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IRCT20260624069940N1 IRCT 2026-07-23 Tarbiat Modares University Comparison of the Effects of Two Training Methods on Brain Function, Dual-Task Performance, and Quality of Life in Elderly Men Comparing the Effects of Two Training approaches: Low-Intensity Steady-State Training versus Functional Training on Cognitive Function, Dual Task Performance and Quality of Life in Elderly Men 2026-08-06 anticipated 45 Complete https://irct.ir/trial/91659 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: None, Randomization description: After initial screening and confirmation of participants' eligibility, the names of eligible individuals are written on separate pieces of paper. Then, through a lottery method, each participant is randomly allocated to one of three groups (Low-Intensity Steady-State Training, Functional Training, and Control Group). Randomization method: Simple Randomization Randomization unit: Individual Stratification factors: None (no stratified randomization) Randomization tool: Lottery (using separate paper slips) Sequence generation method: Using lottery method without using software or random number tables Allocation concealment: Since allocation is performed through lottery and the slips are prepared by an independent person and placed in a sealed container before selection, the allocation cannot be predicted by the researcher or participants, thus allocation concealment is ensured, Blinding description: In this study, due to the nature of the exercise intervention, complete blinding for all groups is not possible. However, to reduce bias in outcome assessment, the Outcome Assessors, who are responsible for administering the cognitive tests, dual-task assessments, and quality of life questionnaires, will be blinded to the group allocation of participants. Detailed explanation by role: Participants: Not blinded. Participants are aware of the type of exercise they are performing (Low-Intensity Steady-State Training, Functional Training, or Control). Principal Investigator and Exercise Trainers: Not blinded. The researcher and exercise trainers who are responsible for conducting the training sessions are aware of the type of intervention each group receives. Personnel (Center Physician): Not blinded. The physician who monitors participants' health and conducts initial examinations is aware of the intervention type. Medical supervision is essential for participant safety. Outcome Assessors: Blinded. Individuals who administer and score the cognitive tests (MMSE, Digit Span, Stroop, CVLT, WCST), dual-task assessments, and quality of life questionnaire (SF-36) will be unaware of the participants' group allocation. These individuals are not involved in the exercise intervention process and only interact with participants during pre-test and post-test assessments. Data Analyst: Not blinded. The person analyzing the data is aware of the group allocation. Data Safety and Monitoring Committee (DSMB): Not applicable in this study. Method of blinding for Outcome Assessors: Outcome assessors will be kept blinded through participant coding and lack of access to group allocation information. After randomization, each participant receives a unique code, and the assessors only work with these codes, without knowing which code belongs to which group. N/A Age-related cognitive decline. Intervention 1: Intervention group: Low‑intensity steady‑state training for 8 weeks, three sessions per week, each session lasting 45 minutes. Each session includes 10 minutes of warm‑up with light walking and dynamic stretching, 30 minutes of main exercise including treadmill walking, stationary cycling, and stair stepper at an intensity of 40‑65% of maximum heart rate (increasing by 5% every two weeks), and 5 minutes of cool‑down with light walking and static stretching. In case of physical weakness, the intensity is maintained at 40‑50% of maximum heart rate. Intervention 2: Intervention group: Functional training for 8 weeks, three sessions per week, each session lasting 45 minutes. Each session includes 10 minutes of warm‑up with light walking and dynamic stretching, 30 minutes of functional exercises including balance exercises (single‑leg stance, heel‑toe walking, side walking), strength exercises (squats, lunges, sit‑to‑stand, core and spinal extensor strengthening), coordination exercises (throwing and catching a ball, walking between obstacles), and simulation of daily activities (picking up an object from the floor, 180‑degree turn) with progressive overload across different weeks, and 5 minutes of cool‑down with light walking and static stretching. Intervention 3: Control group: Participants in this group receive no structured training intervention and are asked to continue their normal daily activities throughout the 8‑week study period. After the study completion, if the interventions prove effective, the beneficial training program will be offered to this group as well. Yes - There is a plan to make this available What will be shared: Data Dictionary and Variable Coding System: Includes variable names, data types, value ranges, measurement methods, and operational definitions of all primary and secondary outcome variables (cognitive function, dual-task performance, and quality of life). When: Six months after publication of study results To whom: Researchers affiliated with reputable academic and scientific institutions who have an approved research proposal by their institutional ethics committee. Conditions: Data may be used solely for research purposes and secondary analyses related to aging and exercise physiology. Commercial use of the data is not permitted. All users must adhere to ethical requirements and maintain data confidentiality, and must report any findings from their analyses to the primary authors. Where to obtain: To request data, please contact the corresponding author, Mr. Jaafar Jameel Abdolkaadim, via email at jameel.jaafar@modares.ac.ir. Requests may also be submitted through the Department of Exercise Sciences at Tarbiat Modares University. How to obtain: Upon submission of a request via email, the corresponding author will review the application. After approval by the university ethics committee, the request will be forwarded to the research team. If finally approved, de-identified data will be provided within two to four weeks via email or a secure data-sharing platform. Comments: Data will be provided solely for non-commercial purposes, with full adherence to ethical principles and confidentiality of participant information.
public Jaafar Jameel Abdolkaadim
Tarbiat Modares University, Shahid Chamran Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۱۵۱۱۱۱ +98 21 8288 5063 jameel.jaafar@modares.ac.ir Tarbiat Modares University scientific Dr. Shahnaz Shahrbanian
Tarbiat Modares University, Shahid Chamran Blvd., Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۱۵۱۱۱۱ +98 21 8288 5063 sh.shahrbanian@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Elderly men aged between 60 and 75 years Ability to walk independently without using assistive devices No active or uncontrolled cardiovascular diseases (confirmed by medical examination) No severe neurological or muscular disorders that prevent performing exercises (e.g., Parkinson's disease or stroke) No uncontrolled diabetes (confirmed by a physician) Systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg (controlled) No history of stroke or seizures in the past year No participation in regular exercise programs (more than 150 minutes per week) in the last three months Ability to understand and cooperate in performing tests and exercises Signed written informed consent to participate in the study Negative answers to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) Taking fewer than 4 steps in the 180-degree turn test No use of anti-inflammatory or steroidal drugs that affect physiological indicators (confirmed by a physician) 60 years 75 years Male History of spinal or other joint surgery within the last 12 months Presence of open wound on the foot Plantar fasciitis Fixed foot deformity (acquired or congenital) History of serious mental illness Severe visual impairment that prevents performing exercises Severe hearing impairment that prevents performing exercises Cardiorespiratory diseases that limit exercise tolerance R41.81 Age-related cognitive decline (کاهش شناختی مرتبط با سن) Behavior Behavior Other Intervention group: Low‑intensity steady‑state training for 8 weeks, three sessions per week, each session lasting 45 minutes. Each session includes 10 minutes of warm‑up with light walking and dynamic stretching, 30 minutes of main exercise including treadmill walking, stationary cycling, and stair stepper at an intensity of 40‑65% of maximum heart rate (increasing by 5% every two weeks), and 5 minutes of cool‑down with light walking and static stretching. In case of physical weakness, the intensity is maintained at 40‑50% of maximum heart rate. Intervention group: Functional training for 8 weeks, three sessions per week, each session lasting 45 minutes. Each session includes 10 minutes of warm‑up with light walking and dynamic stretching, 30 minutes of functional exercises including balance exercises (single‑leg stance, heel‑toe walking, side walking), strength exercises (squats, lunges, sit‑to‑stand, core and spinal extensor strengthening), coordination exercises (throwing and catching a ball, walking between obstacles), and simulation of daily activities (picking up an object from the floor, 180‑degree turn) with progressive overload across different weeks, and 5 minutes of cool‑down with light walking and static stretching. Control group: Participants in this group receive no structured training intervention and are asked to continue their normal daily activities throughout the 8‑week study period. After the study completion, if the interventions prove effective, the beneficial training program will be offered to this group as well. Cognitive Function. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: Mini Mental State Examination for global mental status; Digit Span test for working memory; Stroop test for information processing speed; California Verbal Learning Test for long-term memory; Wisconsin Card Sorting Test for executive functions. Dual-Task Performance. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: Measuring gait speed in single-task and dual-task conditions (while counting backwards); measuring throwing accuracy in single-task and dual-task conditions (while naming words). Quality of Life. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: SF-36 Quality of Life Questionnaire (36 items in eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional health, and mental health). Global Mental Status. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: Mini Mental State Examination (30 items in five domains: orientation to time and place, short-term memory registration, attention and calculation, memory recall, and language and visuospatial skills). Working Memory. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: Digit Span Test (including forward and backward digit repetition, administered aurally). Information Processing Speed. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: Stroop Test (including four cards, measuring reaction time and number of errors). Long-Term Memory. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: California Verbal Learning Test (including word list presentation, immediate recall, short-term recall, cued recall, and delayed recall). Executive Functions. Timepoint: Before the intervention and after 8 weeks of intervention. Method of measurement: Wisconsin Card Sorting Test (including 128 cards, measuring correct responses, completed categories, perseverative errors, and failure to maintain set). Tarbiat Modares University Approved 2026-05-25 Research Ethics Committee of Tarbiat Modares University Tarbiat Modares University, Shahid Chamran Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)