- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06120920
Comparison of Hip Strengthening Exercises and Core Stability Exercises in Patients With Knee Osteoarthritis
November 1, 2023 updated by: University of Lahore
Knee Osteoarthritis is a chronic degenerative joint disease with complex etiology that results in loss of normal joint function due to damage to the articular cartilage.
It is characterized by pain, swelling, inflammation and narrowing in articular cartilage.
Hip muscle weakness has been observed in persons with knee OA and poor core stability may be one of the other contributing factors that lead to knee OA development as well as its progression.
Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury.
So the lumbopelvic stability is vital to support loads on the knee joint.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Osteoarthritis (OA) of the knee joint results in chronic pain and functional decline among older adults.
Osteoarthritis is a degenerative joint disease with complex etiology that results in loss of normal joint function due to narrowing of the articular cartilage.
The pathogenesis of knee OA is the result of interaction between mechanical loading, articular cartilage damage, and incomplete repair mechanisms.
These changes eventually cause progressive joint degeneration and failure, leading to chronic knee pain and progressive restriction of knee joint mobility.
Core muscle endurance deficiency leads to an increase in the loading of the knee, as well as in knee joint contact force during dynamic movement.
Hence, poor core stability may be one of the contributing factors that lead to knee OA development as well as its progression.
On the other hand hip muscle weakness has been observed in persons with knee OA and to increase the medial compartment loading on the knee joint.
This increases the force on the medial compartment of the stance leg, and the disease starts succeeding.
Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury.
Considering the strength deficits in the hip muscles as well as core muscles, a targeted exercise program for knee osteoarthritis include hip muscle strengthening and core strengthening might reduce the medial compartment loading and improve knee symptoms.
Core stability and hip strengthening exercise along with Knee Physical therapy and conventional therapy as a mode of treatment in knee OA and it may help clinicians to treat subjects with knee OA at risk of a decline in muscle strength, range of motion, functional disability and pain.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ashfaq Ahmad, PhD
- Phone Number: 0300-9449192
- Email: ashfaq.ahmad@uipt.uol.edu.pk
Study Contact Backup
- Name: Waqar Afzal, PhD
- Phone Number: 0321-4668377
- Email: Waqarafzal621@gmail.com
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54770
- Recruiting
- The University of Lahore
-
Contact:
- Muhammad Waqar Afzal, PhD
- Phone Number: 0321-4668377
- Email: Waqarafzal621@gmail.com
-
Principal Investigator:
- Rashid Hafeez Nasir, M.Phill
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age: 40-65
- Diagnose case of knee OA grade 2, 3.
- Side of involved leg: right or left.
- Unilateral knee.
- Gender both male and female.
- Pre-diagnostics referred by orthopedics.
- Able to walk without gait aids.
Exclusion Criteria:
- Inflammatory arthritis
- Osteoarthritis of the hips
- Having had previous knee or hip surgery.
- Patient who had amputated leg and who don't have any lower extremity disorders.
- Received intra-articular injection within 6 months.
- Non-steroidal anti-inflammatory drug or cortisone use over an extended period.
- Patients who had neurological and muscle problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises.
Patient will receive Conventional physical therapy include hot pack, Tens and routine knee strengthening exercises with core stability exercises.
|
Conventional physical therapy consists of hot pack application and transcutaneous electric stimulation (TENS) and routine knee strengthening exercises in addition with core stability exercises in three sessions per week for 4 weeks.
Core stability exercises include bent knee hollow hold, bridging, supine toe tap and knee strengthening exercises include knee flexion strengthening exercises and knee extension isometric exercises.
Other Names:
Conventional physical therapy consists of hot pack application, Tens and routine knee exercise program same as group A and in addition with hip strengthening exercises.
Hip strengthening exercises include hip flexion and extension strengthening exercises and hip internal rotation and external rotation and hip adduction and abduction strengthening exercises.C
|
Experimental: Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.
In this group, patient will receive conventional physical therapy include hot pack, Tens and routine knee exercises with hip strengthening exercises
|
Conventional physical therapy consists of hot pack application and transcutaneous electric stimulation (TENS) and routine knee strengthening exercises in addition with core stability exercises in three sessions per week for 4 weeks.
Core stability exercises include bent knee hollow hold, bridging, supine toe tap and knee strengthening exercises include knee flexion strengthening exercises and knee extension isometric exercises.
Other Names:
Conventional physical therapy consists of hot pack application, Tens and routine knee exercise program same as group A and in addition with hip strengthening exercises.
Hip strengthening exercises include hip flexion and extension strengthening exercises and hip internal rotation and external rotation and hip adduction and abduction strengthening exercises.C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assessment
Time Frame: Pain intensity will be measured at the baseline at the time of recruitment and change in pain intensity will be measured at 3rd and 4th week of interventions
|
Pain intensity will be measured using Visual Analogue Scale.
It consist of a 100mm line, with to end points, 0 representing no pain and 10 representing pain as bad as it could be possible.
|
Pain intensity will be measured at the baseline at the time of recruitment and change in pain intensity will be measured at 3rd and 4th week of interventions
|
Knee Range of Motion
Time Frame: Knee Range of Motion will be measured as baseline at the time of recruitment and change in range of motion will be measured at 3rd and 4th week of treatment.
|
ROM is measured by goniometer.: A normal range of knee joint is 0 degrees of knee extension (a fully straightened knee) and 135 degrees of knee flexion.A half circle long-arm metallic goniometer, ranging from 0 to 180°, with 1° interval marking was used.
It had a central fulcrum, a stationary or fixed arm, and a pivoting or moving arm.
Both arms were 30 cm long.
|
Knee Range of Motion will be measured as baseline at the time of recruitment and change in range of motion will be measured at 3rd and 4th week of treatment.
|
Functional Disability
Time Frame: Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 3rd and 4th week of intervention.
|
The functional disability assessed by the self-reported questionnaire the Knee injury and Osteoarthritis Outcome Score (KOOS).Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
|
Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 3rd and 4th week of intervention.
|
Knee Muscle Strength
Time Frame: Knee Muscle Strength will be observed as baseline at the time of recruitment and change in muscle strength will be observed at the 3rd and 4th week of treatment
|
Knee Muscle Strength will be observed by Manual Muscle Testing Scale.
This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly 1.Flicker of movement,2.through
full range actively with gravity counterbalanced,3.through
full range actively against gravity,4.through
full range actively against some resistance,5.Through full range actively against strong resistance.
|
Knee Muscle Strength will be observed as baseline at the time of recruitment and change in muscle strength will be observed at the 3rd and 4th week of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Up and Go Test (TUG)
Time Frame: Time Up and Go Test will be observed as baseline at the time of recruitment and change in function will be observed at 3rd and 4th week of treatment.
|
TUG is used to evaluate function.
It assesses the patient's capability to stand from the chair, then walk for three meters, turn, walk back, and sit on the same chair.
The TUG is highly responsive and valid to determine alteration in patients with OA of the knee.
The minimum clinically important differences (MCID) is reported to be 0.8-1.4s
for the TUG in patients with OA of the knee.
|
Time Up and Go Test will be observed as baseline at the time of recruitment and change in function will be observed at 3rd and 4th week of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dr.Waqar Afzal, PhD, The University of Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2023
Primary Completion (Estimated)
November 21, 2023
Study Completion (Estimated)
November 30, 2023
Study Registration Dates
First Submitted
November 1, 2023
First Submitted That Met QC Criteria
November 1, 2023
First Posted (Actual)
November 7, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-UOL-545-10-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Participants data that underlies the results after de-identification.
IPD Sharing Time Frame
Immediately after publication
IPD Sharing Access Criteria
Researchers who provide methodological sound proposal
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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