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IRCT20220206053950N2 IRCT 2022-09-07 Zanjan University of Medical Sciences Effectiveness of muscle strengthening exercises on knee osteoarthritis Effectiveness of muscle strengthening exercises on pain, physical function and morning stiffness of patients with osteoarthritis of knee : a randomized four-arm controlled trial 2016-02-25 anticipated 96 Complete https://irct.ir/trial/65073 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The participants were asked to regularly perform exercises 5 days a week, for 8 weeks (3 sets/day, 10-15 repetitions). To ensure regular exercising according to the instructions, the participants were provided with written instructions of the exercise programs and a specific form to record their daily exercises during 8 weeks, in addition, they were telephoned once a week by the physiotherapist, encouraging patients to properly adhere to the interventions, Randomization description: Random sequence was made by Microsoft Excel using the RAND() function of this software. A 1:1:1:1 allocation was made by an independent investigator using Blocked randomization with randomly varying blocks of 4 and 8 and stratified randomization considering Kellgren-Lawrence grade 1-2 or 3. The allocation sequence was concealed from the investigator enrolling and assessing participants in sequentially numbered, opaque, sealed envelopes, Blinding description: The present study is single-blind. The principal investigator, outcome assessor, and data collector are blinded by not informing them of the group allocation. Data analyst is kept masked by providing a blinded version of data. The care provider and the participants are not blinded. Considering the nature of the intervention, which is an exercise therapy, and the fact that the control group does not receive any intervention, naturally, it is not possible to blind the participants and care providers during the trial. N/A Osteoarthritis of knee. Intervention 1: Intervention group: received home-based quadriceps strengthening exercises, regularly perform 3 sets of exercises per day, 10-15 repetitions, 5 days a week for 8 weeks. Intervention 2: Intervention group: received home-based hamstring strengthening exercises, regularly perform 3 sets of exercises per day, 10-15 repetitions, 5 days a week for 8 weeks. Intervention 3: Intervention group: received home-based strengthening both quadriceps and hamstring muscles groups, regularly perform 3 sets of exercises per day, 10-15 repetitions, 5 days a week for 8 weeks. Intervention 4: Control group: did not receive the intervention during this period. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Mina Rostami
No. 4511, Helal 1Alley, Avesta Ave., Phase 3, Golshahr Town
Zanjan Iran (Islamic Republic of) 4514151659 +98 991 207 7996 mina.rostami1373@gmail.com Zanjan University of Medical Sciences scientific Mina Rostami
No. 4511, Helal 1 Ave, Golshahr, Zanjan.
Zanjan Iran (Islamic Republic of) 4514151659 +98 991 207 7996 mina.rostami1373@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients with knee osteoarthritis (grades I-III in the Kellgren-Lawrence score) Patients aged 40-70 years Patients who had pain, morning stiffness of shorter than 30 minutes, or knee crepitus. 40 years 70 years Both Concomitant involvement with musculoskeletal diseases other than knee osteoarthritis in one or both knees within the last 6 months A history of knee joint surgery Intra-articular injection of corticosteroids or hyaluronic acid in the knee joints within the past 30 days Non-steroidal anti-inflammatory drugs (NSAIDs) or glucosamine intake within the last 30 days Participation in the muscle-strengthening programs for the knee joint within the last 6 months M17 Osteoarthritis of knee Rehabilitation Rehabilitation Rehabilitation N/A Intervention group: received home-based quadriceps strengthening exercises, regularly perform 3 sets of exercises per day, 10-15 repetitions, 5 days a week for 8 weeks. Intervention group: received home-based hamstring strengthening exercises, regularly perform 3 sets of exercises per day, 10-15 repetitions, 5 days a week for 8 weeks. Intervention group: received home-based strengthening both quadriceps and hamstring muscles groups, regularly perform 3 sets of exercises per day, 10-15 repetitions, 5 days a week for 8 weeks. Control group: did not receive the intervention during this period. Score of knee pain on Visual Analogue Scale (VAS) score. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the initiation of the exercise therapy. Method of measurement: Visual Analogue Scale (VAS). Score of knee physical function on the Western Ontario and McMaster (WOMAC) Index. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the initiation of the exercise therapy. Method of measurement: Western Ontario and McMaster (WOMAC) Index. Score of knee morning stiffness on the Western Ontario and McMaster (WOMAC) Index. Timepoint: At the beginning of the study (before the intervention) and 8 weeks after the initiation of the exercise therapy. Method of measurement: Western Ontario and McMaster (WOMAC) Index. Zanjan University of Medical Sciences Approved 2016-02-18 Ethics committee of Zanjan University of Medical Sciences Room No. 22, First Floor, Ethics Committee in Biomedical, Vice-Chancellor for Research and Technology, Azadi Blvd., Zanjan Zanjan Zanjan Iran (Islamic Republic of)