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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151122025191N3
Enrollment
196
Registered
2022-05-07
Start date
2022-05-22
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major neurocognitive disorder. Dementia in other diseases classified elsewhere

Interventions

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 tho

Sponsors

Department of health and ageing - Department of population, family and school health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 74 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnam Shariati

Iran University of Medical Sciences

behnamshariatimd@gmail.com+98 21 6655 1655

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026