Protocol summary

Study aim
Determining the effect of eight weeks of air balance exercises on the variables of posture control, balance, muscle strength of the lower limbs and proprioception of the knee and ankle joints in elderly women with knee osteoarthritis.
Design
Clinical trial with control group, with parallel group, single blinded, randomized
Settings and conduct
The tests will be carried out by the specialists at the Sport Rehabilitation Laboratory, and then interventions and exercises will take place in the gym. And participants will be randomly assigned to intervention and control groups based on allocation concealment using the SNOSE method. This study will be conducted in a blind way so that the outcome assessors will not know about the allocation of the study groups and the reason for their presence in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria included elderly women with knee osteoarthritis, not having any history of knee, no injection of intra-articular steroid in the last six months, having pain in the last three months, and non-entry criteria: In regular exercise activities during the research, cardio-respiratory disorders and neurological diseases, History of fracture or surgery of lower limb joints.
Intervention groups
The intervention group will be received body balance exercises that include breathing, stretching, balance and strength exercises for 8 weeks and 3 sessions of one-hour each week. To do the exercises, tools will be used that help the mobility of soft tissue. Control group without intervention
Main outcome variables
posture control, balance, muscle strength and proprioception of knee joint

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230101057015N1
Registration date: 2023-04-15, 1402/01/26
Registration timing: retrospective

Last update: 2023-04-15, 1402/01/26
Update count: 0
Registration date
2023-04-15, 1402/01/26
Registrant information
Name
Parvin Safarpour
Name of organization / entity
The University of Bu Ali Sina
Country
Iran (Islamic Republic of)
Phone
+98 24 3376 1298
Email address
p.safarpour@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-31, 1402/01/11
Expected recruitment end date
2023-04-10, 1402/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight- weeks of body balance exercises on posture control, balance, lower limb muscle strength and proprioception of knee and ankle joints in elderly women with knee osteoarthritis
Public title
The effect of body balance exercises on knee osteoarthritis of elderly women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly women with knee osteoarthritis Not having any history of knee No injection of intra-articular steroid in the last six months Having pain in the last three months
Exclusion criteria:
Participate in regular exercises activities Cardio-respiratory disorders and neurological diseases History of fracture or surgery of lower limb joints
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on the Random Number Generator software version 1.1 and uses the SNOSE method to assign double groups based on allocation concealment. The randomization of subjects was done in two stages. First, each of the subjects chooses a number between 1-30 using a lottery, then fifteen random numbers are selected between the numbers 1-30 using the Random number generator software, and according to the generated numbers, the chosen numbers of subjects are divided into two groups. Random Number Generator is a simple software for generating random numbers between two specified numbers. To use this software, it is enough to determine the smallest and largest number as well as the wanted number of random numbers and click on the Generate integer button to generate random numbers corresponding to the number and in the specified interval. The software can be downloaded from the following site: http://fa.softoware.org/apps/get-random-number-generator-66296-for-windows.html. To allocation concealment, the closed-sequence envelope method with random allocation (SNOSE) will be used. An accident is recorded on a card and the cards are placed inside the named cleaners in order. In order to maintain random randomness, the numbering on the external surface is done in the same way. Finally, the lids of the letter envelopes are pasted and placed inside the boxes, respectively. At the beginning of the registration of the participants, according to the order of the participants and the conditions of the study, one of them is a special test book or letter.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the study, the outcome valuators (laboratory technicians) will be asked to take the desired tests from the participants. These people will be unaware of the purpose of the research, the allocation of study group, and the reason for their presence in the laboratory, and they only evaluate the variables and record their observations.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bu Ali Sina University
Street address
Bu Ali Sina University, Abu Talib St, Modares Qods, Hamadan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.BASU.REC.1401.022

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified

Primary outcomes

1

Description
posture control
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Time Up & Go test

2

Description
Balance
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Functional reach test

3

Description
Lower limb muscle strength
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Dynamometer

4

Description
proprioception of knee and ankle joints
Timepoint
Before the intervention begins, one day after the end of the intervention
Method of measurement
Photography and reconstruction and evaluation of error rate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Body balance exercises will be for 8 weeks and 3 sessions of one-hour each week. The body balance protocol includes breathing, stretching, balance and strength exercises.To do the exercises, tools that help the mobility of soft tissue will be used.
Category
Rehabilitation

2

Description
Control group: No Intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
General Welfare Department
Full name of responsible person
Syed Razagh Manafi
Street address
Fadaeiyan Islam st, Besat st, zanjan
City
Zanjan
Province
Zanjan
Postal code
4514664415
Phone
+98 24 3354 2001
Email
info@zanjan.behzisti.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzane Saki
Street address
Bu Ali Sina University, Abu Taleb St, Modares Qods
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
F.sport2008@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali Sina 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
Bu Ali Sina University
Full name of responsible person
Parvin Safarpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Talib St, Modares Qods, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
p.safarpour@phe.basu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Parvin Safarpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports Rehabilitation
Street address
Bu Ali Sina University, Abu Talib St, Modares Qods, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
p.safarpour@phe.basu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Parvin Safarpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports Rehabilitation
Street address
Bu Ali Sina University, Abu Talib St, Modares Qods, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
p.safarpour@phe.basu.ac.ir

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
Undecided - It is not yet known if there will be 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
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