Exercise TrainingNCT06621784
Core Stabilization Exercises in Patients with Knee Osteoarthritis
A study testing Core stabilization exercises and Classical exercise therapy in people with Exercise Training and Osteoarthritis, Knee, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Exercise plays a key role in the treatment of knee osteoarthritis, but there is no clear evidence on which type of exercise is most effective. Recent studies highlight the benefits of core stabilization exercises for improving knee stability. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Exercise Training, Osteoarthritis, Knee, Core Stability
- What is being tested?
- Core stabilization exercises and Classical exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2023to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Bahçelievler
About this study
Official title: The Effect of Core Stabilization Exercises on Pain, Function, Balance, and Quadriceps Muscle Thickness in Patients with Knee Osteoarthritis
Exercise plays a key role in the treatment of knee osteoarthritis, but there is no clear evidence on which type of exercise is most effective. Recent studies highlight the benefits of core stabilization exercises for improving knee stability. This study aims to demonstrate the effects of adding core stabilization exercises to conventional exercise therapy for patients with knee osteoarthritis.
Read the 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.
- Conditions
- Exercise Training, Osteoarthritis, Knee, Core Stability, Muscle Thickness of the Quadriceps Femoris, Balance
- Being tested
- Core stabilization exercises, Classical exercise therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization exercisesOther
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.
Classical exercise therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Traditional exercise (control) group | Active comparator | The first group followed a standard home exercise program for three times per week for six weeks Receives: Other: Classical exercise therapy |
| core exercise group | Active comparator | The second group followed a standard home exercise program and core stabilization exercises for three times per week for six weeks Receives: Other: Core stabilization exercises; Other: Classical exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome Score total and subscale scores after a 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.
Measured: Baseline and 1 week after the 6-week exercise program
Secondary outcomes (3)
Change in single-leg stance test durations after a 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.
Measured: Baseline and 1 week after the 6-week exercise program
Change in quadriceps femoris muscle thickness after a 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.
Measured: 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
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.
Measured: Baseline and 1 week after the 6-week exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start23 Jun 2023
- Primary completion23 Jun 2024
- Study completion9 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İrem Setenay Özkan, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- İrem Setenay ÖZKAN, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621784
- Sponsor's protocol ID
- 2023/377
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Exercises on Pain, Function, Balance, and Quadriceps Muscle Thickness in Patients with Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06621784
- Acronym / sponsor ID
- 2023/377
- Conditions
- Exercise Training, Osteoarthritis, Knee, Core Stability, Muscle Thickness of the Quadriceps Femoris, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 9 Oct 2024 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise plays a key role in the treatment of knee osteoarthritis, but there is no clear evidence on which type of exercise is most effective. Recent studies highlight the benefits of core stabilization exercises for improving knee stability. This study aims to demonstrate the effects of adding core stabilization exercises to conventional exercise therapy for patients with knee osteoarthritis.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional exercise (control) group | Active comparator | Other: Classical exercise therapyThe first group followed a standard home exercise program for three times per week for six weeks |
| core exercise group | Active comparator | Other: Core stabilization exercises, Other: Classical exercise therapyThe second group followed a standard home exercise program and core stabilization exercises for three times per week for six weeks |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilization exercisesIn 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. | Other | core exercise group |
| Classical exercise therapyIn 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 | Other | Traditional exercise (control) group, core exercise group |
Primary outcome
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.
3 secondary outcomes
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
Change in quadriceps femoris muscle thickness after a 6-week exercise program
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İrem Setenay ÖZKAN principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercises and Classical exercise therapy in people with Exercise Training and Osteoarthritis, Knee, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.