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IRCT20251120068059N1 IRCT 2025-12-25 Babol University of Medical Sciences The effectiveness of physical and cognitive rehabilitation in improving performance in the elderly Comparing the effectiveness of physical and cognitive rehabilitation using in-person, hybrid, and virtual methods in improving occupational and cognitive performance in the elderly 2025-12-22 anticipated 117 Recruiting https://irct.ir/trial/87908 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization will be used for allocation. This will be designed by a methodologist using the website SealedEnvelope.com, with a block size of 6. Allocation Concealment: To ensure allocation concealment, the randomization list will be held exclusively by the first supervisor (Principal Investigator). To conceal the randomization process, the type of intervention will be written on 117 paper cards and These cards will be placed inside opaque (non-transparent) paper envelopes. Only the first supervisor (Principal Investigator) will be aware of the corresponding codes. The cards will be arranged inside a box according to the order of the randomization list. Once the interviewer (student/executor) confirms a participant's eligibility, the first supervisor will provide them with the envelope. 3 elderly. Intervention 1: First intervention group: This group will receive physical and cognitive rehabilitation entirely through in-person sessions (12 sessions, each session lasting 60 minutes). Intervention 2: Second intervention group: This group will receive physical and cognitive rehabilitation training combined through in-person and virtual sessions (6 in-person sessions and 6 virtual sessions, each session lasting 60 minutes). Intervention 3: Control group: This group will receive physical and cognitive rehabilitation entirely through virtual sessions (12 sessions, each session lasting 60 minutes). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Koul
, Babol University of Medical Sciences ,Ganj Afrouz Ave
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9592 marycool79615@gmail.com Babol University of Medical Sciences scientific Maryam Koul
, Babol University of Medical Sciences ,Ganj Afrouz Ave
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9592 marycool79615@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age over 60 years Informed consent to participate Absence of cognitive impairment based on the MMSE (Mini-Mental State Examination) Ability to attend intervention sessions and complete assessments. 60 years no limit Both Presence of a definitive diagnosis of dementia or other neuropsychiatric disorders. Debilitating physical illness that prevents attendance at sessions. Severe visual, hearing, or speech impairments that make test administration impossible. Rehabilitation Rehabilitation Rehabilitation First intervention group: This group will receive physical and cognitive rehabilitation entirely through in-person sessions (12 sessions, each session lasting 60 minutes). Second intervention group: This group will receive physical and cognitive rehabilitation training combined through in-person and virtual sessions (6 in-person sessions and 6 virtual sessions, each session lasting 60 minutes). Control group: This group will receive physical and cognitive rehabilitation entirely through virtual sessions (12 sessions, each session lasting 60 minutes). Occupational Performance. Timepoint: Occupational performance outcome measures are measured at the beginning of the study (before the intervention begins), 6 weeks after the intervention begins, 12 weeks after the intervention begins (completion of the intervention), and 3 months after the end of the intervention. Method of measurement: Canadian Occupational Performance Measure questionnaire. Cognitive flexibility. Timepoint: at baseline (before the intervention), 6 weeks after the intervention, 12 weeks after the intervention (completion of the intervention), and 3 months after the intervention. Method of measurement: Wisconsin Card Sorting Test. Cognitive inhibition. Timepoint: at baseline (before the intervention), 6 weeks after the intervention, 12 weeks after the intervention (completion of the intervention), and 3 months after the intervention. Method of measurement: Stroop Test. Working Memory. Timepoint: at baseline (before the intervention), 6 weeks after the intervention, 12 weeks after the intervention (completion of the intervention), and 3 months after the intervention. Method of measurement: Adults Working Memory Questionnaire. Babol University of Medical Sciences Approved 2025-11-09 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, GanjAfrooz street, Babol Babol Mazandaran Iran (Islamic Republic of)