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IRCT20190908044722N1 IRCT 2019-12-24 Faculty of Physical Education and Sport Sciences, University of Tehran,Tehran, Iran The Effectiveness of Three Interventions on Balance, Gait and Cognition among Man Schizophrenia Patients with Depression Disorder The Effectiveness of Aerobic Exercise, Computerized Cognitive Rehabilitation, tDCS on Balance, Gait and Cognition among Man Schizophrenia Patients with Depression Disorder 2019-07-02 anticipated 60 Complete https://irct.ir/trial/42041 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A schizophrenia. Intervention 1: Intervention group 1:Aerobic training group: Participants will been enrolled in AT will undergo a 12-week, 3 sessions per week, 1-h AT training program informed by the American College of Sports Medicine and federal guidelines which recommend 150 min of moderate-intensity AT per week. The AT sessions will been led by a trainer (Bachelor of Physical Eduation) and will been opened with a10-min trainer-led warm-up (stretching, slow walking) period, will been followed by 45-min AT using the equipment, and will been ended with a 5-min cooldown period The AT equipment will include two stationary bike,a treadmill machine. The trainer will be present during the AT sessions for guidance and support. AT intensity will be set to 60% of Hrmax in Week 1, 65% of Hrmax in Week 2, 70% of Hrmax in Week 3, and 75% of Hrmax in Weeks 4–12. Intervention 2: Intervention group 2: computerized cognitive training group : Cognitive rehabilitation was carried out using a cognitive rehabilitation program called the Attentive Rehabilitation of Attention and Memory (ARAM). This program is a kind of software designed to enhance the cognitive abilities created by Nejati and in some reports, its effectiveness was shown on executive functions.The program included a group of organized hierarchical tasks that enhanced the various dimensions of attention (selective, sustained, shifting, and divided) and working memory. These practices are hierarchical. This means that the therapist records the information obtained from the evaluation of the sessions, including the percentage of the correct responses of the client and task completion speed. If the client masters a task, the therapist increases the diffculty level of the task. Participations will been enrolled in CCT will attend in the computerized cognitive training session for 45–60 minutes three times weekly for 12 weeks (36 total sessions). Intervention 3: Intervention group 3: a-tDCS group: The anode stimulstion group will receive on the motor and pre-motor region for 24 sessions, two times weekly over 12 weeks. That way, in the morning will been given stimulation of the right hemisphere and in the afternoon will been given stimulation of the left area .The anode electrode will been placed on the motor and pre-motor and the cathode electrode will been placed in the center of the forehead. Also, the a-tDCS group, will receive stimulation on F3 for 24 sessions, two times weekly over 12 weeks. The anode will been placed over the left DlPFC and the cathode will been placed on the contralateral deltoid muscle.The maximum current intensity will be 2 mA. Intervention 4: Intervention group4: multidimensional training group : The multidimensional training consist of aerobic training, cognitive training, and direct electrical stimulation of the brain. Participations will been enrolled in MT will attend in the computerized cognitive training session for 10 minutes 3 times weekly for 12 weeks (36 total sessions). Also, They will undergo a 8 weeks, 2 sessions per week, 1-h AT training program. Minimal AT intensity will be set to 60% of Hrmax in Week 1, 65% of Hrmax in Week 2, 70% of Hrmax in Week 3, and 75% of Hrmax in Weeks 4–12. During the exercise sessions, heart rate will been monitored using a Beurer PM 15 Heart Monitor. Participants will receive stimulation at the motor and pre-motor point in the right and left hemispheres from 9th to 12 th week. In the morning area will been given stimulation of the right hemisphere and in the afternoon stimulation of the left area . The anode electrode will been placed on the (M1) motor and pre-motor region and the cathode electrode will been placed in the center of the forehead. Also Participants will receive stimulation on F3 for 12 sessions during 4 weeks (3 times per week). Electrode anode will been placed on the left posterior frontal cortex And the cathode electrode will been placed on the opposite side of the deltoid muscle. Intervention 5: control group: Routine care. Yes - There is a plan to make this available What will be shared: The analysis of information obtained from the results of the interventions on balance and gait speed can be published When: From the time the article was published until a year later To whom: All researchers Conditions: Provided Someone wants to do a similar research project Where to obtain: r.khanmohamadi65@yahoo.com How to obtain: Send request by email Comments:
public Razieh Khanmohammadi
Between Fifteenth and Sixteenth St, Amirabad St, Tehran, Iran
Tehran Iran (Islamic Republic of) 3813978344 +98 918 624 2003 r.khanmohamadi65@yahoo.com University of Tehran scientific Razieh Khanmohammadi
Between Fifteenth and Sixteenth St, Amirabad St, Tehran, Iran
Tehran Iran (Islamic Republic of) 3813978344 +98 86 3221 4311 r.khanmohamadi65@yahoo.com University of Tehran Iran (Islamic Republic of) Fulfillment of DSM-IV criteria for schizophrenia The age 18–65 years The ability to understand and speak Get a score of 11 or above on the Mini-Mental State Examination Get a score of 11 or above on the Beck Depression Inventory Having physical health, meaning that they have no evidence of cardiovascular, neuromuscular, endocrine or another somatic disorders 18 years 65 years Male Alcohol or substance dependence in the past 3 months Substance dependence with current substance abuse (excluding nicotine) History of head injury Previous seizures Having brain implants, cardiac pacemakers Use of antiepileptic drugs or benzodiazepines > 1 mg Lorazepam equivalent Having severe diabetes and asthma Diagnosis of acute schizophrenia requiring hospitalization, presence of severe schizophrenic symptoms (e.g. persistent withdrawal) that would limit participation in class A history of organic mental disorders (e.g. mental retardation or dementia), presence of physical disabilities Untreated hyper- or hypothyroidism Extreme obesity (BMI ≥ 40); Concurrent participation in another study F98 Other behavioral and emotional disorders with onset usually occurring in childhood and adolescence Rehabilitation Rehabilitation Treatment - Devices Rehabilitation Other Intervention group 1:Aerobic training group: Participants will been enrolled in AT will undergo a 12-week, 3 sessions per week, 1-h AT training program informed by the American College of Sports Medicine and federal guidelines which recommend 150 min of moderate-intensity AT per week. The AT sessions will been led by a trainer (Bachelor of Physical Eduation) and will been opened with a10-min trainer-led warm-up (stretching, slow walking) period, will been followed by 45-min AT using the equipment, and will been ended with a 5-min cooldown period The AT equipment will include two stationary bike,a treadmill machine. The trainer will be present during the AT sessions for guidance and support. AT intensity will be set to 60% of Hrmax in Week 1, 65% of Hrmax in Week 2, 70% of Hrmax in Week 3, and 75% of Hrmax in Weeks 4–12 Intervention group 2: computerized cognitive training group : Cognitive rehabilitation was carried out using a cognitive rehabilitation program called the Attentive Rehabilitation of Attention and Memory (ARAM). This program is a kind of software designed to enhance the cognitive abilities created by Nejati and in some reports, its effectiveness was shown on executive functions.The program included a group of organized hierarchical tasks that enhanced the various dimensions of attention (selective, sustained, shifting, and divided) and working memory. These practices are hierarchical. This means that the therapist records the information obtained from the evaluation of the sessions, including the percentage of the correct responses of the client and task completion speed. If the client masters a task, the therapist increases the diffculty level of the task. Participations will been enrolled in CCT will attend in the computerized cognitive training session for 45–60 minutes three times weekly for 12 weeks (36 total sessions). Intervention group 3: a-tDCS group: The anode stimulstion group will receive on the motor and pre-motor region for 24 sessions, two times weekly over 12 weeks. That way, in the morning will been given stimulation of the right hemisphere and in the afternoon will been given stimulation of the left area .The anode electrode will been placed on the motor and pre-motor and the cathode electrode will been placed in the center of the forehead. Also, the a-tDCS group, will receive stimulation on F3 for 24 sessions, two times weekly over 12 weeks. The anode will been placed over the left DlPFC and the cathode will been placed on the contralateral deltoid muscle.The maximum current intensity will be 2 mA. Intervention group4: multidimensional training group : The multidimensional training consist of aerobic training, cognitive training, and direct electrical stimulation of the brain. Participations will been enrolled in MT will attend in the computerized cognitive training session for 10 minutes 3 times weekly for 12 weeks (36 total sessions). Also, They will undergo a 8 weeks, 2 sessions per week, 1-h AT training program. Minimal AT intensity will be set to 60% of Hrmax in Week 1, 65% of Hrmax in Week 2, 70% of Hrmax in Week 3, and 75% of Hrmax in Weeks 4–12. During the exercise sessions, heart rate will been monitored using a Beurer PM 15 Heart Monitor. Participants will receive stimulation at the motor and pre-motor point in the right and left hemispheres from 9th to 12 th week. In the morning area will been given stimulation of the right hemisphere and in the afternoon stimulation of the left area . The anode electrode will been placed on the (M1) motor and pre-motor region and the cathode electrode will been placed in the center of the forehead. Also Participants will receive stimulation on F3 for 12 sessions during 4 weeks (3 times per week). Electrode anode will been placed on the left posterior frontal cortex And the cathode electrode will been placed on the opposite side of the deltoid muscle control group: Routine care Static balance. Timepoint: Before the intervention and after the intervention. Method of measurement: The test of standing on dominant foot with open and closed eyes. Dynamic Balance. Timepoint: Before the intervention and after the intervention. Method of measurement: The Test of Timed up and Go. 10-meter gait speed. Timepoint: Before the intervention and after the intervention. Method of measurement: The Test of 10-meter gait speed. Of 10-meter gait speed under visuospatial dual-task condition. Timepoint: Before the intervention and after the intervention. Method of measurement: The Test of 10-meter gait speed under visuospatial dual-task condition. Of 10-meter gait speed under motor dual-task condition. Timepoint: Before the intervention and after the intervention. Method of measurement: The Test of 10-meter gait speed under motor dual-task condition. Sustain attention. Timepoint: One month before intervention and two weeks after intervention. Method of measurement: Continuous Performance Test. Response Inhibition. Timepoint: One month before intervention and two weeks after intervention. Method of measurement: Stroop Test. Working Memory. Timepoint: One month before intervention and two weeks after intervention. Method of measurement: N-back Test. Faculty of Physical Education and Sport Sciences, University of Tehran,Tehran, Iran Approved 2019-07-01 Ethics committee of Sport Sciences Research Institute No. 3, Fifth Alley, Miramad Street, Tehran Tehran Tehran Iran (Islamic Republic of)