Protocol summary

Study aim
Comparison of the effect of core stability training and dynamic neuromuscular stabilization exercise (DNS) on core area endurance, balance, fear of falling and quality of life in elderly women
Design
The clinical trial has two experimental groups and a control group, with parallel and random groups. The Roll of dice method was used for randomization.
Settings and conduct
The present study is a quasi-experimental research with a pre-test - post-test design. 36 elderly women randomly divided into two experimental and one control groups. Core area endurance, balance, fear of falling and quality of life are measured before and after exercises. This study is performed in Shiraz sanatoriums.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elderly; women; aged 55 to 65 years; Exclusion criteria: Inability to perform exercises, Lack of balance disorders, No history of falls
Intervention groups
The first intervention group includes elderly women who receive central stability exercise intervention. The second intervention group includes elderly women who receive dynamic neuromuscular stabilization (DNS) intervention. The control group included elderly women who did not receive any intervention.
Main outcome variables
Core area endurance, Balance, Fear of falling, Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046035N8
Registration date: 2022-03-29, 1401/01/09
Registration timing: prospective

Last update: 2022-03-29, 1401/01/09
Update count: 0
Registration date
2022-03-29, 1401/01/09
Registrant information
Name
Hossein Shahrokhi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2756
Email address
h.shahrokhi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of core stability training and dynamic neuromuscular stabilization exercise (DNS) on core area endurance, balance, fear of falling and quality of life in elderly women
Public title
The effect of core stability training and dynamic neuromuscular stabilization exercise (DNS) on core area endurance, balance, fear of falling and quality of life in elderly women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender Aged 55 to 65 years
Exclusion criteria:
Inability to perform exercises Lack of balance disorders No history of falls
Age
From 55 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method was used to assign individuals to three groups. In this method, the Roll of a dice method was used to create a random sequence. In this method, the numbers 1 and 2 were considered for the first group, the numbers 3 and 4 for the second group, and the numbers 5 and 6 for the third group. Then, in order not to determine which group the individuals will be assigned to before dividing them into three groups, or in other words, allocation concealment, the central randomization method was used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport sciences research institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2022-01-19, 1400/10/29
Ethics committee reference number
IR.SSRC.REC.1400.123

Health conditions studied

1

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

Primary outcomes

1

Description
Core area endurance
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention
Method of measurement
Trunk flexion and forward and sideways plank tests

2

Description
Balance
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention
Method of measurement
Sharpened Romberg test and Get Up and Go test

3

Description
Fear of falling
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention
Method of measurement
Fall Efficacy Scale

4

Description
Quality of life
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention
Method of measurement
WHO Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Core stability training, for 8 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

2

Description
Intervention group: Dynamic neuromuscular stabilization training, for 8 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

3

Description
Control group: Without any training and just doing normal daily activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafagh University
Full name of responsible person
Elham Moeini
Street address
20th Mordab Ave, Nashtaroud
City
Tonekabon
Province
Qazvin
Postal code
4683165363
Phone
+98 11 5426 6957
Email
eli1400140014001400@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shafagh University
Full name of responsible person
Mohammad Fallahmohamadi
Street address
20th Mordab Ave
City
Nashtarood
Province
Mazandaran
Postal code
4683165363
Phone
+98 11 5426 6957
Email
info@shafagh.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shafagh University
Proportion provided by this source
10
Public or private sector
Private
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
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Hakim Sabzevari University - Tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98514401101
Email
h.shahrokhi@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Hakim Sabzevari University - Tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98514401101
Email
h.shahrokhi@hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Hakim Sabzevari University - Tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98514401101
Email
h.shahrokhi@hsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period one year after printing the results
To whom data/document is available
Data will be available to academic and scientific researchers
Under which criteria data/document could be used
Any kind of functional analysis on the submitted data is allowed
From where data/document is obtainable
by Email: h.shahrokhi@hsu.ac.ir
What processes are involved for a request to access data/document
by Email: h.shahrokhi@hsu.ac.ir and the reason for using the documents
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