]>
IRCT20240619062183N1 IRCT 2024-10-05 Shahid Beheshti University of Medical Sciences The Effect of Home Hand Exercise in patients with Rheumatoid Arthritis The Effect of Home Hand Exercise on joint pain and range of motion in patients with Rheumatoid Arthritis: A Randomized Clinical Trial 2024-10-11 anticipated 154 Complete https://irct.ir/trial/77519 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: All people eligible to enter the study will be randomly placed in one of the two intervention or control groups with a ratio of 1:1. The randomization method will be permuted block randomization, the blocks will be based on the sample size in 25 blocks in sizes 2, 4, 6, 8, 10 using the "Ralloc" package in STATA software. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual). 3 Rheumatoid Arthritis. Intervention 1: Intervention group: under standard medical treatment and performing sports exercises according to specialized training by a sports medicine specialist in the hand three times a day (3 sets of 10 for range of motion and pain and one set of 10 for hand grip twice a day) in home for a maximum of one month. Intervention 2: Control group: they are only subjected to standard drug treatment without doing sports (follow-up period = one month from the start of the study). Yes - There is a plan to make this available What will be shared: All patient information will be entered into the database (Excel file) after collecting it in a paper checklist, and after checking the range of data in terms of the presence of outliers and cleaning it (data cleaning), it will be prepared for statistical analysis. The final data file will be provided to the research assistant of internal diseases department to conduct further studies. When: The access period starts 6 months after the results are published To whom: Researchers working in academic institutions Conditions: If there is a positive conclusion from the plan and the need for further studies in this field Where to obtain: Dr. Niloofar Abozarzadeh, Tehamtan - Imam Hossein Hospital - Rheumatology Clinic How to obtain: Through the written request of the applicant to the research department of the hospital Comments:
public Niloofar Abozarzadeh Tahamtan
Shahid Madani St, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 niloofar.abozarzadeh@gmail.com Shahid Beheshti University of Medical Sciences scientific Parisa Delkash
Shahid Madani St, Tehran, Iran
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 3000 parisa.delkash@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years of age with rheumatoid arthritis, in whom the diagnosis of rheumatoid arthritis is definite based on the criteria of ACR/EULAR 2010 The absence of joint pain in the wrist, metacarpopharngeal or proximal inter-phalanx History of stable medication in the last 3 months Personal expression is the inability to perform daily activities 18 years no limit Both Patients with diabetes and Body Mass Index above 30 kg/m2 (BMI ≥ 30 k/m2), Patients who have significant Osteoarthritis in the hands, Hand surgery in the last 6 months Patients who have active disease (in phase are acute) M05 Rheumatoid arthritis with rheumatoid factor Rehabilitation N/A Intervention group: under standard medical treatment and performing sports exercises according to specialized training by a sports medicine specialist in the hand three times a day (3 sets of 10 for range of motion and pain and one set of 10 for hand grip twice a day) in home for a maximum of one month Control group: they are only subjected to standard drug treatment without doing sports (follow-up period = one month from the start of the study). Examining the pain level is a scale to measure the intensity of the patient's pain at rest, which is numbered from zero to ten. The number zero indicates the absence of pain and the number ten indicates the maximum amount of pain in the state of rest. Timepoint: The duration of the study is one month, and all the mentioned outcomes are measured twice, once at zero time (start of the study and before the intervention) and the second time on the 30th day after the intervention. Method of measurement: Visual pain measurement system (VAS) will be used to measure the pain level of the subjects. This method is a scale to measure the patient's pain intensity at rest, which is numbered from zero to ten. The number zero indicates the absence of pain and the number ten indicates the maximum amount of pain in the state of rest. Range of motion. Timepoint: The duration of the study is one month, and all the mentioned outcomes are measured twice, once at zero time (the beginning of the study and before the intervention) and the second time on the 30th day after the intervention. Method of measurement: The patient's range of motion in hand flexion and extension is measured by goniometer. Hand grip. Timepoint: The duration of the study is one month, and all the mentioned outcomes are measured twice, once at zero time (the beginning of the study and before the intervention) and the second time on the 30th day after the intervention. Method of measurement: Hand Grip is measured by dynamometer. Shahid Beheshti University of Medical Sciences Approved 2024-04-09 Ethics Committee of School of Medicine, Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Valenjak, Tehran Tehran Tehran Iran (Islamic Republic of)