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IRCT20100623004251N13 IRCT 2020-04-04 Iran University of Medical Sciences Comparison of the Effect of Types of Orthosis and Back School Program on Physical Fitness and Respiratory Capacity of Elderly with Thoracic Kyphosis Comparison of the Effect of Types of Orthosis and Back School Program on Physical Fitness and Respiratory Capacity of Elderly with Thoracic Kyphosis 2019-10-23 anticipated 60 Complete https://irct.ir/trial/42393 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Thoracic region postural Kyphosis. Intervention 1: Intervention group 1: Spinomed Orthosis plus Back School Program Exercise Therapy: The spinomode orthosis is made of a dorsal, pelvic belt and ventricle.The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. This orthosis is adjustable and can be used for different sizes. The latest version of Spinomed Orthosis is available in various sizes from the German Medi Company. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic). It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month. Intervention 2: Intervention group 2: Elderly Orthosis plus Back School Program Exercise Therapy Spinal Elderly Orthosis: This orthosis is made of a dorsal, pelvic belt and ventricle. The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. The latest version of Spinal Elderly Orthosis is produced by the Iranian company Savad Teb. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic) . It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic) , which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month. Intervention 3: Control group: Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed.The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month. Yes - There is a plan to make this available What will be shared: Changes in physical fitness after the intervention in the three study groups and compared to each other Changes in muscle strenght after the intervention in the three study groups and compared to each other Changes in endurance performance after the intervention in the three study groups and compared to each other Changes in balance status after the intervention in the three study groups and compared to each other Changes in respiratory capacity after the intervention in the three study groups and compared to each other When: Start of access to data 6 months after publishing the article To whom: Researchers working in academic institutions that want to use these findings in systematic reviews and meta analysis. Conditions: Due to the presence of authors at accademic center, it's nessecary to obtain college written permission for sending data. Therefore, data will be sent no later than 6 months after requesting college written permission. Where to obtain: Rasoul Akram Hospital , department of Sports Medicine Dr Haleh dadgostar, Dr Samaneh ataie How to obtain: Information about who will review requests and criteria for reviewing requests may also be provided. Comments:
public Haleh Dadgostar
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 7308 dadgostar.h@iums.ac.ir Iran University of Medical Sciences scientific Haleh Dadgostar
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1445613131 098 21 66537308 dadgostar.h@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age 60 years or older Kyphosis angle 50 degrees or more Ability to sit and stand up and walk at least 10 meters independently 60 years no limit Both Physical abnormalities other than kyphosis which may need treatment prior to research or impair the research process People who had a history of fracture or surgery in the lower extremity or spine 12 months before the begining of the research Any illness or disorder that disables one's participation in exercises and group activities M40.04 Postural kyphosis, thoracic region Treatment - Devices Treatment - Devices Treatment - Other Intervention group 1: Spinomed Orthosis plus Back School Program Exercise Therapy: The spinomode orthosis is made of a dorsal, pelvic belt and ventricle.The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. This orthosis is adjustable and can be used for different sizes. The latest version of Spinomed Orthosis is available in various sizes from the German Medi Company. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic). It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month. Intervention group 2: Elderly Orthosis plus Back School Program Exercise Therapy Spinal Elderly Orthosis: This orthosis is made of a dorsal, pelvic belt and ventricle. The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. The latest version of Spinal Elderly Orthosis is produced by the Iranian company Savad Teb. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic) . It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic) , which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month. Control group: Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed.The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month. Physical Fitness consist of muscle strength, mucsle endurance and balance. Timepoint: At the begining of the study, after 12 weeks and one year ( At the begining the duration of the follow up was 6 months but after covid 19 pandemic, sampling was incomplete and the time of final assessment was changed from 6 month to one year. According to ethnic principles and to avoid endangering patients to come to Rasool Akram Hospital, which is the center of Corona, final assessments were performed by video call at home and inevitably, unmeasurable variables at home were eliminated in the final evaluation.). Method of measurement: Muscle Strength by Dynamometer & Weight Machine, Muscle Endurance by 6 MWT( 6 minute walk test), Balance by Berg Balance Scale. Senior Fitness Test to Strength, Flexibility, Agility, Cardiopulmonary Fitness, Dynamic Balance. Respiratory Capacity. Timepoint: At the begining of the study , after 12 weeks (Inevitably final assessment was eliminated due to covid 19 pandemic). Method of measurement: Spirometry. Kyphosis Angle. Timepoint: At the begining of the study , after 12 weeks. Method of measurement: Inclinometer Device and X-ray (X-ray only at the begining and one year). Iran University of Medical Sciences Approved 2019-10-20 Ethics committe of Iran University of Medical Sciences Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave تهران Tehran Iran (Islamic Republic of)