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Effects of Sling Exercise Training on improve the Strength of Muscles , Range of Motion, and Functional Outcomes following Total knee Arthroplasty

Protocol summary

Study aim
The present study aims are intervention of a new active sling exercise therapy on enhancement of strength of muscles, and knee range of motion, and functional outcomes following total knee arthroplasty patients.
Design
Randomized, non-blinded clinical trial on 60 female knee arthroplasty patients with the age range of 50 to 70 years who are eligible to enter the study will be selected in two intervention and one control groups.
Settings and conduct
60 female patients undergoing total knee arthroplasty under the supervision of the same specialist doctor referring to Arian Physiotherapy Center located in Isfahan, will be selected and will be placed in one of the two intervention groups or the control group. At the beginning of the research, the WOMAC quality of life questionnaire, the strength of the examined muscles (Quadriceps and Hamstrings) and the range of motion of the knee joint will be measured. Then, the training protocols will be applied for eight weeks and after completion, the initial measurements will be made again.
Participants/Inclusion and exclusion criteria
entry conditions: Having a female gender with an age range of 50-70 years, performing a total knee arthroplasty in the last 2 months by specific doctor; Conditions of non-entry: suffering from acute cardiovascular problems or a specific disease that prevents sports activities.
Intervention groups
The first intervention group performed 3 sessions per week for 8 weeks, performed sling exercises therapy after the physiotherapy, the second intervention group performed the rehabilitation exercise protocol for total knee arthroplasty after the physiotherapy, and the control group without exercise intervention after the physiotherapy .
Main outcome variables
Strength of Quadriceps, Hamstrings muscles, Knee Range of motion(Flexion and Extension), Functional outcomes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221226056934N1
Registration date: 2023-02-25, 1401/12/06
Registration timing: registered_while_recruiting

Last update: 2023-02-25, 1401/12/06
Update count: 0
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Nooshin Rajaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4532 2194
Email address
noushin.rajaeian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-24, 1401/12/05
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Sling Exercise Training on improve the Strength of Muscles , Range of Motion, and Functional Outcomes following Total knee Arthroplasty
Public title
Effects of Sling Exercise Training on improve the Strength of Muscles , Range of Motion, and Functional Outcomes following Total knee Arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Total Knee Arthroplasty since 2 months
Exclusion criteria:
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling: The people of the society will be numbered first and after the lottery will be randomly placed in three groups (two intervention and one control).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sport Science Research Institute Of Iran
Street address
No.3, 5th St., Mir Emad St., Motahari Ave
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.SSRC.REC.1401.110

Health conditions studied

1

Description of health condition studied
Rehabilitation of Total Knee Arthroplasty
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Strength of Quadriceps and Hamstring muscles
Timepoint
At the beginning of the study before the intervention and after 8 weeks
Method of measurement
J-Tech American dynamometer

2

Description
Knee joint flexion and extension range of motion
Timepoint
At the beginning of the study before the intervention and after 8 weeks
Method of measurement
Goniometer

3

Description
Knee Functionals Outcomes
Timepoint
At the beginning of the study before the intervention and after 8 weeks
Method of measurement
WOMAC quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Three sessions a week for 8 weeks of Sling exercises
Category
Rehabilitation

2

Description
Intervention group 2: Rehabilitation protocol after Total knee Arthroplasty
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Arian Physiotherapy and Rehabilitation Clinic
Full name of responsible person
Mojtaba Ghazi Isfahani
Street address
No. 35., 1st West St., Parvin Etesami Blvd
City
Shahinshahr
Province
Isfehan
Postal code
8314816531
Phone
+98 31 4527 8156
Email
noushin.rajaeian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghiani
Street address
University Blvd., Arghwanieh St., Jey Ave.
City
Khorasgan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nooshin Rajaeian
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Sport science(sport injury and corrective exercise therapy)
Street address
No. 46, East 13th Ave., Atar Blvd
City
Shahinshahr
Province
Isfehan
Postal code
8318615946
Phone
+98 31 4532 2194
Fax
Email
noushin.rajaeian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nooshin Rajaeian
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Sport science(sport injury and corrective exercise therapy)
Street address
No. 46, East 13th Ave., Atar Blvd
City
Shahinshahr
Province
Isfehan
Postal code
8318615946
Phone
+98 31 4532 2194
Fax
Email
noushin.rajaeian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nooshin Rajaeian
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Sport science(sport injury and corrective exercise therapy)
Street address
No. 46, East 13th Ave., Atar Blvd
City
Shahinshahr
Province
Isfehan
Postal code
8318615946
Phone
+98 31 4532 2194
Fax
Email
noushin.rajaeian@gmail.com

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data are released after de-identification of individuals in the form of information on main outcomes.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
All researchers, lecturers and students of medical sciences can receive the printed article from the relevant journal
Under which criteria data/document could be used
Non-identifiable data will be made available to health science researchers for study.
From where data/document is obtainable
Send email to Noushin Rajaeian . noushin.rajaeian@gmail.com
What processes are involved for a request to access data/document
After sending the documents by the applicant researcher via email; Data will be sent around two weeks later.
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