- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06621784
Core Stabilization Exercises in Patients with Knee Osteoarthritis
The Effect of Core Stabilization Exercises on Pain, Function, Balance, and Quadriceps Muscle Thickness in Patients with Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee osteoarthritis is becoming a significant public health problem with the aging population. While there is no definitive cure, exercise is the main approach to treatment. Various types of exercises are being studied for their effectiveness in osteoarthritis treatment, and recently, core stabilization exercises have been highlighted for their role in lower extremity pathologies. In this study, we aimed to investigate the effects of these exercises on pain, balance, quality of life, function, and quadriceps muscle thickness in patients with knee osteoarthritis.
This study was designed as a randomized controlled double-blind clinical trial. Thirty-two patients were randomly divided into two groups: a conventional exercise group and a conventional+core group. A total of 18 home exercise sessions, performed three times per week for six weeks, were planned.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bahçelievler
-
Istanbul, Bahçelievler, Turkey
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of bilateral stage II or III knee osteoarthritis according to the Kellgren and Lawrence grading system
- Aged between 50 and 65 years
- Having a complaint of knee pain for at least 6 months
- No systemic diseases that may hinder exercise (such as uncontrolled hypertension, cardiac arrhythmia, heart failure, neurological sequelae, joint deformities, malignancy, etc.)
Exclusion Criteria:
- Having received physical therapy in the last 6 months
- Having undergone knee injection in the last 6 months
- Having had knee surgery
- Morbid obesity
- Presence or history of malignancy
- Individuals with severe visual impairment
- Individuals with a history of neurological or vestibular diseases that could cause balance problems, or patients using medications that may affect balance
- Individuals with serious cardiac, respiratory, or uncontrolled metabolic diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional exercise (control) group
The first group followed a standard home exercise program for three times per week for six weeks
|
In the first group of our study, we prescribed exercises that have been proven effective in many studies, are frequently prescribed, and focus on joint range of motion and quadriceps strengthening
|
|
Active Comparator: core exercise group
The second group followed a standard home exercise program and core stabilization exercises for three times per week for six weeks
|
In the first group of our study, we prescribed exercises that have been proven effective in many studies, are frequently prescribed, and focus on joint range of motion and quadriceps strengthening
In most studies, exercises focused on the extremities have been researched.
We believe that the positive effects of the core region on walking and postural stability will play a significant role in the treatment of knee osteoarthritis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcome Score total and subscale scores after a 6-week exercise program
Time Frame: Baseline and 1 week after the 6-week exercise program
|
The Knee Injury and Osteoarthritis Outcome Score is scored on a scale from 0 to 100, where 0 represents extreme knee problems and 100 indicates no knee problems.
Higher scores indicate a better outcome, reflecting less pain and better function.
|
Baseline and 1 week after the 6-week exercise program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in single-leg stance test durations after a 6-week exercise program
Time Frame: Baseline and 1 week after the 6-week exercise program
|
In the Single Leg Stance Test, the participant is initially asked to keep their eyes open.
Then, one foot is lifted without touching the supporting leg.
The participant is instructed to close their eyes and is expected to maintain balance for 30 seconds.
The duration of standing on one leg during this time is recorded.
If the lifted limb touches the supporting leg, the foot touches the ground, there is swaying or hopping, or if external support is used, it is considered a balance disturbance.
|
Baseline and 1 week after the 6-week exercise program
|
|
Change in quadriceps femoris muscle thickness after a 6-week exercise program
Time Frame: Baseline and 1 week after the 6-week exercise program
|
For the bilateral examination of the muscle thickness of the vastus intermedius and rectus femoris, patients will be positioned in a supine position with knees fully extended.
Horizontal imaging will be performed at the midpoint of the line between the anterior superior iliac spine and the upper part of the patella.
The average of three measurements will be recorded as the muscle thickness.
All measurements will be repeated three times, and the average of these measurements will be used for analysis.
|
Baseline and 1 week after the 6-week exercise program
|
|
Change in Visual Analog Scale at rest and during activity after a 6-week exercise program
Time Frame: Baseline and 1 week after the 6-week exercise program
|
Pain intensity will be evaluated with the Visual Analog Scale (VAS). Patients will be asked about the average pain intensity that they had felt at rest and during activity. Therefore, a score closer to 10 reflects a more severe pain experience, while a score of 0 indicates the absence of pain. |
Baseline and 1 week after the 6-week exercise program
|
Collaborators and Investigators
Investigators
- Principal Investigator: İrem Setenay ÖZKAN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/377
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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