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IRCT20191221045846N2 IRCT 2020-06-28 Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology Short term effects of exercises among knee osteoarthritis (OA) participants who are overweight or obese. Short term effects of strengthening exercises of lower limb rehabilitation protocol (LLRP) on pain, stiffness, physical function and body mass index (BMI) among knee osteoarthritis (OA) participants who are overweight or obese. 2020-07-10 anticipated 50 Complete https://irct.ir/trial/49143 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher will allocate the selected knee osteoarthritis participants into two groups, namely, Rehabilitation Protocol Group (RPG) and Control Group (CG) by simple random technique using a computer-generated random number. The participants in the RPG will follow the strengthening exercise of LLRP and IDC for duration of 4-weeks. The participants in the CG will not involved in the rehabilitation protocols, but these participants will follow only the IDC for the duration of 4-weeks at their houses, Blinding description: The principle investigator will not be blinded. The participants receiving the intervention will be blinded by simply not informing them of their treatment allocation. The coordinators collecting data will be independent individuals from trials and will be unaware of the group allocation. There will be different coordinators at the initial and final evaluation. Individuals performing the statistical analysis will be blinded by labelling the groups with non-identifying terms (such as X and Y). 2 Osteoarthritis of knee. Intervention 1: The participants in this group (Rehabilitation Protocol Group) will perform the strengthening exercises of lower limb rehabilitation protocol (LLRP) and follow the instructions of daily care (IDC) for duration of four weeks at their houses according to the provided leaflet. Each training session of strengthening exercises will be performed three times a week for four weeks at their houses. These training sessions were the strengthening exercises of lower limbs in non-weight bearing sitting and lying positions. Each training session will consist of 45–60 minutes of training followed by 10 minutes warm up at the start and 10 minutes cool down at the end of training protocol. Intervention 2: The participants in this group (Control Group) will follow only the instructions of daily care (IDC) for duration of four weeks at their houses according to the provided leaflet. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Muhammad Tariq Rafiq
54000 B. Rehmatul-Lil-Alamine Post Graduate Institute of Cardiology, Punjab Employees Social Security Institution, Multan Chongi, Multan Road Lahore
Lahore Pakistan 54000 +92 42 99330101 drtariqrafiq149@yahoo.com Punjab Employees Social Security Institution scientific Mohamad Shariff A Hamid
Sports Medicine Department, University of Malaya Medical Centre, Kuala Lumpur, Malaysia
Kuala Lumpur Malaysia 59100 +60 3-7967 6669 ayip@um.edu.my University of Malaya Pakistan Overweight or obese knee OA participants aged between 45 to 60 years. Familiar with WhatsApp application Participants will be chosen from the urban area community of Punjab Lahore, Pakistan. The sample included males and females having OA of one or both knees confirmed by medical specialist according to the Kellgren and Lawrence radiographic scale for the assessment of OA 45 years 60 years Both Rheumatoid arthritis System lupus erythematosus Flat feet Spinal deformities Unable to walk independently History of metabolic, hormonal, orthopaedic or cardiovascular disease Previous surgery of knee/s Injections of knee/s for the last six months. M17 Osteoarthritis of knee Treatment - Other Treatment - Other The participants in this group (Rehabilitation Protocol Group) will perform the strengthening exercises of lower limb rehabilitation protocol (LLRP) and follow the instructions of daily care (IDC) for duration of four weeks at their houses according to the provided leaflet. Each training session of strengthening exercises will be performed three times a week for four weeks at their houses. These training sessions were the strengthening exercises of lower limbs in non-weight bearing sitting and lying positions. Each training session will consist of 45–60 minutes of training followed by 10 minutes warm up at the start and 10 minutes cool down at the end of training protocol. The participants in this group (Control Group) will follow only the instructions of daily care (IDC) for duration of four weeks at their houses according to the provided leaflet. Knee pain. Timepoint: at baseline and after 4 weeks of intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Stiffness. Timepoint: At baseline and after 4 weeks of intervention. Method of measurement: WOMAC score. Physical function. Timepoint: At baseline and after 4 weeks of intervention. Method of measurement: WOMAC score. Body Mass Index. Timepoint: At baseline and after 4 weeks of intervention. Method of measurement: Calculated by the formula Weight (kg)/Height(meter square). Patients satisfaction. Timepoint: After 4 weeks of intervention. Method of measurement: Numeric rating scale ranging from 0 to 10. Exercise adherence. Timepoint: After 4 weeks of intervention. Method of measurement: Numeric rating scale ranging from 0 to 10. University of Malaya Rehmatul-Lil-Alameene Post Graduate Institute of Cardiology N/A Approved 2020-05-20 Ethical Committee RAIC PESSI (Rehmatul-Lil-Alameen Postgraduate Institute of Cardiology, Punjab Empl Multan Chongi Multan Road Lahore, Lahore Punjab Pakistan