]>
IRCT20260609069721N1 IRCT 2026-06-12 The University of Isfahan Comparison of the Square Stepping with Otago Exercise on Motor and Cognitive Performance, Quality of Life and Fear of Falling in Older Adults with Mild Cognitive Impairment Comparison of the Effect of Eight Weeks of Square Stepping with Otago Exercise on Motor and Cognitive Performance, Quality of Life and Fear of Falling in Older Adults with Mild Cognitive Impairment 2026-06-13 anticipated 30 Complete https://irct.ir/trial/90706 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After selecting the eligible participants and obtaining informed consent, participants were randomly assigned to the two intervention groups. For randomization, a unique identification code was assigned to each participant, and a random number was generated for each individual using the RAND function in Microsoft Excel. Participants were then ranked according to the generated random numbers and allocated equally to the Square-Stepping Exercise group and the Otago Exercise Program group (15 participants in each group), Blinding description: Outcome assessments were conducted by an assessor who was unaware of the participants' group allocation. To minimize assessment bias, the assessor was blinded to the type of intervention received by the participants (Square-Stepping Exercise or the Otago Exercise Program). In addition, participants were unaware of the main study hypothesis and any potential superiority of one intervention over the other. N/A Comparison of the Effect of Eight Weeks of Square Stepping with Otago Exercise on Motor and Cognitive Performance, Quality of Life and Fear of Falling in Older Adults with Mild Cognitive Impairment. Intervention 1: Intervention Group 1: Square-Stepping Exercise (SSE), three sessions per week, 60 minutes per session, for eight weeks. Intervention 2: Intervention Group 2: Otago Exercise Program (OEP), three sessions per week, 60 minutes per session, for eight weeks. 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 At the time of trial registration, no final decision has been made regarding the sharing of de-identified individual participant data. Any future data sharing will be considered in accordance with ethical guidelines, institutional policies, and participant confidentiality requirements.
public Reyhane Jalali
No. 223, Aftab 3 Alley, Aftab Alley, Ordibehesht-e Sharghi Street, Baharestan, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8144188305 +98 31 3680 0000 reyhanejalali7636@gmail.com The University of Isfahan scientific Reyhane Jalali
No. 223, Aftab 3 Alley, Aftab Alley, Ordibehesht-e Sharghi Street, Baharestan, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8144188305 +98 31 3680 0000 reyhanejalali7636@gmail.com The University of Isfahan Iran (Islamic Republic of) 1- Older adults with mild cognitive impairment, defined as a score between 19 and 26 on the Montreal Cognitive Assessment (MoCA). 2-Aged 60 years and older 3- Not concurrently participating in any other exercise or intervention program 4-Ability to understand instructions and complete the study questionnaires. 5- Ability to attend the physical assessments and participate in the study's physical activity program. 60 years no limit Female Unwillingness to continue participation in the study or attend the training sessions. Presence of visual impairments that cannot be corrected with glasses, contact lenses, or surgery. Presence of any neurological disease (e.g., stroke, Parkinson’s disease), orthopedic disorder (e.g., rheumatoid arthritis, bone fracture), or cardiovascular disorder. Rehabilitation Rehabilitation Intervention Group 1: Square-Stepping Exercise (SSE), three sessions per week, 60 minutes per session, for eight weeks. Intervention Group 2: Otago Exercise Program (OEP), three sessions per week, 60 minutes per session, for eight weeks. Lower limb strength will be assessed using the 30-Second Chair Stand Test. In this test, the participant is asked to repeatedly stand up from and sit down on a standard chair without armrests for 30 seconds. The total number of completed sit-to-stand repetitions performed within 30 seconds will be recorded as the participant's score. Timepoint: Time points of assessment for lower limb strength: Baseline (before intervention) and at the end of the study (after intervention). Method of measurement: Lower limb strength will be assessed using the 30-Second Chair Stand Test. Static balance will be assessed using the Sharpened Romberg Test. In this test, participants will stand barefoot in a tandem position, with the dominant foot placed in front of the other foot and the arms crossed over the chest. The length of time that each participant is able to maintain balance in this position will be recorded as the test score. Timepoint: Time points of assessment for static balance: Baseline (before intervention) and at the end of the study (after intervention). Method of measurement: Static balance will be assessed using the Sharpened Romberg Test. Dynamic balance will be assessed using the Timed Up and Go (TUG) Test. In this test, participants will be instructed to sit on a chair and, upon the command “Go,” stand up, walk a distance of 3 meters in a straight line, turn around a designated marker, walk back to the chair, and sit down again. The time required to complete the test will be recorded in seconds. Timepoint: Time points of assessment for dynamic balance: Baseline (before intervention) and at the end of the study (after intervention). Method of measurement: Dynamic balance will be assessed using the Timed Up and Go (TUG) Test. Walking speed will be assessed using the 10-Meter Walk Test. In this test, participants will be instructed to walk a distance of 10 meters in the shortest possible time. Walking speed will be calculated by dividing the distance traveled (10 meters) by the time taken to complete the test and will be expressed in meters per second (m/s). Timepoint: Time points of assessment for walking speed: Baseline (before intervention) and at the end of the study (after intervention). Method of measurement: Walking speed will be assessed using the 10-Meter Walk Test. The range of motion (ROM) of the hip, knee, and ankle joints will be measured using a goniometer. The primary outcome will be the improvement of joint range of motion toward normal values. Timepoint: Range of motion will be measured at baseline and at the end of the study. Method of measurement: The range of motion (ROM) of the hip, knee, and ankle joints will be measured using a goniometer. Functional independence will be assessed using the Lawton and Brody IADL Scale. The maximum obtainable score is 8. Timepoint: Functional independence will be assessed at baseline and at the end of the study. Method of measurement: Functional independence will be assessed using the Lawton and Brody IADL Scale. Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). In the MoCA, a score of 26 or higher is considered normal, while in the MMSE, a score of 24 or higher is considered normal. Timepoint: Cognitive function will be assessed at baseline and at the end of the study. Method of measurement: Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Quality of life will be assessed using the Older People's Quality of Life Questionnaire (OPQOL-35). Higher scores indicate better quality of life. Timepoint: Quality of life will be measured at baseline and at the end of the study. Method of measurement: Quality of life will be assessed using the Older People's Quality of Life Questionnaire (OPQOL-35). Fear of falling will be assessed using the Falls Efficacy Scale–International (FES-I). A higher score indicates a greater fear of falling. Timepoint: Fear of falling will be measured at baseline and at the end of the study. Method of measurement: Fear of falling will be assessed using the Falls Efficacy Scale–International (FES-I). The University of Isfahan Approved 2026-05-04 Ethics committee of Isfahan University Research Ethics Committee, Third Floor, Central Library Building, University of Isfahan, University Street, Azadi Square, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)