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IRCT20240718062460N4 IRCT 2026-10-20 yasouj university The Effect of Cognitive and Physical Games on Mobility, Self-care, and Memory in Older Adults GAMOS: Gamification for Mobility, Older adults, and Self-care The effectiveness of gamification interventions on improving sedentary behaviors, self-care, and cognitive decline in the elderly: A Randomized Control trial study 2026-10-23 anticipated 190 Recruiting https://irct.ir/trial/94115 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The aim of this study is to evaluate the effectiveness of a non-pharmacological intervention (gamification) on improving sedentary behaviors, self-care, and cognitive function in older adults. This study does not aim to treat a specific disease, prevent disease occurrence, diagnose disease, or screen. Rather, its purpose is to improve physical and mental health, function, and quality of life in older adults and reduce complications associated with aging. Therefore, the option "Supportive Care (and Rehabilitation)" is the most appropriate classification for the primary purpose of this study, Randomization description: Randomization method: Block randomization was performed with variable block sizes of 4 and 6 and an allocation ratio of 1:1. No quasi-randomization methods were used. Unit of randomization: Individual. Stratification: Stratified randomization was not used for allocation. Randomization tool: Computer-generated random number software. Random sequence generation: The random sequence was generated by an independent statistician, separate from the research process, using computer-generated random number software, in random blocks of variable sizes of 4 and 6 with an allocation ratio of 1:1. The sequence was kept confidential until allocation. Allocation concealment: Allocation concealment was performed using opaque, numbered, and sealed envelopes. The contents of the envelopes were prepared by an individual independent of the research process, and the envelopes were numbered sequentially. The envelopes were impermeable to light, and the next numbered envelope was opened only after recording the participant’s name and details and obtaining informed consent, Blinding description: This study is single-blind. Only the outcome assessors and the data analyst are unaware of group allocation (data are analyzed using codes A/B). Participants, researchers, and intervention providers are not blinded due to the non-pharmacological and interactive nature of the study. There is no data monitoring committee. N/A Condition 1: Sedentary behaviors. Condition 2: Self-care. Condition 3: Cognitive Decline. Intervention 1: Intervention Group: The gamification intervention consists of 8 weeks, 3 sessions per week, with each session lasting 60 to 90 minutes. The sessions are held in groups of 10 to 15 older adults at local health centers in Yasouj. The structure of each session includes the following components: Warm-up and review of weekly assignments: 10 minutes Gamified physical activity: 20 to 30 minutes, including balance, strength, and aerobic exercises with game elements such as team challenges, individual competition, and receiving badges Gamified cognitive training: 20 to 30 minutes, including group mental games such as memory, attention, and problem-solving with challenge cards and scoring Group discussion and self-care: 10 minutes, including exchanging experiences about medication management, nutrition, sleep, and mental health using educational cards Summary and setting individual challenges for the next week: 5 minutes The scoring system is designed based on the Octalysis framework. Each participant receives 140 base points at the beginning of the week. Completing the daily assignment earns 10 points, completing the group assignment earns 10 points, attending the session earns 5 points, active participation earns 5 to 10 points, and winning the group challenge earns 10 bonus points. If the daily assignment is not completed, 20 points are deducted. Progress levels include Beginner from 0 to 200 points, Silver from 201 to 500 points, Gold from 501 to 800 points, and Platinum from 801 points and above. Badges include the First Step badge for completing the first week of the intervention, the Teamwork badge for the highest cooperation with the team, and the Persistence badge for attending all sessions. Between-session assignments include daily walking for at least 30 minutes using a pedometer, performing a simple mental game such as crossword puzzles or Sudoku, and recording medication intake, sleep quality, nutrition, and self-care status in self-care cards. Intervention 2: Control group: The control group receives only routine care. This care consists of a general health education session and the provision of a pamphlet on a healthy lifestyle. Additionally, they are provided with a pedometer to track their daily step count; however, no gamification interventions are implemented for them. Yes - There is a plan to make this available What will be shared: Title and Further Details about the Data/Document - English: Document Title: De-identified individual participant data and supporting trial documents. Details: After the study completion and publication of the main results, de-identified individual participant data (without name, national ID, address, and contact information) can be shared. These data include demographic information, scores of the Physical Activity Scale for the Elderly, the Self-Care Ability Scale for the Elderly, the Montreal Cognitive Assessment, and pedometer data. Access is provided only after a written request from eligible researchers, approval by the ethics committee, and signing a confidentiality agreement. Raw data that can identify individuals and identity information will not be shared under any circumstances. When: Data access will begin 6 months after the publication of the main study results and will remain available for 5 years. To whom: Access to de-identified data is possible only for researchers working in academic and scientific institutions, after submitting a written request, approval by the ethics committee, and signing a confidentiality agreement. Individuals working in industry or other non-scientific organizations are not permitted to receive the data. Conditions: The de-identified data and study documents may be used only for non-commercial research purposes, including secondary analyses, meta-analyses, verification of findings, and advancing scientific knowledge in the field of older adult health. Commercial, industrial, or for-profit use of the data is prohibited. Conditions of use include: Submitting a written request stating the specific research purpose. Obtaining approval from the requesting institution's ethics committee. Signing a data use agreement that includes a commitment not to attempt re-identification of individuals, not to transfer the data to third parties, and to cite the original study in publications. Publishing results from secondary analyses only with citation of the original study as the data source. Not using the data for clinical, diagnostic, or commercial purposes. Full compliance with confidentiality and research ethics principles. Where to obtain: Applicants may request access to the de-identified data or study documents in the following order: Submit a written request via email to the principal investigator: Dr. Ayoub Hashemi Email: a.hashemi@yu.ac.ir Send an official letter by post to: Yasuj University, Daneshjoo Street, Yasuj, Iran Postal Code: 7591874934 Attention: Dr. Ayoub Hashemi Call Yasuj University for further guidance: Phone: 0098 74 33221000 Visit the university website for additional contact information: www.yu.ac.ir Applicants must state in their request the research purpose, their affiliated institution, and their commitment to confidentiality principles and the conditions of use. How to obtain: The process for requesting access to de-identified data or study documents is as follows: Submit a written request: The applicant sends a request via email to the principal investigator (Dr. Ayoub Hashemi, a.hashemi@yu.ac.ir). The request must include the applicant's name and affiliated institution, specific research purpose, type of data or documents needed, approval from the applicant's institutional ethics committee, and a commitment to confidentiality and conditions of use. Acknowledgement of receipt: The research team acknowledges receipt of the request within a maximum of 5 working days. Initial review: The principal investigator and research team review the request for alignment with study objectives, non-commercial use conditions, and completeness of documents. This stage takes 1 to 2 weeks. Referral to the ethics committee: If initially approved, the request is referred to the Ethics Committee of Yasuj University for final approval. This stage takes 2 to 4 weeks. Notification of outcome: The outcome (approval, rejection, or need for revision) is communicated to the applicant. Signing the data use agreement: If approved, the applicant and their institution must sign a data use agreement that includes a commitment not to attempt re-identification, not to transfer data to third parties, and to cite the original study in publications. Data preparation: The de-identified data and requested documents are prepared by the research team. This stage takes 1 to 2 weeks. Secure data delivery: Data are delivered via an encrypted link or the secure server of Yasuj University. This stage takes about 1 week. Total timeframe: If the request is complete, the entire process usually takes 6 to 10 weeks. Incomplete requests or those requiring revision take longer. Also, access to data before the end of the embargo period (6 months after publication of the main results) is not possible. Comments: This study is a randomized, parallel, single-blind clinical trial with a non-pharmacological intervention. The intervention under investigation is gamification for older adults, and the control group receives only usual care. This project was approved by the Research Ethics Committee of Shahroud University of Technology with ethics code IR.SHAHROODUT.REC.1405.007, and its execution site is Yasuj University. Financial support for the project is provided by the Iran National Science Foundation. No placebo, pharmaceutical agent, or invasive intervention is used in this study. Trial registration will be performed before the start of sampling. Also, there is no conflict of interest for the principal investigator and project collaborators.
public Dr. Ayoub Hashemi
Yasouj University, Daneshjoo Street, Yasuj, Kohgiluyeh and Boyer-Ahmad Province, Iran
yasouj Iran (Islamic Republic of) 7591874934 +98 74 3100 3000 a.hashemi@yu.ac.ir Yasouj University scientific Dr.Ayoub Hashemi
Yasouj University, Daneshjoo Street, Yasouj, Kohgiluyeh and Boyer-Ahmad Province, Iran
yasouj Iran (Islamic Republic of) 7591874934 +98 74 3100 3000 a.hashemi@yu.ac.ir Yasouj university Iran (Islamic Republic of) Age 60 years or older. Residence in Yasouj city. Ability to communicate verbally and perform activities of daily living. No severe cognitive impairment (MoCA score ≥ 18). Willingness to participate in the study and signing the informed consent form. 60 years no limit Both Voluntary withdrawal at any stage of the study. Development of an acute illness or exacerbation of chronic diseases during the intervention period. Missing more than 3 consecutive sessions or 5 non-consecutive sessions of the intervention. Lack of cooperation in completing the questionnaires or performing the between-session assignments. Z72.3 Z74.1 R41.81 Lack of physical exercise Need for assistance with personal care Age-related cognitive decline Rehabilitation Rehabilitation Intervention Group: The gamification intervention consists of 8 weeks, 3 sessions per week, with each session lasting 60 to 90 minutes. The sessions are held in groups of 10 to 15 older adults at local health centers in Yasouj. The structure of each session includes the following components: Warm-up and review of weekly assignments: 10 minutes Gamified physical activity: 20 to 30 minutes, including balance, strength, and aerobic exercises with game elements such as team challenges, individual competition, and receiving badges Gamified cognitive training: 20 to 30 minutes, including group mental games such as memory, attention, and problem-solving with challenge cards and scoring Group discussion and self-care: 10 minutes, including exchanging experiences about medication management, nutrition, sleep, and mental health using educational cards Summary and setting individual challenges for the next week: 5 minutes The scoring system is designed based on the Octalysis framework. Each participant receives 140 base points at the beginning of the week. Completing the daily assignment earns 10 points, completing the group assignment earns 10 points, attending the session earns 5 points, active participation earns 5 to 10 points, and winning the group challenge earns 10 bonus points. If the daily assignment is not completed, 20 points are deducted. Progress levels include Beginner from 0 to 200 points, Silver from 201 to 500 points, Gold from 501 to 800 points, and Platinum from 801 points and above. Badges include the First Step badge for completing the first week of the intervention, the Teamwork badge for the highest cooperation with the team, and the Persistence badge for attending all sessions. Between-session assignments include daily walking for at least 30 minutes using a pedometer, performing a simple mental game such as crossword puzzles or Sudoku, and recording medication intake, sleep quality, nutrition, and self-care status in self-care cards. Control group: The control group receives only routine care. This care consists of a general health education session and the provision of a pamphlet on a healthy lifestyle. Additionally, they are provided with a pedometer to track their daily step count; however, no gamification interventions are implemented for them. Primary Outcome Variable 1 - Sedentary Behaviors: Score of sedentary behaviors in older adults measured using the Physical Activity Scale for the Elderly (PASE) and daily step counts recorded by a digital pedometer. Timepoint: Measurement is performed at two time points: before the start of the intervention (pre-test) and immediately after the end of the 8-week intervention (post-test). Method of measurement: Physical Activity Scale for the Elderly and a digital pedometer to record daily step counts. Description of Primary Outcome Variable 2 – Self-care: The self-care ability score of older adults, measured using the Persian version of the Self-Care Ability Scale for the Elderly (SASE). Timepoint: Measurement is performed at two time points: before the start of the intervention (pre-test) and immediately after the end of the 8-week intervention (post-test). Method of measurement: Self-Care Ability Scale for the Elderly, Persian version. Description of Primary Outcome Variable 3 – Cognitive Decline: The cognitive performance score of older adults, measured using the Persian version of the Montreal Cognitive Assessment (MoCA-P). Timepoint: Measurement is performed at two time points: before the start of the intervention (pre-test) and immediately after the end of the 8-week intervention (post-test). Method of measurement: Montreal Cognitive Assessment, Persian version. yasouj university Approved 2026-05-06 Research Ethics Committee of Shahroud University of Technology Research Ethics Committee, Shahroud University of Technology, Hafte Tir Boulevard, Shahroud, Iran semnan Semnan Iran (Islamic Republic of)