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IRCT20201030049193N4 IRCT 2022-06-29 Kharazmi University Comparison of the effect of home exercise with and without weight loss program in people with chronic low back pain Comparison of the effect of home exercise with and without weight loss program on pain, disability, fear of movement, and endurance of trunk muscles in people with non-specific chronic low back pain 2021-12-09 anticipated 60 Complete https://irct.ir/trial/60866 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: An uninvolved person in the study helped us via random number allocation software to randomly assign a number to each of the participants (60 participants for both the groups training at home n=30 and weight loss training n=30). Then after recording the pretest session measurements, the assigning group (assigned via SNOSE method) was considered for each of the participants, Blinding description: In order for single blinding, some general information about how to perform the training and testing methods will be given to all the participants. However no information will be provided to the participants on which training group they will be placed in. N/A non-specific chronic low back pain. Intervention 1: First intervention group: Practice at home: Exercises in this intervention included controlling the abdominal muscles and strengthening the thigh muscles. The exercises consisted of 5 movements for 6 weeks, 3 sessions per week, 3 sets per day, and each set of 10 repetitions for the subjects. Each session lasted 60 minutes, with the initial and final 10 minutes including warm-up and cooling, respectively. Progress in exercise was determined based on the pain intensity of each subject. Intervention 2: The second intervention group: Weight lose: In addition to receiving the exercise therapy protocol, the subjects in this group also received a weight loss program for 6 weeks, 3 sessions per week. If the subject had a treadmill, he could use it after complete training on how to work with the treadmill. Each training session consisted of a 40-minute walk, which included 5 minutes of basic warm-up, 30 minutes of walking at a speed of your choice, progressing at a faster pace, and finally 5 minutes slower to cool down. 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 Mina Afshari
Kharazmi Faculty of Physical Education and Sports Sciences, at the end of Hesari Street, Mirdamad Boulevard
Tehran Iran (Islamic Republic of) 15875-4398 +98 21 2222 8001 minaafshar.ma8@gmail.com Kharazmi University scientific Amir Letafatkar
Kharazmi Faculty of Physical Education and Sports Sciences, at the end of Hesari Street, Mirdamad Boulevard
Tehran Iran (Islamic Republic of) 15875-4398 +98 21 2222 8001 letafatkaramir@yahoo.com Kharazmi University Iran (Islamic Republic of) Male and female patients with nonspecific chronic low back pain Age range between 20 to 60 years Low back pain for more than 3 months 20 years 60 years Both People who had intervertebral disc surgery. People whose back pain is caused by something else, such as a fracture, a cancerous tumor, a severe lumbar slip, and an infection. People with underlying mental illness People with suspected or corona virus People who are not able to walk and sit alone and control urination and defecation. People with uncontrolled heart disease. The need for spinal and disc herniation surgery Spine pathology Use any type of medication or pain reliever and treatment to relieve back pain M95.5 Acquired deformity of pelvis Treatment - Other Treatment - Other First intervention group: Practice at home: Exercises in this intervention included controlling the abdominal muscles and strengthening the thigh muscles. The exercises consisted of 5 movements for 6 weeks, 3 sessions per week, 3 sets per day, and each set of 10 repetitions for the subjects. Each session lasted 60 minutes, with the initial and final 10 minutes including warm-up and cooling, respectively. Progress in exercise was determined based on the pain intensity of each subject. The second intervention group: Weight lose: In addition to receiving the exercise therapy protocol, the subjects in this group also received a weight loss program for 6 weeks, 3 sessions per week. If the subject had a treadmill, he could use it after complete training on how to work with the treadmill. Each training session consisted of a 40-minute walk, which included 5 minutes of basic warm-up, 30 minutes of walking at a speed of your choice, progressing at a faster pace, and finally 5 minutes slower to cool down. Pain. Timepoint: Pre-test (before the start of the study) and post-test (at the end of the study). Method of measurement: The pain variable was measured by a visual pain intensity scale. Disability. Timepoint: Pre-test (before the start of the study) and post-test (at the end of the study). Method of measurement: The Oswestry questionnaire was used to assess functional impairment in daily activities. Fear of movement. Timepoint: Pre-test (before the start of the study) and post-test (at the end of the study). Method of measurement: The fear of movement variable was examined according to the Tampa movement fear questionnaire. Endurance of trunk muscles. Timepoint: Pre-test (before the start of the study) and post-test (at the end of the study). Method of measurement: Trunk muscles endurance was performed in two modes of flexion and extension. Kharazmi University Approved 2021-10-20 Research ethic committees of sport sciences research institute (SSRI) No. 24, Unit 2, Mehrnami St., Tehranpars First Square Tehran Tehran Iran (Islamic Republic of)