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IRCT20220917055973N1 IRCT 2022-10-02 Tehran University of Medical Sciences Developing an 8-week, tele-education weight control and exercise program, and evaluating its effects on weight and pain reduction in patients with obesity and knee osteoarthritis Developing an 8-week, tele-education weight control and exercise program, and evaluating its effects on weight and pain reduction in patients with obesity and knee osteoarthritis referred to Imam Khomeini Hospital: A ِdouble-blinded randomized clinical trial. 2022-10-23 anticipated 30 Complete https://irct.ir/trial/65943 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, block randomization is used. Thirty participants in this research will be placed in 3 blocks of ten that will be randomly selected by someone other than the researcher. Assigning each of the letters A and B to each of the intervention and control groups is done by a person other than the researcher (a third person), Blinding description: This study is double-blinded. Each candidate is blinded to their group (Intervention or control). The assessor of outcomes, including height, weight, waist circumference, hip circumference, and functional tests is blinded. N/A knee osteoarthritis. Intervention 1: Intervention group: participating in online training classes includes nutrition, physical activity, and cognitive behavioural therapy (CBT). Also, the knee exercise program including stretch and strength exercises is sent to them based on a weekly schedule for eight weeks. Intervention 2: Control group: one session of educational recommendations on weight loss and aerobic exercise, in addition to the knee exercises for eight weeks. Yes - There is a plan to make this available What will be shared: Initial results and other items at the request of researchers. When: The period of access starts 6 months after the publication of results. To whom: Please contact this email: z_alizadeh@tums.ac.ir Conditions: Please contact this email: z_alizadeh@tums.ac.ir Where to obtain: Please contact this email: z_alizadeh@tums.ac.ir How to obtain: Please contact this email: z_alizadeh@tums.ac.ir Comments:
public Reyhaneh Khazaei
Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2282 reyhanehkh@yahoo.com Tehran University of Medical Sciences scientific Zahra Alizadeh
Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1637 z_alizadeh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 45 and 75 years Female or male Radiographic diagnosis of knee osteoarthritis Ability to use the online application No history of bariatric surgery, uncontrolled diabetes, uncontrolled blood pressure, uncontrolled cardiovascular diseases, severe musculoskeletal and neurological disease and any other disease that can limit daily routine activities. 45 years 75 years Both Getting pregnant Presence of a metal device or heart pacemaker in the body Recent diet therapy with weight loss (5% over 3 months or 10% over 6 months) End-stage osteoarthritis based on the Kellgren and Lawrence classification Use of weight loss medications such as appetite suppressants or any medication that has a significant effect on weight such as steroids. Recent intra-articular injections within the last 6 months Use of physiotherapy devices M17 Osteoarthritis of knee Lifestyle Lifestyle Intervention group: participating in online training classes includes nutrition, physical activity, and cognitive behavioural therapy (CBT). Also, the knee exercise program including stretch and strength exercises is sent to them based on a weekly schedule for eight weeks. Control group: one session of educational recommendations on weight loss and aerobic exercise, in addition to the knee exercises for eight weeks. Visual Analogue Scale score. Timepoint: Before the intervention, after eighth weeks. Method of measurement: Using a pain ruler with a scale of 0 to 100. Knee Injury and Osteoarthritis Outcome Score. Timepoint: Before the intervention, after eighth weeks. Method of measurement: KOOS questionnaire. EuroQol five-dimension scale questionnaire. Timepoint: Before the intervention, after eighth weeks. Method of measurement: EQ5D questionnaire. Timed up and go. Timepoint: Before the intervention, after eighth weeks. Method of measurement: Second. 30-second Chair Stand. Timepoint: Before the intervention, after eighth weeks. Method of measurement: Counting. Body composition analysis. Timepoint: Before the intervention, after eighth weeks. Method of measurement: Body composition analysis. Waist circumference. Timepoint: Before the intervention, after eighth weeks. Method of measurement: Meter. Hip circumference. Timepoint: Before the intervention, after eighth weeks. Method of measurement: Meter. Weight. Timepoint: Before intervention, week 1, week 2, week 3, week 4, week 5, week 6, week 7, end of week 8. Method of measurement: Weighting scale. Global physical activity questionnaire. Timepoint: Before the intervention, after eighth weeks. Method of measurement: G-PAQ questionnaire. Use of painkillers. Timepoint: Before the intervention, after eighth weeks. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2022-05-21 Imam Khomeini Hospital Complex - Tehran University of Medical Sciences (Research Ethics Committee) Deputy of Research and Technology, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)