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IRCT20260923071168N1 IRCT 2026-10-07 Tehran University of Medical Sciences The Effect of a Pedometer App and a Virtual Support Group on the Physical Activity among Community-Dwelling Older Adults with Low Physical Activity Determining the Effectiveness of a Combined Pedometer App and Virtual Support Group Intervention on Physical Activity Level and Physical Function among Community-Dwelling Older Adults with Low Physical Activity in Tehran 2026-12-01 anticipated 60 Pending https://irct.ir/trial/93581 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be allocated to the intervention and control groups using simple randomization with a 1:1 allocation ratio. The unit of randomization will be the individual participant, and individual randomization will be used; block, cluster, and stratified randomization will not be used. After identification of all eligible participants and obtaining written informed consent, a final list of participants will be prepared and each participant will be assigned a unique identification code. The participant codes will then be entered into SPSS statistical software, version 27, and using simple randomization, 30 codes will be randomly selected for the intervention group, while the remaining 30 codes will be allocated to the control group. The random allocation sequence will be generated and implemented by a person independent of the researcher and outcome assessors. The researcher and outcome assessors will not be involved in generating the random sequence or assigning participants to the study groups. Group allocation will be performed after eligibility has been confirmed and written informed consent has been obtained. Thus, group allocation will not be predetermined by the researcher and will be performed by an independent person, Blinding description: This study will be single-blinded. The outcome assessors and data collectors at both the pre-test and post-test stages will be blinded to the participants’ group allocation. The participants and the intervention researcher will be aware of the group allocation. N/A Lack of physical exercise. Intervention 1: Intervention group: Participants in the intervention group will receive a 12-week combined intervention consisting of a pedometer application and virtual support. At the beginning of the intervention, the Google Fit pedometer application will be installed on participants’ smartphones, and they will receive training on how to use the application. An individualized daily step goal will be set for each participant according to their baseline physical activity level and individual circumstances. Participants will be asked to monitor and record their daily step counts. In addition, a virtual support group will be established for the intervention participants. Throughout the 12-week intervention, education related to increasing physical activity, motivational messages, social support, and strategies for overcoming barriers to physical activity will be provided through the virtual group. Participants’ progress will be regularly monitored, and individual and group feedback will be provided regarding their progress and achievement of the established goals. Intervention 2: Control group: Participants in the control group will receive usual care and will not receive any specific intervention aimed at increasing physical activity during the 12-week study period. To minimize intervention contamination, the Google Fit pedometer application will also be installed on the smartphones of control-group participants; however, it will remain inactive, with no step goal-setting, feedback, or motivational features enabled. In addition, control-group participants will be placed in a separate virtual group used only for general study-related information and coordination of assessments. No educational, motivational, or intervention-related supportive content will be provided through this group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Vahab Abbaszadeh
No. 288, Mehr Street., Mehrshahr., Birjand
Birjand Iran (Islamic Republic of) 1416753955 +98 56 3237 7490 v-abbaszadeh@razi.tums.ac.ir Tehran University of Medical Sciences scientific Amir Ahmadi
No. 1, Safi Ali Shah St., Pich-e Shemiran., Enqelab Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 Amirahmadi2066@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 60 years or older and residence in Tehran Low level of physical activity (physically inactive) based on the International Physical Activity Questionnaire (IPAQ) Ability to walk independently Having a smartphone capable of installing the pedometer application and having access to the Internet No evidence of cognitive impairment based on initial screening using the Abbreviated Mental Test Score (AMTS) Willingness to participate in the study and provision of written informed consent 60 years no limit Both Having severe acute or chronic diseases that prevent participation in physical activity History of major fracture or major surgery within the past 6 months Suspected cognitive impairment based on an AMTS score of less than 6 Concurrent participation in other interventional studies related to physical activity Z72.3 Lack of physical exercise Lifestyle N/A Intervention group: Participants in the intervention group will receive a 12-week combined intervention consisting of a pedometer application and virtual support. At the beginning of the intervention, the Google Fit pedometer application will be installed on participants’ smartphones, and they will receive training on how to use the application. An individualized daily step goal will be set for each participant according to their baseline physical activity level and individual circumstances. Participants will be asked to monitor and record their daily step counts. In addition, a virtual support group will be established for the intervention participants. Throughout the 12-week intervention, education related to increasing physical activity, motivational messages, social support, and strategies for overcoming barriers to physical activity will be provided through the virtual group. Participants’ progress will be regularly monitored, and individual and group feedback will be provided regarding their progress and achievement of the established goals. Control group: Participants in the control group will receive usual care and will not receive any specific intervention aimed at increasing physical activity during the 12-week study period. To minimize intervention contamination, the Google Fit pedometer application will also be installed on the smartphones of control-group participants; however, it will remain inactive, with no step goal-setting, feedback, or motivational features enabled. In addition, control-group participants will be placed in a separate virtual group used only for general study-related information and coordination of assessments. No educational, motivational, or intervention-related supportive content will be provided through this group. Participants’ physical activity level assessed using the International Physical Activity Questionnaire and reported as MET-minutes/week. Timepoint: Measured at baseline, before initiation of the intervention (week 0), and after completion of the 12-week intervention (week 12). Method of measurement: Measured using the International Physical Activity Questionnaire (IPAQ), long form, which assesses physical activity during the previous 7 days, including vigorous-intensity, moderate-intensity activities, and walking. Mean daily step count over 7 days. Timepoint: Measured at baseline, before initiation of the intervention (week 0), and after completion of the 12-week intervention (week 12). Method of measurement: Measured using the Google Fit application and the smartphone’s built-in step-counting sensor, based on daily step counts recorded over 7 days. Participants’ physical function based on the Short Physical Performance Battery (SPPB) score, including balance, gait speed, and the five-times sit-to-stand test. Timepoint: Measured at baseline, before initiation of the intervention (week 0), and after completion of the 12-week intervention (week 12). Method of measurement: Measured using the Short Physical Performance Battery (SPPB), comprising three components: balance, gait speed, and the five-times sit-to-stand test. Physical function is reported based on the total SPPB score. Health-related quality of life score. Timepoint: Measured at baseline, before initiation of the intervention (week 0), and after completion of the 12-week intervention (week 12). Method of measurement: Measured using the 12-Item Short Form (SF-12). Systolic and diastolic blood pressure levels. Timepoint: Measured at baseline, before initiation of the intervention (week 0), and after completion of the 12-week intervention (week 12). Method of measurement: Measured using a calibrated digital upper-arm blood pressure monitor after seated rest and according to a standardized blood pressure measurement protocol. Results are reported in millimeters of mercury (mmHg). Depression score. Timepoint: Measured at baseline, before initiation of the intervention (week 0), and after completion of the 12-week intervention (week 12). Method of measurement: با استفاده از مقیاس ۱۵ سؤالی افسردگی سالمندان (GDS-15؛ Geriatric Depression Scale) برای غربالگری علائم افسردگی در سالمندان. نمره کل مقیاس برای ارزیابی علائم افسردگی استفاده خواهد شد. Tehran University of Medical Sciences Approved 2026-09-21 Ethics Committee of Tehran University of Medical Sciences – School of Nursing and Midwifery and Scho No. 288, Mehr Street, Mehrshahr, Birjand, South Khorasan Province, Iran Tehran Tehran Iran (Islamic Republic of)