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IRCT20151122025191N3 IRCT 2022-05-07 Department of health and ageing - Department of population, family and school health Evaluation of Efficacy of multidomain interventions of diet, exercise, managing of vascular risk factors and cognitive training to prevent cognitive decline in Iranian older adults Evaluation of Efficacy of multidomain interventions of diet, exercise, managing of vascular risk factors and cognitive training to prevent cognitive decline in Iranian older adults 2022-05-22 anticipated 196 Complete https://irct.ir/trial/56542 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Restricted randomization with the permuted block method was used to create the random sequence and balance the number of allocated samples in each group (control and intervention). The Excel was used for a random sequence in blocks of 2, 4, and 6. Each block has an equal number of control and HemoHIM groups. It is written on the cards and placed respectively for hiding in locked opaque packets. A packet was selected for each patient according to the study recruitment, which determines the related study group.In this way, we will have two groups of 98 that are assigned completely randomly, Blinding description: To do study with concealment, table of block will be used by one of researchers, other than interviewer and who assess patients in follow-up visits. Therefore, interviewer and who evaluates patients in follow-up visits will be unaware if each number belongs to which groups. 3 Major neurocognitive disorder. Intervention 1: Intervention group: In the intervention group of vascular risk factors management intervention, those who need medication for physical problems will be treated with medication. For those who suffer from mild to moderate psychiatric disorder, medication will prescribe by the study psychiatrist. In exercise intervention, after physical evaluation, the exercise program is given to participants in individual sessions by use of clips. these sessions will be held every two weeks in the first month and then monthly. In nutritional intervention, after nutritional evaluation, if there is a nutritional deficiency, multivitamins will be prescribed. Nutritional sessions based on MIND diet will be held every two weeks in the first two months and then monthly. In cognitive training intervention, cognitive rehabilitation program will performed by the use from Rehocom cognitive rehabilitation software and the pencil and paper workbook. the individualized session will be held every week as well as group sessions at the beginning and month 3. Cognitive assessment will be performed by Addenbrooke’s cognitive examination and The Cambridge Neuropsychological Test Automated Battery, physical activity assessment will be performed by Barthel Index of Activities of Daily Living and Lawton instrumental activity of daily living and short physical performance battery scale, nutritional assessment will be performed by A Three-day food record form and Food frequency questionnaire. In addition to the baseline the evaluation will be repeated in the third and sixth months. Intervention 2: Control group: After initial assessments in the baseline, including physical, psychiatric, nutritional, exercise, and cognitive status assessments in all participants, individuals who are placed in the control group according to randomization will receive routine health advice. They are given a training pamphlet on risk factors for cognitive decline. If treatment is needed, they are advised to visit a relevant specialist.Then they will be re-evaluated at the third and sixth months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after being unidentified. When: Access will be allowed 3 month after publication. To whom: Researchers Conditions: For use in meta-analysis studies with a written request stating the reason for the request and documentation Where to obtain: Dr Behnam Shariati How to obtain: By Sending an email to the corresponding person along with mentioning the documents and the reason for the request. Comments:
public Behnam Shariati
School of Behavioral Sciences and Mental Health., Shahid Mansouri Street., Niyayesh Street., Satarkhan Avenue., Tehran., Iran
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 behnamshariatimd@gmail.com Iran University of Medical Sciences scientific Behnam Shariati
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 behnamshariatimd@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Aged 55 to 74 years. Having at least one modifiable dementia risk factor from among hypertension, diabetes mellitus, dyslipidemia, obesity, abdominal obesity, abdominal obesity, metabolic syndrome, smoking, educational level less than 9 years, physical inactivity, and social inactivity. No neurocognitive disorder detected by the psychiatrist with the use of DSM5 criteria at the base time. The score 85 or more in the Addenbrooke cognitive test at the base time. Able to independently perform the activities of daily living. Can read and write in Farsi. Able to participate in the exercise program safely. Having a reliable informant who can provide investigators with requested information. Providing written informed consent. 55 years 74 years Both Existence of major psychiatric illness such as major depressive disorder. Existence of other neurodegeneration disease such as Parkinson's disease. The history of malignancy within the previous 5 years. The history of cardiac stent or revascularization within the previous 1 year. Existence of serious or unstable medical disease such as acute or sever asthma, active gastric ulcer, sever liver disease, or sever renal disease. Existence of sever loss of vision or hearing, or communication disability. Existence of any conditions preventing cooperation as judged by the study physician. Existence of significant laboratory abnormality that may result in cognitive impairment. The simultaneous participation in any other intervention trial. F02 Dementia in other diseases classified elsewhere Prevention Prevention Intervention group: In the intervention group of vascular risk factors management intervention, those who need medication for physical problems will be treated with medication. For those who suffer from mild to moderate psychiatric disorder, medication will prescribe by the study psychiatrist. In exercise intervention, after physical evaluation, the exercise program is given to participants in individual sessions by use of clips. these sessions will be held every two weeks in the first month and then monthly. In nutritional intervention, after nutritional evaluation, if there is a nutritional deficiency, multivitamins will be prescribed. Nutritional sessions based on MIND diet will be held every two weeks in the first two months and then monthly. In cognitive training intervention, cognitive rehabilitation program will performed by the use from Rehocom cognitive rehabilitation software and the pencil and paper workbook. the individualized session will be held every week as well as group sessions at the beginning and month 3. Cognitive assessment will be performed by Addenbrooke’s cognitive examination and The Cambridge Neuropsychological Test Automated Battery, physical activity assessment will be performed by Barthel Index of Activities of Daily Living and Lawton instrumental activity of daily living and short physical performance battery scale, nutritional assessment will be performed by A Three-day food record form and Food frequency questionnaire. In addition to the baseline the evaluation will be repeated in the third and sixth months. Control group: After initial assessments in the baseline, including physical, psychiatric, nutritional, exercise, and cognitive status assessments in all participants, individuals who are placed in the control group according to randomization will receive routine health advice. They are given a training pamphlet on risk factors for cognitive decline. If treatment is needed, they are advised to visit a relevant specialist.Then they will be re-evaluated at the third and sixth months. Addenbrooke's Cognitive Examination Score. Timepoint: at the baseline, and the third and the sixth month after intervention. Method of measurement: Addenbrooke's Cognitive Examination-II Score. Cambridge Neuropsychological Test Automated Battery. Timepoint: At the baseline, the third and the sixth month after intervention. Method of measurement: CANTAB Cognitive Software. Barthel Index of Activities of Daily Living Score. Timepoint: At the baseline time, and the third and the sixth month after the start of intervention. Method of measurement: Barthel Index of Activities of Daily Living Questionnaire. Lawton instrumental activity of daily living diary Score. Timepoint: At the baseline time, and the third and the sixth month after the start of intervention. Method of measurement: Lawton instrumental activity of daily living diary Questionnaire. Short Physical Performance Battery Scale Score. Timepoint: At the baseline time, and the third and the sixth month after the start of intervention. Method of measurement: Short Physical Performance Battery Scale Questionnaire. Food Frequency Questionnaire Score. Timepoint: At the baseline time, and the third and the sixth month after the start of intervention. Method of measurement: Food Frequency Questionnaire. A Three Day Food Record Score. Timepoint: At the baseline time, and the third and the sixth month after the start of intervention. Method of measurement: A Three Day Food Record Questionnaire. Department of health and ageing - Department of population, family and school health Approved 2021-07-27 ethics committee of Iran University of Medical Sciences No. 28, 28th street, Arashmehr Ave., Jalal e Al e Ahmad Highway., Tehran Tehran Iran (Islamic Republic of)