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IRCT20101228005486N8 IRCT 2021-03-17 Iran University of Medical Sciences Therapeutic exercise in knee osteoarthritis Comparison of the short-term effects of clinically supervised and Internet-based exercise therapy on pain, range of motion, and function in patients with knee osteoarthritis: a randomized clinical trial. 2021-05-15 anticipated 60 Complete https://irct.ir/trial/55033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Restricted Randomization method of Block Randomization will be used to ensure that the number of samples allocated to each of the study groups is equal. Random Allocation Software (Latest Version) will also be used as a randomization tool; it is free to use for academic study and can be found at: http://www.msaghaei.com/Softwares/dnld/RA.zip. This software, in addition to simple randomization, will produce random sequences using the blocking method. ‎, Blinding description: In this study, the assessor will be blinded to the study groups. The outcomes will be evaluated pre and post intervention by a sports medicine assistant who will be blind to the presence of patients in the groups. Furthermore, the data obtained from the study will be analyzed by a statistician who is not aware of the patient groups. N/A Primary knee osteoarthritis. Intervention 1: Intervention group: Internet-based Exercise Therapy(IET) group-First, Internet connectivity and instant message systems will be examined for patients in the Internet-based exercise therapy group. In this study, an exercise therapy manual is prepared for the IET group, along with pictures of how to perform the exercise, and it will be given to them the day before the intervention, and they will be asked to follow their exercise therapy protocol similar to the control group and to exercise three times a week for six weeks (a total of 18 sessions). The researcher has used the messenger application to create an Internet group for IET group patients, where they would be able to get information about osteoarthritis of the knee, the procedure of exercise training, and general advice in the form of pictures and animations. This approach allows patients to share their feelings about the disease, symptoms, and exercise treatment, as well as communicate ideas about it. This, of course, would allow patients to continue with their exercise therapy. Furthermore, brief tutorial videos about doing exercise protocols will be prepared and submitted to each patient separately via the messaging application, and if the patient has any questions about doing exercises, she will use the video call choice to learn how to do exercises online or be monitored online and receive sufficient verbal and visual input to execute the correct exercises. Moreover, to ensure the exercise is performed, the researcher calls the patient and a close relative who stays with her on three pre-arranged days and asks questions about how the patient workouts and responds and record them in a logbook that will be prepared for each patient. The exercise protocol for patients with knee osteoarthritis in this study is the same for all participants in both the intervention and control groups, and it includes strengthening exercises to improve thigh muscle strength and stretching exercises to increase the flexibility of the soft tissues around the joint and increase the range of motion. Some exercises have been designed based on the findings of numerous research to enhance the function and coordination of the patients. Intervention 2: Control group: Supervised Exercise Therapy (SET)-Patients in the exercise therapy group will be supervised by a physical medicine assistant at sports medicine clinic for six weeks, alternating three days per week, for a total of 18 sessions under an exercise therapy protocol similar to the IET group. It is worth noting that all exercises will be done in the same protocol for both lower limbs. In the SET group, as in the intervention group, the same questions are asked about how the patient completes exercises and reacts, and this detail is recorded in a logbook that is personalized for each patient. The exercise protocol for patients with knee osteoarthritis in this study is the same for all participants in both the intervention and control groups, and it includes strengthening exercises to improve thigh muscle strength and stretching exercises to increase the flexibility of the soft tissues around the joint and increase the range of motion. Some exercises have been designed based on the findings of numerous research to enhance the function and coordination of the patients. Yes - There is a plan to make this available What will be shared: A portion of the information, such as information on the main outcome or the like, can be shared. When: One year after the publication of articles related to the research project To whom: Researchers and specialists working in universities and health centers Conditions: Analysis on the data delivered after obtaining permission from the researchers Where to obtain: Dr Azar Moezy -Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh St, Sattarkhan Ave, Zip code:14455613131,Tehran. How to obtain: The applicant of the data file should send a request to the researcher via email and the researcher will notify the applicant after negotiating with other research colleagues, and this procedure will take a period of one month. Comments:
public ِDr Bita Zoghalchi
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh St, Sattarkhan .
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 bita.zoghalchi@gmail.com Iran University of Medical Sciences scientific Dr Azar Moezy
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh St, Sattarkhan Ave.
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 moezy.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Primary OA of the knee joint grade 2, 3 according Kellgren and Lawrence scale; ّFemale gender; Age between 50-75; Knee pain for at least six months and with intensity 4 on the VAS scale in activities such as going up and down stairs, sitting and squat; Normal mental state; Ability to walk independently for at least 30 meters BMI equal or less than 30; Patient's consent to participate in the research; Familiarity how to use the Internet and social media for the Internet-based Exercise Therapy (IET) group. 50 years 75 years Female History of knee intra-articular injection in the past six months; History of neuromuscular disease; History of knee traumatic injuries approved by the physician; History of lower limb surgery during the last year; Bone implants, History of new fractures in lower limbs; Malignant tumors; Participating in exercise therapy and physical therapy programs in the recent three months; History of chronic disease or any conditions that known to affect the study; M17 Osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: Internet-based Exercise Therapy(IET) group-First, Internet connectivity and instant message systems will be examined for patients in the Internet-based exercise therapy group. In this study, an exercise therapy manual is prepared for the IET group, along with pictures of how to perform the exercise, and it will be given to them the day before the intervention, and they will be asked to follow their exercise therapy protocol similar to the control group and to exercise three times a week for six weeks (a total of 18 sessions). The researcher has used the messenger application to create an Internet group for IET group patients, where they would be able to get information about osteoarthritis of the knee, the procedure of exercise training, and general advice in the form of pictures and animations. This approach allows patients to share their feelings about the disease, symptoms, and exercise treatment, as well as communicate ideas about it. This, of course, would allow patients to continue with their exercise therapy. Furthermore, brief tutorial videos about doing exercise protocols will be prepared and submitted to each patient separately via the messaging application, and if the patient has any questions about doing exercises, she will use the video call choice to learn how to do exercises online or be monitored online and receive sufficient verbal and visual input to execute the correct exercises. Moreover, to ensure the exercise is performed, the researcher calls the patient and a close relative who stays with her on three pre-arranged days and asks questions about how the patient workouts and responds and record them in a logbook that will be prepared for each patient. The exercise protocol for patients with knee osteoarthritis in this study is the same for all participants in both the intervention and control groups, and it includes strengthening exercises to improve thigh muscle strength and stretching exercises to increase the flexibility of the soft tissues around the joint and increase the range of motion. Some exercises have been designed based on the findings of numerous research to enhance the function and coordination of the patients. Control group: Supervised Exercise Therapy (SET)-Patients in the exercise therapy group will be supervised by a physical medicine assistant at sports medicine clinic for six weeks, alternating three days per week, for a total of 18 sessions under an exercise therapy protocol similar to the IET group. It is worth noting that all exercises will be done in the same protocol for both lower limbs. In the SET group, as in the intervention group, the same questions are asked about how the patient completes exercises and reacts, and this detail is recorded in a logbook that is personalized for each patient. The exercise protocol for patients with knee osteoarthritis in this study is the same for all participants in both the intervention and control groups, and it includes strengthening exercises to improve thigh muscle strength and stretching exercises to increase the flexibility of the soft tissues around the joint and increase the range of motion. Some exercises have been designed based on the findings of numerous research to enhance the function and coordination of the patients. Pain. Timepoint: Pre- and post-intervention. Method of measurement: VAS pain scale. Active knee range of flexion. Timepoint: Pre- and post-intervention. Method of measurement: Goniometery. Thigh girth. Timepoint: Pre- and post-intervention. Method of measurement: With centimeter tape. Functional Tests. Timepoint: Pre- and post-intervention. Method of measurement: Timed Up & Go Test and Six-Minute Walk Test. Vice Chancellor for Research & Technology, Iran University of Medical Sciences Approved 2021-02-08 Ethics Committee of Iran University of Medical Sciences Iran University Of Medical Sciences, Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)