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IRCT20221202056687N1 IRCT 2022-12-15 Tehran University of Medical Sciences "Effect of Pulsed Electromagnetic Field and Exercise Therapy in treatment of Osteoporosis" PEMF Effects of Application of Pulsed Electromagnetic Field and Therapeutic Exercise on Bone Mineral Density and Metabolism, and Quality of Life in Postmenopausal Osteoporotic Women 2023-01-20 anticipated 36 Complete https://irct.ir/trial/67169 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign patients, sealed envelopes containing the words "pulsed electromagnetic field" or "therapeutic exercise" or "combination of pulsed electromagnetic field + therapeutic exercise" will be prepared. After flipping the cards, the clinic secretary clinic will randomly select one of the envelopes for each patient. The use of this method guarantees randomization, Blinding description: This study is single-blinded study, which means that an experience physiotherapist do the intervention and another physiotherapist will do the evaluations. As a result, the evaluator will not know which group the patient belongs to. N/A Osteoporosis. Intervention 1: Intervention group: Pulse Electro Magnetic field. Intervention 2: Intervention group: Exercise therapy. Intervention 3: Intervention group: Pulsed Electromagnetic field+Exercise therapy. Yes - There is a plan to make this available What will be shared: If needed by the researchers and their request, the raw data of the research and Its analysis will be provided to researchers When: After the publication of the articles resulting from the research To whom: Researchers working in academic institutions Conditions: The data is only available to other researchers to study and review treatment results Placed Where to obtain: By sending an email to the corresponding author How to obtain: Send an email to the responsible author and request the document Comments:
public Azadeh Shadmehr
Enghelab St., Faculty of Rehabilitation Sciences, Department of Physiotherapy
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 shadmehr@tums.ac.ir Tehran University of Medical Sciences scientific Fatemeh Sangtarash
Enghelbal St., Faculty of Rehabilitation Sciences, Department of Physiotherapy
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5 f-sangtarash@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) women at the age of 55-68, having reached menopause at least 5 year before the study. A body mass index of 22-30 T-score for the hip or lumbar spine -2.5 SD or less. do not have a history of overioectomy syrgery Do not have a history of osteoporosis fracture 55 years 68 years Female Participating in sports regularly for at least one year before starting the study (regular exercise means at least 30 minutes a day and 3 days a week) Taking drugs that affect bone metabolism, except for daily calcium and vitamin D and weekly alendronite tablets, which will be prescribed by the rheumatology consultant of the study with the same dose for all participants. The presence of any medical problem affecting the person's movement (diabetes - diseases of the vestibular system - uncorrected vision or hearing disorders - neurological diseases A history of surgery in the spine and pelvis and the use of tools to fix it or a history of surgery in the lower limbs • History of hormone therapy in the last 6 months A history of having cardiovascular diseases, such as uncontrolled blood pressure, which will be considered as an exclusion criterion for groups that will do exercise therapy Using physiotherapy modalities effective on bone metabolism, such as using WBV, LPL, PEMF modalities in the last 6 month Using tranquilizers (Tranquillizer) in both minor classifications (anti-anxiety, diazepam, oxazepam, alprazolam, etc.) and major (antipsychotic drugs such as haloperidol, phenotazines, fluphenazine, etc.) in three last month Unwillingness of the samples to continue the treatment and not participating regularly in the treatment program A change in sample conditions that would result in missing one of the inclusion criteria M81.0 Age-related osteoporosis without current pathological fracture Rehabilitation Rehabilitation Rehabilitation Intervention group: Pulse Electro Magnetic field Intervention group: Exercise therapy Intervention group: Pulsed Electromagnetic field+Exercise therapy Bone mineral Density. Timepoint: At the beginning of the intervention and 12 weeks after the end of the intervention. Method of measurement: The use of X-Ray absorption method with dual energy DXA will be measured using the HOLOGENIC QDR1000 devic. Bone Turnover markers-bone specific alkalin phosphatase(BSALP). Timepoint: Before the start of the intervention - immediately after the end of the intervention - after a 12-week follow-up from the end of the intervention. Method of measurement: Blood test and examination of blood sample with the laboratory method of ELISA. Bone Turnover markers-N- terminal telopeptide of type 1 collagen. Timepoint: Before the start of the intervention - immediately after the end of the intervention - after a 12-week follow-up from the end of the intervention. Method of measurement: Blood test and examination of blood sample with the laboratory method of ELISA. Quality of life. Timepoint: Before the start of the intervention - immediately after the end of the intervention - after a 12-week follow-up from the end of the intervention. Method of measurement: Quality Of Life Questionnaire Of European Foundation for Osteoporosis. Thoracic kyphosis. Timepoint: before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention. Method of measurement: Photogrammetry method. Lumbar lordosis. Timepoint: before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention. Method of measurement: Photogrammetry method. Functional Balance. Timepoint: before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention. Method of measurement: Functional balance study with Timed Up and Go (TUG), Unilateral Stance Test(USL). Muscle Strenght. Timepoint: before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention. Method of measurement: Using micro manual muscle tester. Fear of falling. Timepoint: before and after the intervention (12 weeks later) ,and 12 weeks follow up after the end of the intervention. Method of measurement: persian version of Falls Efficacy Scale-International Questionnaire. Tehran University of Medical Sciences Approved 2022-12-11 Ethics committee of Tehran University of Medical Sciences Faculty of Rehabilitation Sciences, Enghelab St., Tehran Tehran Tehran Iran (Islamic Republic of)