Effect of muscle setting exercise before anterior cruciate ligament surgery versus control group on balance and strength of quadriceps and hamstring muscles: a randomized clinical trial
To assess the effect of muscle setting exercise before anterior cruciate ligament surgery versus control group on balance and strength of quadriceps and hamstring muscles
Design
This is a randomized clinical trial, phase II, in which 30 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing anterior cruciate ligament surgery and referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Indication for anterior cruciate ligament surgery,
Exclusion criteria:
History of anterior cruciate ligament surgery
Intervention groups
Intervention group:
Muscle setting exercise of quadriceps and hamstring muscles 45 minutes daily, 3 days a week, for 2 weeks before surgery and routine rehabilitation setting exercise 45 minutes daily, 3 days a week, for 6 weeks after surgery
Control group:
Routine rehabilitation setting exercise 45 minutes daily, 3 days a week, for 6 weeks after surgery
Main outcome variables
Primary outcome:
Balance and strength of quadriceps and hamstring muscles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N388
Registration date:2021-03-14, 1399/12/24
Registration timing:prospective
Last update:2021-03-14, 1399/12/24
Update count:0
Registration date
2021-03-14, 1399/12/24
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of muscle setting exercise before anterior cruciate ligament surgery versus control group on balance and strength of quadriceps and hamstring muscles: a randomized clinical trial
Public title
Effect of muscle setting exercise before anterior cruciate ligament surgery versus control group on balance and strength of quadriceps and hamstring muscles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Indication for anterior cruciate ligament surgery,
Exclusion criteria:
History of anterior cruciate ligament surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We will prepare two sheets of paper, writing on one sheet the name of the intervention and on another sheet the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all two sheets are drawn. The two paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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
Ethics Committee of Hamadan Buali Sina University
Street address
Vice-chancellor for Research and Technology, Hamadan Buali Sina University, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.BASU.REC.1398.014
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament surgery
ICD-10 code
M23.61
ICD-10 code description
Other spontaneous disruption of anterior cruciate ligament of knee
Primary outcomes
1
Description
Balance and strength of quadriceps and hamstring muscles
Timepoint
Before surgery and 6 weeks after that
Method of measurement
Using dynamometer machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Muscle setting exercise of quadriceps and hamstring muscles 45 minutes daily, 3 days a week, for 2 weeks before surgery and routine rehabilitation setting exercise 45 minutes daily, 3 days a week, for 6 weeks after surgery
Category
Treatment - Other
2
Description
Control group: Routine rehabilitation setting exercise 45 minutes daily, 3 days a week, for 6 weeks after surgery
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Mahtab Pirani
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
Pirani.mb60@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Gholam Hosein Majzubi
Street address
Hamadan Buali Sina University, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
info.research@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Mahtab Pirani
Position
Student of Physical Education and Sports Sciences
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Faculty of Sports Sciences, Hamadan Buali Sina University, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
Pirani.mb60@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ali Yalfani
Position
Sports Rehabilitation Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Faculty of Sports Sciences, Hamadan Buali Sina University, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1601
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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