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IRCT20200131046322N1 IRCT 2020-03-09 Mazandaran University of Medical Sciences The effect of exercise on rheumatoid arthritis The effect of 8 weeks of home exercise training on quality of life and quality of disease in patients with rheumatoid arthritis 2019-02-20 anticipated 81 Complete https://irct.ir/trial/45522 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients who were included in the study were randomly divided into three groups of aerobic exercise and strength exercise and control group. Intervention groups received exercise therapy in addition to drug therapy for 8 weeks but control group only received medication for 8 weeks.At the begining and the end of study assessment tools for three groups were evaluated, Randomization description: Patients will be randomly assigned into three study arms using a closed envelope A for control, B for intervention group (1) and C for intervention group (2), Blinding description: Participants were unaware of the allocation of study groups That is, they did not know that there were two groups of exercise therapists in clinical trials but were aware of their group's exercise therapy. N/A Rheumatoid arthritis. Intervention 1: Intervention group: Aerobic exercise (walking) and medication .Aerobic exercise training was recommended for 2 weeks, three to five days a week, 30 to 60 minutes daily, with an intensity of 60 to 80 percent of maximum heart rate. Intervention 2: Intervention group: Strength Exercise Therapy (Weight) and medication .Strength training was taught to patients by dumbbells for 8 week, 2 to 3 days a week, 2 to 3 sets with 8 to 12 repetitions with an intensity 60 to 80% of One-repetition maximum. Intervention 3: Control group: Medication. Yes - There is a plan to make this available What will be shared: All patient data will be published as non-identifiable files for one year after the publication of the article for clinical and academic researchers. When: Applicants will be able to access the data 6 months after the paper printout for one year. To whom: Academic and Clinical Researchers Conditions: Use the document only with the permission of the lead researcher and with the condition of participation in the ongoing research work. Where to obtain: 1-Zahra Madani to Email Adress: z.madani@mazums.ac.ir 2-Afshin Dayer to Email Adress: afshin.dayer@gmail.com How to obtain: The request must first be submitted by email.The person must be fully identifiable with the credentials and indicate the exact reason for the request.After the request is confirmed and the applicant have been identified , the data will be made available to the applicant within one week. Comments:
public Zahra Madani
No 6 , Mostafavian Clinic , 3th Ave , Razi St
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 z.madani@mazums.ac.ir Mazandaran University of Medical Sciences scientific Afshin Dayer
No 6 , Mostafavian Clinic , 3th Ave , Razi St
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 afshin.dayer@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) The patient was diagnosed with rheumatoid arthritis based on the diagnostic criteria and get rheumatologist approval. Patient age between 30 and 60 years The duration of illness is less than 10 years from diagnosis. The patient has no deformity. Do not be in active phase of inflammation while performing patient plan. The severity of the disease was less than 3.2 based on criteria DAS28, It means the severity of the disease is mild or in remission. The patient should take a lower dose of 15 mg corticosteroid. The patient is not a high risk cardiovascular risk factor.(Severe diabetes, severe hypertension, severe cardiovascular disease) Do not experience trauma or fracture or soft tissue damage during design. Do not suffer from problems such as psychosis or severe depression for psychological issues. 30 years 60 years Both The patient is not satisfied with the plan or has no reason to continue cooperating while performing the plan. Unable to cooperate in field exercise test (6 minutes walk) and One-repetition maximum test. M05.9 Rheumatoid arthritis with rheumatoid factor, unspecified Treatment - Other Treatment - Other Treatment - Drugs Intervention group: Aerobic exercise (walking) and medication .Aerobic exercise training was recommended for 2 weeks, three to five days a week, 30 to 60 minutes daily, with an intensity of 60 to 80 percent of maximum heart rate. Intervention group: Strength Exercise Therapy (Weight) and medication .Strength training was taught to patients by dumbbells for 8 week, 2 to 3 days a week, 2 to 3 sets with 8 to 12 repetitions with an intensity 60 to 80% of One-repetition maximum. Control group: Medication Severity score of rheumatoid arthritis using Disease Activity Score (DAS)28 questionnaire. Timepoint: Before and after intervention. Method of measurement: Disease Activity Score (DAS)28 questionnaire. Determining the quality of life of patients using WHOQOL-BREF short questionnaire. Timepoint: Before and after intervention. Method of measurement: WHOQOL-BREF short questionnaire. Chest press One-repetition maximum test. Timepoint: Before and after the intervention of strength exercise. Method of measurement: Machine chest press. Leg press one-repetition maximum test. Timepoint: Before and after the intervention of strength exercise. Method of measurement: Machine leg press. Mazandaran University of Medical Sciences Approved 2019-01-26 Organizational Ethics Committee of Imam Hospital of Mazandaran University of Medical Sciences Amir Mazandarani Ave, Imam Khomeini Hospital Sari Mazandaran Iran (Islamic Republic of)