Protocol summary

Study aim
Determining the effect of locomotor and aerobic exercise on balance, fear of falling, and lower limb strength in elderly women with Locomotive syndrome
Design
The clinical trial will have two experimental groups and a control group. It will be a single-blind, randomized trial on 45 elderly women with Locomotive syndrome.
Settings and conduct
The (Locomotor Exercises) group will perform locomotor exercises for 8 weeks (three sessions per week), including: standing on one leg, squats, heel raises, and forward lunges. The (Locomotor and Aerobic Exercises) group: In addition to locomotor exercises, this group will perform aerobic exercises for 30 minutes. The control group will not receive any intervention. This trial will take place in a gym in Arak.
Participants/Inclusion and exclusion criteria
Elderly women withLocomotive syndrome, 60 years and older Having individual independence in performing personal and health matters No history of surgery in the lower extremities within the past 2 years No history of degenerative joint diseases
Intervention groups
Experimental group 1. Locomotor and aerobic exercises. Experimental group 2. Locomotor exercises. Group 3. Control
Main outcome variables
Locomotor and aerobic exercise training have an effect on balance, fear of falling, and lower limb strength in elderly women with Locomotive syndrome.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230619058528N2
Registration date: 2025-04-10, 1404/01/21
Registration timing: registered_while_recruiting

Last update: 2025-04-10, 1404/01/21
Update count: 0
Registration date
2025-04-10, 1404/01/21
Registrant information
Name
Zahra Geramipour
Name of organization / entity
The univesity of arak
Country
Iran (Islamic Republic of)
Phone
+98 86 3403 9071
Email address
zahragerami938@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-05, 1404/01/16
Expected recruitment end date
2025-06-06, 1404/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of locomotor training and aerobic exercise on balance, fear of falling, and lower limb strength in elderly women locomotive syndrome
Public title
The effect of locomotor training and aerobic exercise on elderly people with locomotive syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly women with Locomotor syndrome, 60 years and older Having individual independence in personal and health matters No history of lower limb surgery within the past 2 years. No history of degenerative joint diseases
Exclusion criteria:
Inability to perform daily activities and health care History of fractures and surgery in the lower extremities within the last 2 years Elderly people with MS or Parkinson's disease Absence of more than 3 training sessions
Age
From 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The research population will consist of 45 women aged 60 and above with Locomotor syndrome. The number of samples was obtained using G-power software for each of the three groups of 45 people (locomotor exercises combined with aerobic exercises (15 people), locomotor exercises (15 people), and control (15 people)). The groups will be selected by simple random selection.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the division into control and experimental groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University
Street address
Arak University, Karbala Boulevard, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Approval date
2025-03-12, 1403/12/22
Ethics committee reference number
IR.ARAKU.REC.1403.092

Health conditions studied

1

Description of health condition studied
Locomotive syndrome
ICD-10 code
G12.29
ICD-10 code description
Other motor neuron disease

Primary outcomes

1

Description
Dynamic balance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Time to get up and go test

2

Description
Static balance
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Four-Step Balance Test (FsBT)

3

Description
Fear of falling
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
Fear of Falling Questionnaire (FES-I)

4

Description
Lower limb strength
Timepoint
At the beginning of the study and after 8 weeks of intervention
Method of measurement
30-second sit-to-stand test (30sCST)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Locomotor Exercises Combined with Aerobic ExercisesThe locomotor exercises include four types of movements:1. Single-leg stance: This exercise is performed for one minute. If the elderly participants feel unsteady, they can hold onto a chair for support.2. Squats: Performed by bending the knees to a 90-degree angle while holding onto a chair for support. This exercise is done in three sets of six repetitions.3. Heel raises: Executed in three sets of ten repetitions, with a four-count lift and a four-count lower.4. Forward lunges: Taking a step forward as far as possible while maintaining an upright posture. This exercise is performed in three sets of five repetitions.Aerobic exercises for the elderly include activities with low to moderate intensity (40–70% of maximum heart rate) to improve cardiorespiratory endurance, strengthen muscles, and maintain joint flexibility. This section includes:5 minutes of warm-up20 minutes of brisk walking5 minutes of recoveryThese exercises will be conducted for 8 weeks, three sessions per week, with 15 participants.
Category
Prevention

2

Description
Intervention Group 2: (Locomotor Exercises)These exercises include four types of movements:1. Single-leg stance: This exercise is performed for one minute. If the elderly participants feel unsteady, they can hold onto a chair for support.2. Squats: Performed by bending the knees to a 90-degree angle while holding onto a chair for support. This exercise is done in three sets of six repetitions.3. Heel raises: This exercise is performed in three sets of ten repetitions with a four-count lift and a four-count lower.4. Forward lunges: Taking a step forward as far as possible while maintaining an upright posture. This exercise is performed in three sets of five repetitions.These exercises will be conducted for 8 weeks, three sessions per week, and with 15 participants.
Category
Prevention

3

Description
Control Group:This group will include 15 participants who will not receive any intervention for 8 weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hygia Corrective Exercise Center
Full name of responsible person
فرید ثاقبی
Street address
Hygia Corrective Exercise Center, Golha Alley, Abbas Abad Street, Arak
City
Arak
Province
Markazi
Postal code
3819655357
Phone
+98 86 3402 2840
Email
zahragerami938@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University
Full name of responsible person
Mohammad Ali Badaghifard
Street address
Karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
3848177504
Phone
+98 902 432 6286
Email
m_bodaghifard@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University
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
Arak University
Full name of responsible person
Shahnaz Shahrjerdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 902 432 6286
Email
shahjerdi_shahnaz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
دانشگاه اراک
Full name of responsible person
Shahnaz Shahrjerdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 902 432 6286
Email
shahjerdi_shahnaz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Shahnaz Shahrjerdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Karbala Boulevard, Basij Square, Sardasht, Arak University, Arak
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 902 432 6286
Email
shahjerdi_shahnaz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
All data will be available after the research is published.
When the data will become available and for how long
Since 1404
To whom data/document is available
Everyone from university researchers to professors can receive this research.
Under which criteria data/document could be used
A person who intends to study this research can send a message to the researcher via email. The person can also use the information in the article.
From where data/document is obtainable
First, email shahrjerdi.shahnaz@gmail.com, then call the following number: 09161520974, and finally, you can visit the Arak University Library.
What processes are involved for a request to access data/document
The applicant can receive the documents after sending an email to the researcher and receiving confirmation from the researcher.
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