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EFFECTS OF KNEE STRENGTHENING EXERCISES WITH AND WITHOUT HIP STRENGTHENING EXERCISES IN WOMEN WITH KNEE OSTEOARTHRITIS: RANDOMIZED CONTROLLED TRAIL

Protocol summary

Study aim
The aim of study was to determine combine effects of hip strengthening exercises with knee strengthening exercises on knee pain, function and activities of daily livings and quality of life in women with knee osteoarthritis
Design
A single-blind, randomized controlled trial
Settings and conduct
Physical therapy department of WAPDA Teaching Hospital Complex Lahore, Lahore
Participants/Inclusion and exclusion criteria
The inclusion criteria; Age 40-70 year, Female only, Unilateral knee OA, Diagnosed patients of knee OA by orthopedic, Grade II to III by Kellgren– Lawrence scale and No pervious surgical/ steroid injection history with in last 6month. The following were the exclusion criteria; Bony abnormalities that affected knee, Plan of surgical procedure with in the time frame of study, Have history of injury that may cause OA, Systemic inflammatory and medical disease that have prevent physical activity
Intervention groups
A resistance exercises program included Hip exercise with Hnee exercise (Hip flexors, Hip extensor, Hip abductor/adductor, Hip external and Internal rotators) and Knee strengthening (Knee flexors, Knee extensor). The subjects in CG were underwent a resistance exercises program included only Knee exercises (Knee flexors, Knee extensor, Leg press, Heel press and Calf hold
Main outcome variables
Pain, Function and Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230124057196N1
Registration date: 2023-05-23, 1402/03/02
Registration timing: retrospective

Last update: 2023-05-23, 1402/03/02
Update count: 0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
mariam umer hayat
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 321 4437350
Email address
mariamumerhayat@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-25, 1401/11/05
Expected recruitment end date
2023-02-02, 1401/11/13
Actual recruitment start date
2023-01-25, 1401/11/05
Actual recruitment end date
2023-01-25, 1401/11/05
Trial completion date
empty
Scientific title
EFFECTS OF KNEE STRENGTHENING EXERCISES WITH AND WITHOUT HIP STRENGTHENING EXERCISES IN WOMEN WITH KNEE OSTEOARTHRITIS: RANDOMIZED CONTROLLED TRAIL
Public title
EFFECTS OF KNEE STRENGTHENING EXERCISES WITH AND WITHOUT HIP STRENGTHENING EXERCISES IN WOMEN WITH KNEE OSTEOARTHRITIS: RANDOMIZED CONTROLLED TRAIL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-70 year, , and Female only, Unilateral knee OA, Diagnosed patients of knee OA by orthopedic Drade II to III by Kellgren– Lawrence scale No pervious surgical/ steroid injection history with in last 6month.
Exclusion criteria:
Bony abnormalities that affected knee, , , Plan of surgical procedure with in the time frame of study Have history of injury that may cause OA Systemic inflammatory and medical disease that have prevent physical activity
Age
From 40 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 70
Actual sample size reached: 61
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done as Lottery Method
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants and Data analyzer was blind did not know belong to which group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board the University of Lahore
Street address
L 103 DHA rahber Phase 2 Lahore Pakistan
City
Lahore
Postal code
54000
Approval date
2021-04-05, 1400/01/16
Ethics committee reference number
IRB-UOL-FAHS/831-VII/2021

Health conditions studied

1

Description of health condition studied
KNEE OSTEOARTHRITIS
ICD-10 code
M19.91
ICD-10 code description
Primary osteoarthritis, unspecified site

Primary outcomes

1

Description
Pain
Timepoint
6th Week
Method of measurement
Pain by Visual Analog scale(VAS)

2

Description
Function
Timepoint
6th Week
Method of measurement
Function by subscale of Knee Injury and Osteoarthritis Outcome Score(KOOS)

3

Description
Quality of life
Timepoint
6th Week
Method of measurement
Quality of life by subscale of Knee Injury and Osteoarthritis Outcome Score(KOOS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Experimental group received progressive hip and knee strengthening exercises for 6th week, 4 session per week on alternative days, frequency of exercise was 3 set with 10 repetition in each set, session completed in 40 min, 2 rest, Thera-Band with medium resistance to heavy resistance was used .
Category
Rehabilitation

2

Description
Control group: received knee strengthening exercises for 6th week, 4 session per week on alternative days, frequency of exercise was 3 set with 10 repetition in each set, session completed in 40 min, 2 rest, Thera-Band with medium resistance to heavy resistance was used .
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
WAPDA TEACHING HOSPITAL COMPLEX LAHORE
Full name of responsible person
Abid Javaid
Street address
210-Ferozpur Road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 37564705
Fax
+92 42 35232285
Email
abidminhas.pt@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Mariam Umer Hayat
Street address
No 103 L DHA Raber Lahore Pakistan
City
Lahore
Postal code
54000
Phone
+92 321 4437350
Email
mariamumerhayat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
self
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Mariam Umer Hayat
Position
Mphill student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
L 103 DHA rahber phase 2 Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 4437350
Email
mariamumerhayat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Mariam Umer Hayat
Position
Mphil student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
L103 DHA rahber phase 2
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 4437350
Email
mariamumerhayat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
the university of Lahore
Full name of responsible person
Mariam Umer Hayat
Position
Mphill student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
L103 DHA rahber phase 2 Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 4437350
Email
mariamumerhayat@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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