Knee OsteoarthritisNCT06034665
Estimation of the MCID for Patients With Knee Osteoarthritis
A study testing Exercise in people with Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 5 Dec 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA)
- Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
- Participants with age between 50 and 70 years old
- Being able to walk without using an assistive device
- Having a body mass index of less than 30 kg/m²
- Pain severity is between 3 and 7 according to the Numerical Pain Rating Scale
Who cannot join
- Patients who received physical therapy or intra-articular injections in the last 6 months
- Receiving an indication for surgery
- Have severe hearing, vision and speech impairment
- Having serious systemic and cardiovascular diseases that interfere with exercise
- Having a lower extremity deformity
- Patients with acute inflammation of the knee
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University Physiotherapy and Rehabilitation Application and Research Center
Istanbul
About this study
Official title: Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis
Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment.
It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed.
Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise
- Keywords
- knee osteoarthritis, mcid, exercise, rehabilitation
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | All patients will receive an exercise rehabilitation program tailored to their needs. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: Baseline, after 15 session and 4 months follow up
KOOS
Knee Injury and Osteoarthritis Outcome Score
Measured: Baseline, after 15 session and 4 months follow up
LEFS
Lower Extremity Functional Scale
Measured: Baseline, after 15 session and 4 months follow up
Knee Range of Motion
Range of motion assessment with goniometer
Measured: Baseline, after 15 session and 4 months follow up
Secondary outcomes (1)
30s sit to stand test
For functional assessment, patient sit and stand for 30 seconds
Measured: Baseline, after 15 session and 4 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Feb 2022
- Primary completion4 Jun 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Celik, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034665
- Sponsor's protocol ID
- DR2022
- Status last verified
- Jan 2024
- First submitted
- 22 May 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of The Minimal Clinically Important Difference (MCID) for Commonly Used Outcome Measures in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06034665
- Acronym / sponsor ID
- DR2022
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, mcid, exercise, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 13 Sep 2023 (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.
Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these scales are needed to understand the change in patients after treatment and to manage the treatment.
It is also one of the most important data in calculating the MCID sample size. Aim: In the literature, MCID studies for exercise applied to knee OA are limited especially for those who did not undergo surgery. Thus new studies are needed.
Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the study. Participants will be included in an exercise program tailored to their needs for 15 sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in the baseline, after treatments and in the 4th month follow up.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Other: ExerciseAll patients will receive an exercise rehabilitation program tailored to their needs. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be diagnosed with knee OA according to the criteria of the American Society of Rheumatology (ACR) (Diagnosis of primary knee OA)
- Stage 2 or 3 according to Kellgren Lawrence radiological staging criteria
- Participants with age between 50 and 70 years old
- Being able to walk without using an assistive device
- Having a body mass index of less than 30 kg/m²
Key exclusion criteria (6 listed)
- Patients who received physical therapy or intra-articular injections in the last 6 months
- Receiving an indication for surgery
- Have severe hearing, vision and speech impairment
- Having serious systemic and cardiovascular diseases that interfere with exercise
- Having a lower extremity deformity
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 |
|---|---|---|
| ExerciseAll patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions. | Other | Exercise |
Primary outcome
WOMAC
Time frame: Baseline, after 15 session and 4 months follow up
Western Ontario and McMaster Universities Osteoarthritis Index
KOOS
Time frame: Baseline, after 15 session and 4 months follow up
Knee Injury and Osteoarthritis Outcome Score
LEFS
Time frame: Baseline, after 15 session and 4 months follow up
Lower Extremity Functional Scale
Knee Range of Motion
Time frame: Baseline, after 15 session and 4 months follow up
Range of motion assessment with goniometer
1 secondary outcome
30s sit to stand test
Time frame: Baseline, after 15 session and 4 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Knee Osteoarthritis, run by Istanbul University 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WOMAC (time frame: Baseline, after 15 session and 4 months follow up). The study lists 4 primary outcomes in all. 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 9 Jan 2024.