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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

Protocol summary

Study aim
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
Design
Participants will be selected using purposive sampling from nursing home residents aged 60 years and older with Mild Cognitive Impairment. They will then be randomly assigned to two groups of 15 participants each.
Settings and conduct
Older adults aged 60 years and above with Mild Cognitive Impairment residing in nursing homes will be recruited. After meeting the inclusion and exclusion criteria and completing the informed consent form and personal information questionnaire, participants will be randomly assigned, using simple randomization, to two groups of 15 participants each. One group will perform (SSE), while the other group will perform (OEP). Both interventions will be conducted for eight weeks, three sessions per week, with each session lasting 60 minutes.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:1)Older adults with Mild Cognitive Impairment (MCI).2)Age 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 participate in the physical assessments and perform physical activity. Exclusion Criteria:1)Absence from the training sessions.2)Presence of visual impairments that cannot be corrected by glasses, contact lenses, or surgery.3)Presence of any neurological disease, orthopedic disorder, or cardiovascular disorder.
Intervention groups
Group 1: Square-Stepping Exercise(SSE) Group 2: Otago Exercise Program(OEP)
Main outcome variables
lower limb strength, static balance, dynamic balance, gait speed, range of motion, functional independence, cognitive performance, quality of life, and fear of falling

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260609069721N1
Registration date: 2026-06-12, 1405/03/22
Registration timing: prospective

Last update: 2026-06-12, 1405/03/22
Update count: 0
Registration date
2026-06-12, 1405/03/22
Registrant information
Name
Reyhane Jalali
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3680 0000
Email address
reyhanejalali7636@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-13, 1405/03/23
Expected recruitment end date
2026-06-15, 1405/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University
Street address
Research Ethics Committee, Third Floor, Central Library Building, University of Isfahan, University Street, Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Approval date
2026-05-04, 1405/02/14
Ethics committee reference number
IR.UI.REC.1405.028

Health conditions studied

1

Description of health condition studied
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
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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.

2

Description
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.

3

Description
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.

4

Description
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.

5

Description
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.

6

Description
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.

7

Description
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).

8

Description
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).

9

Description
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).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Square-Stepping Exercise (SSE), three sessions per week, 60 minutes per session, for eight weeks.
Category
Rehabilitation

2

Description
Intervention Group 2: Otago Exercise Program (OEP), three sessions per week, 60 minutes per session, for eight weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadeghieh Nursing Home
Full name of responsible person
Mohammad Sadegh Katiraei
Street address
Sadeghieh Nursing Home, located at the end of Imam Khomeini Street, Industrial University Square, between Mahmoudabad Street and Aminabad Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8195181115
Phone
+98 31 3380 6550
Email
info@sadeqieh.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Dr.Babak Saffari
Street address
First Floor, Central Library Building, University of Isfahan, University Street, Azadi Square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2171
Email
rokni@sci.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Isfahan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Reyhane Jalali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injuries and Corrective Exercise
Street address
No. 223, Aftab 3 Alley, Aftab Alley, Ordibehesht-e Sharghi Street, Baharestan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8144188305
Phone
+98 31 3680 0000
Fax
Email
reyhanejalali7636@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Reyhane Jalali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injuries and Corrective Exercise
Street address
No. 223, Aftab 3 Alley, Aftab Alley, Ordibehesht-e Sharghi Street, Baharestan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8144188305
Phone
+98 31 3680 0000
Fax
Email
reyhanejalali7636@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Reyhane Jalali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injuries and Corrective Exercise
Street address
No. 223, Aftab 3 Alley, Aftab Alley, Ordibehesht-e Sharghi Street, Baharestan, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8144188305
Phone
+98 31 3680 0000
Fax
Email
reyhanejalali7636@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A subset of the data, such as information related to the primary outcome or similar variables, may be shared.
When the data will become available and for how long
6 months after publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
De-identified data and study documents will not be made publicly available. In case of request, access to the data will only be granted with the approval of the principal investigator and in accordance with ethical guidelines and institutional regulations, while ensuring full confidentiality of participants.
From where data/document is obtainable
reyhanejalali7636@gmail.com
What processes are involved for a request to access data/document
6 months after publication of the results
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