The aim of this study was to evaluate the effect of strengthening hip muscles on the patients' function after unilateral total knee arthroplasty.
Design
Clinical trials with control group, with parallel groups, without blindness, randomized
Settings and conduct
The study will be done in Rasool Akram Hospital and Shafa Yahyaiean Hospital and will be started 2 days after surgery and 3 times a week. There are two intervention and control groups that received both TENS and infrared radiation for 20 minutes, strengthening exercises of knee flexor and extensor muscles and range of motion exercises, and the intervention group received strengthening exercises of hip muscles from the fourth session. ten treatment sessions will be done for All subjects.Patients are asked to do each exercise three times a day and 10 repetitions each time.
Participants/Inclusion and exclusion criteria
inclusion criteria:
unilateral total knee replacement
Indication of bicompartment prothesis
Cemented fixation
There is no problem or another surgery except joint replacement in the lower extremities that is limiting the function
Absence of cognitive impairment
Lack of abnormal blood pressure and uncontrolled diabetes
BMI less than 40
Not having another surgery program during this study
Lack of post-surgery complications including hemarthrosis, infection, fracture, wound impairment
No visual and auiditory impairment
exclusion criteria:
The occurrence of any problem in the implementation of the plan
Lack of patient willingness to continue cooperation
Incidence of deep venous thrombosis
Intervention groups
control group :
Strengthening exercises of knee extensor and flexor muscles and range of motion exercises
intervention group:
exercises of control group and strengthening exercises of hip muscles
Main outcome variables
Pain; range of motion; quality of life; function; strength of the knee and hip muscles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150314021459N6
Registration date:2018-12-26, 1397/10/05
Registration timing:registered_while_recruiting
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Mohammad Akbari
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitation,Iran University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
akbari.mo@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of early hip muscles strengtheing on physical function in patients with unilateral total knee arthroplasty
Public title
Influence of hip strengtheing on function in patients with knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
unilateral total knee replacement
Indication of bicompartment prothesis
Cemented fixation
There is no problem or another surgery except joint replacement in the lower extremities that is limiting the function
Absence of cognitive impairment
Lack of abnormal blood pressure and uncontrolled diabetes
BMI less than 40
Not having another surgery program during this study
Lack of post-surgery complications including hemarthrosis, infection, fracture, wound impairment
No visual and auiditory impairment
Exclusion criteria:
The occurrence of any problem in the implementation of the plan
Lack of patient willingness to continue cooperation
Incidence of deep venous thrombosis
Age
From 50 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule
Procedure :
12 pieces of paper showing A (representative of control group) and 12 pieces showing B (representative of intervention group) are mixed in a box. Every patient picks one of them and that paper will not be put back in the box.
patients don`t know what each letter (A or B) shows.
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 Iran University of Medical Sciences
Street address
Hemmat Highway, between sheykh fazlollah and Chamran Highways, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.IUMS.REC 1396.9511340012
Health conditions studied
1
Description of health condition studied
Exercise therapy after unilateral total knee arthroplasty
ICD-10 code
Z50.1
ICD-10 code description
Therapeutic and remedial exercises
Primary outcomes
1
Description
Function
Timepoint
First and last sessions
Method of measurement
Timed up and go test, Stair climbing test, 6 minute walk test
Secondary outcomes
1
Description
Pain
Timepoint
First and last sessions
Method of measurement
By using visual analogue scale
2
Description
Range of motion
Timepoint
First and last sessions
Method of measurement
By using goniometer
3
Description
Quality of life
Timepoint
First and last sessions
Method of measurement
By using short form 36 questionnaire
4
Description
Hip and knee muscles strength
Timepoint
First and last sessions
Method of measurement
By using dynamometer
Intervention groups
1
Description
Control group: Patients in this group will take TENS and infrared radiation for 20 minutes and after that strengthening exercises of knee extensors and flexors and range of motion exercises.. The start of treatment sessions is two days after surgery and 3 times a week up to ten sessions.
Category
Rehabilitation
2
Description
Intervention group: control group interventions in addition to strengthening exercises of hip muscles
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Ali Amiri
Street address
Mansoori St, Sattar Khan St
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2575
Email
amiri.a@iums.ac.ir
2
Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Kourosh Mansory
Street address
Mujahedin-e-Islam St, Baharestan Square
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 3354 2001
Email
mansori.k@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Hemmat highway, between Chamran and Sheikh Fadlallah highways, Iran University of Medical Sciences, headquarters, 5th floor
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
naserbakht.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Position
Vice chancellor for research
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
kmalakouti@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Madadkaran Al., Shahnazari St., Madar Sq., Mirdamad Blvd.