The aim of the study is to add in the evidence of physical therapy protocols after the surgical procedure of Total Hip Arthroplasty.
Design
Randomized controlled trial, single-centered, concealed, two arm parallel group of 82 patients, with blinded outcome assessment
Settings and conduct
Settings- Mayo Hospital Lahore (Orthopedics and Physiotherapy Department )
Blinded outcome assessor
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Age 30 to 60 years,
Total hip arthroplasty,
1 to 16 weeks after THA,
Able to understand instructions,
Willing to come for all follow-ups,
Exclusion Criteria
Tumor / cancer,
Total knee replacement,
Revision arthroplasty surgery,
Any underlying terminal disease,
Suspicion of infection following joint replacement,
Intervention groups
Group A will receive Functional Exercise Protocol
Group B will receive Conventional Exercises Protocol
Main outcome variables
Pain, stiffness, physical functioning,
Health related quality of life,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220628055308N1
Registration date:2022-10-02, 1401/07/10
Registration timing:retrospective
Last update:2022-10-02, 1401/07/10
Update count:0
Registration date
2022-10-02, 1401/07/10
Registrant information
Name
Dr. Samawiya Farooq
Name of organization / entity
King Edward Medical University, Lahore, Pakistan
Country
Pakistan
Phone
+92 334 5444098
Email address
samawiyafarooq@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-28, 1401/02/08
Expected recruitment end date
2022-08-31, 1401/06/09
Actual recruitment start date
2022-04-28, 1401/02/08
Actual recruitment end date
2022-08-24, 1401/06/02
Trial completion date
2022-08-26, 1401/06/04
Scientific title
Comparison of the Effect Of Physiotherapy-Led Functional Exercise Regime vs. Conventional Therapy on Functional Outcomes After Total Hip Arthroplasty
Public title
Functional Outcomes After Total Hip Arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 60 years
Total hip arthroplasty
1 to 16 weeks after THA
Able to understand instructions
Willing to come for all follow-ups
Exclusion criteria:
Tumor / cancer
Total knee replacement
Revision arthroplasty surgery
Any underlying terminal disease
Suspicion of infection following joint replacement
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Actual sample size reached:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized Control Trial
Computer generated table of random numbers
The sample was simply randomized into two equal groups (1:1) by MS Excel. The patients were individually assigned group as per the randomization table generated. The randomization sequence was built by using a "Rand" function in MS Excel on the sample of 82 patients with equal distribution of 41 sample among the two groups.
The "Rand" function can be used to generate random numbers. It will return a random number between 0 and 1. The syntax for the RAND function in Microsoft Excel is: RAND( ).
In 1st column of MS Excel spreadsheet, patient numbers were written i.e. 82
In the 2nd column, groups were written. In this study either it's a functional exercise/ group A or a conventional therapy group/ group B. The first 41 samples as functional exercise / group A and next 41 as conventional therapy group/ group B.
In 3rd column, Randomization formula was added which is between 0-1 by Inserting a function called "Rand" in the first row of 3rd column. MS Excel has added a random number to the cell. The random number was then added in the entire column by dragging though the cells.
Column 2 and column 3 were filtered in order to randomize column 2.
After this column 3 was filtered in ascending order from the options of top row header to randomize it. All the content in column 2 were randomized.
Likewise, all the patient numbers were randomized to either functional exercise/ group A or a conventional therapy group/ group B.
The randomization table was generated by the other person and the group allotment of the participant was done by the other on the basis of concealed allocation.
Allocation Concealment was carried out by sequentially numbered, opaque, sealed envelope (SNOSE) technique in which the randomization group were written on a paper and kept in an opaque sealed envelope. The envelope was labeled with a serial number. The investigator opens the sealed envelope once the patient has consented to participate and then assigns the treatment group accordingly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
NA
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board, KEMU, Lahore
Street address
Neelagumbad, Anarkali, Lahore Pakistan
City
Lahore
Postal code
54000
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
300/RC/KEMU/2022 (12-02-2022)
Health conditions studied
1
Description of health condition studied
Total Hip Arthroplasty
ICD-10 code
Z96.64
ICD-10 code description
Presence of artificial hip joint
Primary outcomes
1
Description
Pain
Timepoint
Before Intervention and 6 Weeks After Intervention
Method of measurement
VAS & WOMAC pain score
2
Description
Stiffness
Timepoint
Before Intervention and 6 Weeks After Intervention
Method of measurement
WOMAC Stiffness score
3
Description
Physical Functioning
Timepoint
Before Intervention and 6 Weeks After Intervention
Method of measurement
WOMAC Physical Functioning score
4
Description
Functional Outcomes
Timepoint
Before Intervention and 6 Weeks After Intervention
Method of measurement
WOMAC scores
5
Description
Health Related Quality of Life
Timepoint
Before Intervention and 6 Weeks After Intervention
Method of measurement
SF-12 Scores
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Functional Exercise (Those 41 participants randomized to the intervention group will receive functional exercise under the supervision of the physiotherapist. Each session will be of approximately 35 minutes in length with 10 repetitions for a given exercises. Patients will attend the session twice weekly for 6 weeks, and will be given same exercises as a home exercise program. The functional exercise program in this study will be based on the following exercise plan: Sit to stand, Toe raises, Knee raises, Side and back leg raises, Partial knee bends, Single knee bends, One legged standing balance and advanced one legged standing balance, Pelvic raising and lowering.)
Category
Rehabilitation
2
Description
Control group: Conventional Therapy Group (Those randomized to the Group B will receive the conventional therapy protocol under the supervision of the physiotherapist. Each session will be of 35 minutes in length with 10 repetitions for a given exercises. Patients will attend the session twice weekly for 6 weeks and will be given same exercises as a home exercise plan. This will include the following exercise plan: Foot and ankle pumps, Static quadriceps contractions, Static gluteal contractions, Active hip flexion, Active hip extension, Active hip abduction, Hip external rotations and Hamstring Curls.)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mayo Hospital Lahore, Pakistan
Full name of responsible person
Dr. Samawiya Farooq
Street address
Hospital Rd, Anarkali Bazaar Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 334 5444098
Email
samawiyafarooq@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
King Edward Medical University, KEMU, Lahore, Pakistan
Full name of responsible person
Dr. Samawiya Farooq
Street address
Neelagumbad Anarkali, Lahore Pakistan
City
Lahore
Postal code
56000
Phone
+92 334 5444098
Email
samawiyafarooq@gmail.com
Grant name
No Grant Provided by the Institute
Grant code / Reference number
No Grant Provided by the Institute
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
King Edward Medical University, KEMU, Lahore, Pakistan
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
King Edward Medical University, KEMU, Lahore, Pakistan
Full name of responsible person
Dr. Samawiya Farooq
Position
Post Graduate Resident- Trainee - M.Phil. Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House Number 302, Opposite JCO Club, R.A.Bazaar, Rawalpindi Cantt
City
Lahore
Province
Punjab
Postal code
46000
Phone
+92 334 5444098
Email
samawiyafarooq@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
King Edward Medical University, KEMU, Lahore, Pakistan
Full name of responsible person
Dr. Samawiya Farooq
Position
Post Graduate Resident - Trainee - M.Phil. Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House Number 302, Opposite JCO Club, R.A.Bazaar, Rawalpindi Cantt
City
Lahore
Province
Punjab
Postal code
46000
Phone
+92 334 5444098
Email
samawiyafarooq@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
King Edward Medical University, KEMU, Lahore, Pakistan
Full name of responsible person
Dr. Samawiya Farooq
Position
Post Graduate Resident - Trainee - M.Phil. Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House Number 302, Opposite JCO Club, R.A.Bazaar, Rawalpindi Cantt
City
Lahore
Province
Punjab
Postal code
46000
Phone
+92 334 5444098
Fax
Email
samawiyafarooq@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information"
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Comparison of the Effect Of Physiotherapy-Led Functional Exercise Regime vs. Conventional Therapy on Functional Outcomes After Total Hip Arthroplasty
When the data will become available and for how long
Data will be available after publication of the study.
To whom data/document is available
Data will be available after publication of the study to Clinical researchers and physiotherapists.
Under which criteria data/document could be used
It can be used to further research on the topic.
From where data/document is obtainable
Contact with the corresponding author will be required.
What processes are involved for a request to access data/document
Process can be done through email and can take few days to respond.