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IRCT20180506039542N1 IRCT 2018-06-29 Tehran University of Medical Sciences Effects of exercise in major depression disorders Can exercise enhance the positive effects of sertraline in patients with major depressive disorders? A randomized clinical trial 2015-04-04 anticipated 30 Complete https://irct.ir/trial/30959 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were randomly assigned to either control or study group with a 1:1 allocation ratio by TENALEA, which is an online, central randomization service using permuted blocks of random sizes. In order to confirm allocation concealment, the randomization code was not released by the service until the patient had been enrolled in the study, which happened after all baseline measurements have been completed, Blinding description: Since exercise is an overt behavior, there was not the possibility of blinding the participants and care providers. Thus, only those assessing outcomes were blinded. N/A Major depressive disorder. Intervention 1: Control group: The control group were patients diagnosed with major depression on sertraline prior to this study with a dosage range of 50 to 150 mg daily. They continued to receive sertraline for 8 weeks (during the study). Intervention 2: Intervention group: Patients assigned to the test group were asked to perform regular exercises, 60 minutes a session, three times a week, under the supervision of a registered trainer for a total duration of 8 weeks. Physical activity was scheduled as aerobic, stretching and strengthening exercises. Patients were asked to do 15 minutes of warm up, and 40 minutes of stretching and strengthening exercises followed by 5 minutes of cooling down with low intensity activities. Patients enrolled in the test group received sertraline prior to this study with a dosage range of 50 to 150 mg daily which continued during the study. 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 more information
public Bita Tavana
No.7, Jalal-e-Al-e-Ahmad Highway. Sports and Exercise Research Center, the Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 14395-578 +98 21 8863 0227 b-tavana@farabi.tums.ac.ir Tehran University of Medical Sciences scientific Bita Tavana
No.7, Jalal-e-Al-e-Ahmad Highway. Sports and Exercise Research Center, the Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 14395-578 +98 21 8863 0227 b-tavana@farabi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients were diagnosed with major depression based on DSM-V criteria All the patients were on sertraline prior to study Patients were healthy and were able to execute regular exercise 18 years 65 years Both Patients who had psychosis Patients who had suicidal actions or thoughts Patients who had self-mutilation Patients who had chronic diseases associated with vital organs such as heart, lungs, and kidneys Patients who had bone and soft tissue disorders which made it impossible to comply with the exercise schedule V Mental and behavioral disorders Treatment - Drugs Behavior Control group: The control group were patients diagnosed with major depression on sertraline prior to this study with a dosage range of 50 to 150 mg daily. They continued to receive sertraline for 8 weeks (during the study). Intervention group: Patients assigned to the test group were asked to perform regular exercises, 60 minutes a session, three times a week, under the supervision of a registered trainer for a total duration of 8 weeks. Physical activity was scheduled as aerobic, stretching and strengthening exercises. Patients were asked to do 15 minutes of warm up, and 40 minutes of stretching and strengthening exercises followed by 5 minutes of cooling down with low intensity activities. Patients enrolled in the test group received sertraline prior to this study with a dosage range of 50 to 150 mg daily which continued during the study. Depression score in Hamilton depression scale. Timepoint: At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise. Method of measurement: Hamilton depression scale. Depression scores in Beck depression inventory. Timepoint: At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise. Method of measurement: Beck depression inventory. Anxiety scores in Hamilton anxiety scale. Timepoint: At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise. Method of measurement: Hamilton anxiety scale. Anxiety scores in Beck anxiety inventory. Timepoint: At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise. Method of measurement: Beck anxiety inventory. Sleep quality index in Pittsburg sleep quality index. Timepoint: At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise. Method of measurement: Pittsburg sleep quality index. Body mass index. Timepoint: At the beginning of the study (prior to initiation of the intervention) and eight weeks after starting of the exercise. Method of measurement: The body weight (kilograms) divided by the square of the body height (square meters). Tehran University of Medical Sciences Approved 2015-05-03 Ethics committee of Tehran University of Medical Sciences Vice Chancellor for Research and Technology, 6th floor, Central Building of Tehran Universtiy of Medical Sciences, Corner of Qods Street, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)