training Program: Between data collection sessions, you will be required to participate in a supervised strength training sessions AND a home based program for one hour, twice a week for a total duration of 12-weeks. The supervised sessions will be held at the Murdoch University Strength and Rehabilitation Laboratory. You will be assigned to one of two lower body strength training programs. Each supervised session will commence with a 5-minute warm-up on a recumbent bike and a short period of stretching on the muscles to be worked in this session. The Page 2 warm-up will be increased as the program progresses and as your ability increases. Exercises will be tailored to your needs; however we need you to perform all of the prescribed exercises at a moderate intensity. The exercises to be used in this study are not expected to exacerbate your condition or cause discomfort. Supervised lab-sessions will use combinations of resistance machines, elastic bands, ankle weights, whilst the home based sessions will use elastic bands for resistance. Both the lab-based sessions and home sessions will concentrate on the same muscle groups. You will be given detailed instructions on how to perform the exercises at home and will also receive instruction sheets outlining how to perform the exercises correctly and stressing any necessary precautions. You will be asked to record your home exercises progress in a journal so that we can monitor progression. Risks As with all exercises there is some risk of injury, however we will ensure that you are using correct technique which will significantly reduce this risk. Following testing you may experience some minor, transient muscle stiffness or mild soreness. Some individuals may experience a minor reaction to the electrodes and markers, but if this does occur it will be temporary. Participants will have to undergo radiation exposure, however risks are very low and participants are not exposed for long periods of time. Benefits For Participants: These procedures are entirely experimental and are not intended to provide any specific medical diagnosis or treatment the participant. By participating in this training study, participants will benefit from provision of free strength training program. Participation in exercise programs prior to surgery has been shown to have positive effects on recovery from surgery in knee osteoarthritis patients. In addition participants will receive a report on effects of strength training on their functional mobility, muscle strength and loading patterns in gait. For Humanity generally: This training study provides great benefits to the medical and general community. However, this research is dependent on the generosity of individuals donating their time. This study will help in the advancement of rehabilitation programs in osteoarthritis suffers that will improve quality of life, prolong time to surgery, and possible prevent disease progression. Voluntary Participation and Withdrawal from the Study It is important that you understand that involvement in this study is voluntary. There will be no consequences if you decide not to participate; we respect you right to decline. If you decide to discontinue your involvement at any time, you may do so Page 3 without providing an explanation. All information you have provided in this study will be destroyed if you withdraw. Your privacy Your privacy is very important to us. Participation in this study and any information will be treated in a confidential manner. Your name and identifying details will not be used in any publication arising out of the research. Following the study the data will be kept in a de-identified format, in a locked cabinet in the office of the Chief Investigator. No information provided will be made public in any form that may identify the participant. De-identified data may be released to other researchers for further analysis at a later date. Questions If you would like to discuss any aspect of this study please feel free to contact Nardine Gillman on 0410327003. We would like to thank you in advance for your assistance with this research project. We look forward to hearing from you soon. Research Team: Miss Nardine Gillman Murdoch University Phone: 0410327003 Email: n.gillman@murdoch.edu.au Dr Alasdair Dempsey Murdoch University Phone 9360 6526 Email: a.dempsey@murdoch.edu.au Dr Mark Hecimovich Murdoch University Phone: 9360 6845 Email: m.hecimovich@murdoch.edu.au The Murdoch University Human Research Ethics Committee has approved this study. If you have any reservation or complaint about the ethical conduct of this research, and wish to talk with an independent person, you may contact Murdoch University’s Research Ethics Office (Tel. 08 9360 6677 or e-mail ethics@murdoch.edu.au). Any issues you raise will be treated in confidence and investigated fully, and you will be informed of the outcome. Page 4