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IRCT20250326065160N1 IRCT 2026-08-13 Tehran University of Medical Sciences Effect of a Lifestyle Program on Cognition and Daily Activities in People at Risk of Cognitive Decline Effectiveness of a Multi-Component Lifestyle Intervention on Cognitive Function and Instrumental Activities of Daily Living in Adults at Risk of Dementia 2026-04-21 anticipated 40 Complete https://irct.ir/trial/82596 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants will be allocated to the intervention and control groups in a 1:1 ratio using stratified block randomization. Stratification will be based on cognitive impairment type (MCI or SCD), with blocks of four used to maintain balance between the groups. Separate computer-generated randomization sequences will be prepared for each stratum by an independent individual. Allocation codes will be placed in sequentially numbered, opaque, sealed envelopes. Following enrollment and baseline assessment, the randomization officer will open the next envelope corresponding to the participant’s stratum and inform the principal investigator of the group assignment, Blinding description: Due to the nature of the intervention, blinding of participants and the interventionist will not be feasible, as they will be aware of the intervention being received or delivered. However, the assessor of participants’ cognitive and daily functioning will remain blinded to group allocation and will not have access to the randomization records. Participants will also be instructed not to disclose their group assignment or details of the intervention during the assessments. The assessor is an occupational therapist with two years of experience in clinical cognitive assessment and certification in administering the MoCA. The intervention will be delivered by an occupational therapist with two years of experience in geriatric care. Any accidental unblinding of the assessor will be documented. In addition, the statistical analyst will receive coded group data and remain blinded to group allocation until the primary analyses have been completed. N/A Condition 1: dementia. Condition 2: mild cognitive disorder. Intervention 1: Intervention group: In addition to usual services provided by participating older-adult day centers, participants will receive a structured multicomponent lifestyle intervention over a 7-week study period. The program includes 12 active 90-minute intervention sessions delivered twice weekly, in addition to pre- and post-intervention assessments. The intervention comprises: (1) computerized and non-computerized cognitive training targeting memory, attention, working memory, problem solving, cognitive flexibility, and executive functions; (2) individually adapted low- to moderate-intensity aerobic, stretching, and resistance exercise; (3) healthy lifestyle education addressing diet, sleep, stress management, cardiovascular health, and physical activity with weekly behavioral goal setting; and (4) structured social engagement through group discussion, games, team problem solving, reminiscence, and social activities. Home assignments and adherence to the intervention components will be regularly monitored. Intervention 2: Control group: participants allocated to the control arm will continue to receive the usual services routinely provided by the participating older-adult day centers during the study period. They will not receive any of the study-specific structured multicomponent lifestyle sessions, including the study cognitive training program, structured physical activity program, healthy lifestyle education program, or structured social engagement intervention during the active trial period. Participants in the control group will undergo the same pre- and post-intervention assessments as the intervention group. After completion of the post-intervention assessments, the multicomponent lifestyle program may be offered to control participants who wish to receive it. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD), including key outcomes, demographic variables, and cognitive and functional assessment results, will be made available upon request. Additionally, supporting documentation such as the statistical analysis plan, analysis code (upon request), and clinical outcome reports will be shared. Data will be accessible for up to 3 years post-publication via formal request and with approval from the ethics committee. Access will be granted to qualified researchers for legitimate academic purposes. When: Access to de-identified participant data, statistical analysis outputs, and related documents will begin 6 months after publication of the final results and will remain available for a period of 3 years. Access will be granted upon formal request and subject to ethical approval. To whom: Data and related documentation will be made available only to researchers affiliated with recognized academic, medical, or research institutions. Industry-based researchers may also apply, provided they submit a well-defined research proposal, obtain ethics approval, and collaborate with an academic or scientific entity. All data must be used strictly for non-commercial, scientific purposes only. Conditions: The shared data may only be used for non-commercial, scientific, and research purposes. Analyses must be limited to secondary research aligned with the original study’s aims or closely related research questions. Meta-analyses, academic training, and systematic reviews are permitted with proper citation. Any use that violates participant privacy, research ethics, or informed consent agreements is strictly prohibited. Data may not be re-shared with third parties without prior written approval. Requirements for data access request: Submission of a formal request with an institutional affiliation letter A detailed research proposal outlining objectives, methodology, and type of intended analyses A valid ethical approval from a recognized ethics committee A signed data use and confidentiality agreement Acceptance of review and possible rejection by the principal research team based on ethical/scientific grounds Where to obtain: Contact Information for Data Access Requests: Applicants interested in accessing participant data or related study documents may proceed through the following channels (in order of priority): Official email request: How to obtain: Process for Requesting and Receiving Data/Documents: To access de-identified data or study documentation, applicants must complete the following steps: Submit a formal request via email or post, including: A full research proposal (objectives, methodology, intended analyses) Institutional affiliation letter Ethics committee approval Confidentiality agreement (a template will be provided, if needed) Initial review by the research team within 7 working days, to assess ethical and scientific compatibility Feedback and (if approved) provision of the confidentiality agreement for applicant signature Delivery of data/documents within 10–14 working days of receiving complete documentation and signed agreement ✅ If all documents are submitted properly, the total turnaround time for access is estimated at 2 to 3 working weeks. 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public Fereshteh Torki
Student dormitory, Tehran University of Medical Sciences Residential Complex, Jalal Al-e-Ahmad Expressway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733171 +98 24 3525 1316 fereshteh914turki@gmail.com Tehran University of Medical Sciences scientific Fereshteh Torki
Tehran university of medical sciences dormitory, North Kargar St., Tehran
Tehran Iran (Islamic Republic of) 1419733171 +98 24 3525 1316 fereshteh914turki@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Aged 55 years and older Able to perform self-care activities independently The individual must have difficulty performing at least one Instrumental Activity of Daily Living (IADL) MoCA score between 19 and 24 MoCA score above 24 accompanied by the following two criteria: Persistent self-experienced cognitive decline compared to the individual's previous normal state, not attributable to an acute event, as measured by the Jessen criteria A score of 0.5 on the Clinical Dementia Rating (CDR) scale 55 years no limit Both History of severe psychiatric disorders or neurological conditions Physical disability or any condition that limits physical activity Participation in a similar intervention program Unwillingness to participate in the study F00 F06.7 Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years. A disorder characterized by impairment of memory, learning difficulties, and reduced ability to concentrate on a task for more than brief periods. There is often a marked feeling of mental fatigue when mental tasks are attempted, and new learning is found Prevention Rehabilitation Intervention group: In addition to usual services provided by participating older-adult day centers, participants will receive a structured multicomponent lifestyle intervention over a 7-week study period. The program includes 12 active 90-minute intervention sessions delivered twice weekly, in addition to pre- and post-intervention assessments. The intervention comprises: (1) computerized and non-computerized cognitive training targeting memory, attention, working memory, problem solving, cognitive flexibility, and executive functions; (2) individually adapted low- to moderate-intensity aerobic, stretching, and resistance exercise; (3) healthy lifestyle education addressing diet, sleep, stress management, cardiovascular health, and physical activity with weekly behavioral goal setting; and (4) structured social engagement through group discussion, games, team problem solving, reminiscence, and social activities. Home assignments and adherence to the intervention components will be regularly monitored. Control group: participants allocated to the control arm will continue to receive the usual services routinely provided by the participating older-adult day centers during the study period. They will not receive any of the study-specific structured multicomponent lifestyle sessions, including the study cognitive training program, structured physical activity program, healthy lifestyle education program, or structured social engagement intervention during the active trial period. Participants in the control group will undergo the same pre- and post-intervention assessments as the intervention group. After completion of the post-intervention assessments, the multicomponent lifestyle program may be offered to control participants who wish to receive it. Global cognitive. Timepoint: pre and post intervention. Method of measurement: MoCA test. Instrumental Activities of Daily Living. Timepoint: pre and post intervention. Method of measurement: Bayer-ADL. Executive functions. Timepoint: pre and post intervention. Method of measurement: BRIEF-A. Attention. Timepoint: pre and post intervention. Method of measurement: Stroop Color and Word Test. Working memory. Timepoint: pre and post intervention. Method of measurement: Digit Span Test. Processing speed. Timepoint: pre and post intervention. Method of measurement: Stroop Color and Word Test. Cognitive flexibility. Timepoint: pre and post intervention. Method of measurement: Stroop Color and Word Test. Tehran University of Medical Sciences Approved 2025-03-22 Ethics committe of Tehran University of Medical Sciences No 1470, North Kargar St, Tehran Tehran Tehran Iran (Islamic Republic of)