Osteoarthritis, KneeNCT03855813
Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.
A study testing Intra rater reliability and Inter rater reliability in people with Osteoarthritis, Knee, run by Vastra Gotaland Region at 3 sites in Sweden.
Trial summary
Background: It is estimated that 14% of the Swedish population have knee osteoarthritis. Common osteoarthritis symptoms are pain, stiffness and impaired physical function. To evaluate muscle strength in the lower extremities could indicate if there is a risk for a patient with osteoarthritis to worsen their disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Intra rater reliability and Inter rater reliability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 3 sitesSweden
- Study dates
- 27 Feb 2019to 25 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with knee osteoarthritis. The patients should have most problem with their knees, but are allowed to have osteoarthritis in other lower extremity joints.
- Independent in walking, with or without walking aids.
- Understand test instructions verbally and in writing.
Who cannot join
- Neurological disorders that affects the patients balance or gait.
- Severe somatic or mental illness that affect the physical functional performance or the ability to understand test instructions verbally or in text.
- Knee or hip replacement the past six months.
- Other knee surgery the past six months that could affect the physical functional performance.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Närhälsan Lidköping Rehabmottagning
Lidköping, Västra Götaland County
Närhälsan Skara Rehabmottagning
Skara, Västra Götaland County
Närhälsan Trollhättan Rehabmottagning
Trollhättan, Västra Götaland County
About this study
Background: It is estimated that 14% of the Swedish population have knee osteoarthritis. Common osteoarthritis symptoms are pain, stiffness and impaired physical function. To evaluate muscle strength in the lower extremities could indicate if there is a risk for a patient with osteoarthritis to worsen their disease. Increased muscle strength could improve physical function and pain for this patient group. A reliable self-test to evaluate physical function could help patients with diagnosed or suspected knee osteoarthritis to seek healthcare in time. The 30 seconds chair stand test (30 CST) is part of a test battery which is recommended to use for patients with osteoarthritis, both in research and in a clinical setting. It is a valid and a reliable measurement for patients with osteoarthritis. However, reliability studies of the 30 CST as a self-test is lacking.
Objective: To determine whether 30 CST is a reliable self-test to evaluate physical function among patients with knee osteoarthritis, we want to explore how much it differs in the test results when the patient is performing the test by herself and also compare it with when it is conducted in a clinical setting.
Read more
Methods: 147 participants with knee osteoarthritis will be recruited from three rehabilitations centers in primary care. The participant will perform the self-test twice at home, and the self-test will be compared with when the test is guided by a physical therapist at a rehabilitation center. The reliability results will be presented with an intraclass correlation coefficient and standard error measurement.
Estimated results: It is expected that the results from this study will clarify if 30 CST can be used as a self-test for persons with suspected or diagnosed/confirmed knee osteoarthritis. If this performance test show enough reliability to be used as a self-test, it could be used as an indicator if the patient should seek healthcare or not due to impaired function. To seek healthcare in an earlier phase usually require less efforts and often leads to shorter healthcare process. These improvements of the healthcare process could be of value to manage the expected future increase of osteoarthritis consultations to primary care.
Read the detailed description
The project leader will be visiting recruiting units to inform and educate about the study protocol and data collection procedure.
Patient recruitment
Patients with knee osteoarthritis will be recruited from three rehabilitations centers in region Västra Götaland, Sweden. When eligible participants have been identified according to inclusion criteria, the participants will get written information about the study, including informed consent, manual to the 30 CST self-test, and questionnaires.
Data Collection
30 CST: The 30 CST will be performed on an approximately 45 cm high chair without armrest (if possible). The participant will be asked to perform as many stands as possible during 30 seconds. Start position is sitting on the chair, and the arms should be crossed over the chest during the whole test. The stands must be to upright standing position (i.e. fully extended hips and knees), and back to sitting position. The patients pain intensity will be measured with numeric rating scale before and during the test.
Manual to the 30 CST self-test and questionnaires: The participants will get a description of how the self-test should be performed. The self-test should be performed twice with approximately two days apart, and the last measurement should be approximately one week before the planned physical therapist testing with the 30 CST. The self-test results will be sealed in an envelope together with the completed questionnaires (demographic data, Intermittent and Constant Osteoarthritis Pain (ICOAP), Knee injury and Osteoarthritis Outcome Score (KOOS-PS)). The patients will be bringing these data to their physical therapists till their next visit at the rehabilitation center.
Physical therapist testing: All physical therapists in the study will get an education about the study protocol and the 30 CST. The physical therapists will be blind of the self-test result during the testing. They will use the same manual for the 30 CST as the patients. Participants will be notified how well their 30 CST test results are compared to the normal population. The participants' length and weight will be measured by the physical therapist to calculate the body mass index.
Reporting for adverse events
If the patients or physical therapists have to cancel the test, they will be able to report the reason why they needed to cancel (e.g. increased pain, unsafe due to difficulties with patients balance).
Data management
All data will be coded and managed according to the General Data Protection Regulation. All data will be confidential and only authorized will have access to the patient registry. No individual information can be identified since the results will be presented at group level. Data will be saved for at least 10 years to enable audit.
Sample size
Sample size was calculated with statistical software program PASS 16. A sample size of 117 participants with two observations per participant for inter respectively intra rater reliability achieved a power of 80% to detect an intraclass correlation coefficient (ICC) of 0.8 with a significance level of 0.05. With an estimated 20% drop-out rate, 147 participants are planned to be recruited to the study.
Statistical analysis
Demographic data will be analyzed descriptively. It will be presented as number and percent, mean and standard deviation, and median and 25th to 75th percentiles. Relative reliability (inter and intra reliability) will be presented with an ICC using a 95% confidence interval. ICC-values > 0.8 indicate enough reliability and values > 0.9 represent optimal reliability. Absolute reliability will be presented with standard error measurement. The analyses will be made in SPSS with a significance level of p<0.05.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Intra rater reliability, Inter rater reliability
- Keywords
- 30 seconds chair stand test, Performance test, Reliability
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra rater reliabilityOther
Patients will perform the 30 seconds chair stand test as a self-test twice at home with approximately two days apart. The last self-test should be performed approximately one week before the testing with a physical therapist.
Inter rater reliabilityOther
Same patients performing the self-test will be tested by a physical therapist approximately one week after the last self-test. The physical therapist will be blind to the self-test results.
| Study group | Role | What they receive |
|---|---|---|
| Test-retest reliability | Other | Patients with knee osteoarthritis will perform the 30 seconds chair stand test as a self test twice at home to evaluate intra rater reliability. Same patients will be tested with the same performance test by a physical therapist to evaluate the inter rater reliability. Receives: Other: Intra rater reliability; Other: Inter rater reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 seconds chair stand test as self-test.
30 seconds chair stand test will be used as a self-test. Number of stands will be counted.
Measured: Two occasions within approximately three days to establish intra rater reliability
30 seconds chair stand test, comparison self-test vs clinical test.
30 seconds chair stand test will be used as a self-test and as a clinical test led by a physical therapist. Number of stands will be counted.
Measured: Two occasions within approximately seven days to establish inter rater reliability
Secondary outcomes (3)
Pain intensity during 30 seconds chair stand test
Pain intensity will be measured before and during the chair stand test with numeric rating scale between 0-10, where 0 means no pain and 10 worst imaginable pain.
Measured: Three occasions within approximately 14 days, between the first and last testing with 30 seconds chair stand test.
Osteoarthritis pain
Osteoarthritis pain will be measured with Measure of Intermittent and Constant Osteoarthritis Pain: ICOAP. The questionnaire consists of two subscales, a) constant pain and b) intermittent pain. The total score ranges between 0 to 100 where 0 means no pain and 100 means extreme pain.
Measured: Baseline
Difficulties with activities due to knee pain
Expericences of difficulties with activities due to patients knee pain will be measured with short version of Knee injury and Osteoarthritis Outcome Score (KOOS-PS). The total score ranges between 0-100 where 0 is great difficulties and 100 is no difficulties.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start27 Feb 2019
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with knee osteoarthritis will perform the 30 seconds chair stand test as a self-test twice at home to evaluate intra rater reliability. Same patients will be tested with the same performance test by a physical therapist to evaluate the inter rater reliability.
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lena Nordeman, RPT, PhD, Principal investigator, Research & Development Centre Södra Älvsborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855813
- Sponsor's protocol ID
- 255331_reliability30CST
- Status last verified
- Oct 2022
- First submitted
- 24 Feb 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
PubMed 23680877Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
PubMed 10380242Hawker GA, Davis AM, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Katz JN, Dieppe P. Development and preliminary psychometric testing of a new OA pain measure--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):409-14. doi: 10.1016/j.joca.2007.12.015.
PubMed 18381179Perruccio AV, Stefan Lohmander L, Canizares M, Tennant A, Hawker GA, Conaghan PG, Roos EM, Jordan JM, Maillefert JF, Dougados M, Davis AM. The development of a short measure of physical function for knee OA KOOS-Physical Function Shortform (KOOS-PS) - an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 May;16(5):542-50. doi: 10.1016/j.joca.2007.12.014. Epub 2008 Feb 21.
PubMed 18294869
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT03855813
- Acronym / sponsor ID
- 255331_reliability30CST
- Conditions
- Osteoarthritis, Knee
- Keywords
- 30 seconds chair stand test, Performance test, Reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 27 Feb 2019 (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: It is estimated that 14% of the Swedish population have knee osteoarthritis. Common osteoarthritis symptoms are pain, stiffness and impaired physical function. To evaluate muscle strength in the lower extremities could indicate if there is a risk for a patient with osteoarthritis to worsen their disease. Increased muscle strength could improve physical function and pain for this patient group. A reliable self-test to evaluate physical function could help patients with diagnosed or suspected knee osteoarthritis to seek healthcare in time. The 30 seconds chair stand test (30 CST) is part of a test battery which is recommended to use for patients with osteoarthritis, both in research and in a clinical setting. It is a valid and a reliable measurement for patients with osteoarthritis. However, reliability studies of the 30 CST as a self-test is lacking.
Objective: To determine whether 30 CST is a reliable self-test to evaluate physical function among patients with knee osteoarthritis, we want to explore how much it differs in the test results when the patient is performing the test by herself and also compare it with when it is conducted in a clinical setting.
Methods: 147 participants with knee osteoarthritis will be recruited from three rehabilitations centers in primary care. The participant will perform the self-test twice at home, and the self-test will be compared with when the test is guided by a physical therapist at a rehabilitation center. The reliability results will be presented with an intraclass correlation coefficient and standard error measurement.
Estimated results: It is expected that the results from this study will clarify if 30 CST can be used as a self-test for persons with suspected or diagnosed/confirmed knee osteoarthritis. If this performance test show enough reliability to be used as a self-test, it could be used as an indicator if the patient should seek healthcare or not due to impaired function. To seek healthcare in an earlier phase usually require less efforts and often leads to shorter healthcare process. These improvements of the healthcare process could be of value to manage the expected future increase of osteoarthritis consultations to primary care.
Detailed description
The project leader will be visiting recruiting units to inform and educate about the study protocol and data collection procedure.
Patient recruitment
Patients with knee osteoarthritis will be recruited from three rehabilitations centers in region Västra Götaland, Sweden. When eligible participants have been identified according to inclusion criteria, the participants will get written information about the study, including informed consent, manual to the 30 CST self-test, and questionnaires.
Data Collection
30 CST: The 30 CST will be performed on an approximately 45 cm high chair without armrest (if possible). The participant will be asked to perform as many stands as possible during 30 seconds. Start position is sitting on the chair, and the arms should be crossed over the chest during the whole test. The stands must be to upright standing position (i.e. fully extended hips and knees), and back to sitting position. The patients pain intensity will be measured with numeric rating scale before and during the test.
Manual to the 30 CST self-test and questionnaires: The participants will get a description of how the self-test should be performed. The self-test should be performed twice with approximately two days apart, and the last measurement should be approximately one week before the planned physical therapist testing with the 30 CST. The self-test results will be sealed in an envelope together with the completed questionnaires (demographic data, Intermittent and Constant Osteoarthritis Pain (ICOAP), Knee injury and Osteoarthritis Outcome Score (KOOS-PS)). The patients will be bringing these data to their physical therapists till their next visit at the rehabilitation center.
Physical therapist testing: All physical therapists in the study will get an education about the study protocol and the 30 CST. The physical therapists will be blind of the self-test result during the testing. They will use the same manual for the 30 CST as the patients. Participants will be notified how well their 30 CST test results are compared to the normal population. The participants' length and weight will be measured by the physical therapist to calculate the body mass index.
Reporting for adverse events
If the patients or physical therapists have to cancel the test, they will be able to report the reason why they needed to cancel (e.g. increased pain, unsafe due to difficulties with patients balance).
Data management
All data will be coded and managed according to the General Data Protection Regulation. All data will be confidential and only authorized will have access to the patient registry. No individual information can be identified since the results will be presented at group level. Data will be saved for at least 10 years to enable audit.
Sample size
Sample size was calculated with statistical software program PASS 16. A sample size of 117 participants with two observations per participant for inter respectively intra rater reliability achieved a power of 80% to detect an intraclass correlation coefficient (ICC) of 0.8 with a significance level of 0.05. With an estimated 20% drop-out rate, 147 participants are planned to be recruited to the study.
Statistical analysis
Demographic data will be analyzed descriptively. It will be presented as number and percent, mean and standard deviation, and median and 25th to 75th percentiles. Relative reliability (inter and intra reliability) will be presented with an ICC using a 95% confidence interval. ICC-values > 0.8 indicate enough reliability and values > 0.9 represent optimal reliability. Absolute reliability will be presented with standard error measurement. The analyses will be made in SPSS with a significance level of p<0.05.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with knee osteoarthritis will perform the 30 seconds chair stand test as a self-test twice at home to evaluate intra rater reliability. Same patients will be tested with the same performance test by a physical therapist to evaluate the inter rater reliability.
| Arm | Type | Receives |
|---|---|---|
| Test-retest reliability | Other | Other: Intra rater reliability, Other: Inter rater reliabilityPatients with knee osteoarthritis will perform the 30 seconds chair stand test as a self test twice at home to evaluate intra rater reliability. Same patients will be tested with the same performance test by a physical therapist to evaluate the inter rater reliability. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with knee osteoarthritis. The patients should have most problem with their knees, but are allowed to have osteoarthritis in other lower extremity joints.
- Independent in walking, with or without walking aids.
- Understand test instructions verbally and in writing.
Key exclusion criteria (4 listed)
- Neurological disorders that affects the patients balance or gait.
- Severe somatic or mental illness that affect the physical functional performance or the ability to understand test instructions verbally or in text.
- Knee or hip replacement the past six months.
- Other knee surgery the past six months that could affect the physical functional performance.
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 |
|---|---|---|
| Intra rater reliabilityPatients will perform the 30 seconds chair stand test as a self-test twice at home with approximately two days apart. The last self-test should be performed approximately one week before the testing with a physical therapist. | Other | Test-retest reliability |
| Inter rater reliabilitySame patients performing the self-test will be tested by a physical therapist approximately one week after the last self-test. The physical therapist will be blind to the self-test results. | Other | Test-retest reliability |
Primary outcome
30 seconds chair stand test as self-test.
Time frame: Two occasions within approximately three days to establish intra rater reliability
30 seconds chair stand test will be used as a self-test. Number of stands will be counted.
30 seconds chair stand test, comparison self-test vs clinical test.
Time frame: Two occasions within approximately seven days to establish inter rater reliability
30 seconds chair stand test will be used as a self-test and as a clinical test led by a physical therapist. Number of stands will be counted.
3 secondary outcomes
Pain intensity during 30 seconds chair stand test
Time frame: Three occasions within approximately 14 days, between the first and last testing with 30 seconds chair stand test.
Osteoarthritis pain
Time frame: Baseline
Difficulties with activities due to knee pain
Time frame: Baseline
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 29 Sep 2023.
- Background: PubMed 23680877Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
- Background: PubMed 10380242Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.
- Background: PubMed 18381179Hawker GA, Davis AM, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Katz JN, Dieppe P. Development and preliminary psychometric testing of a new OA pain measure--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):409-14. doi: 10.1016/j.joca.2007.12.015.
- Background: PubMed 18294869Perruccio AV, Stefan Lohmander L, Canizares M, Tennant A, Hawker GA, Conaghan PG, Roos EM, Jordan JM, Maillefert JF, Dougados M, Davis AM. The development of a short measure of physical function for knee OA KOOS-Physical Function Shortform (KOOS-PS) - an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 May;16(5):542-50. doi: 10.1016/j.joca.2007.12.014. Epub 2008 Feb 21.
- 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.
Lena Nordeman, RPT, PhD principal investigator
Research & Development Centre Södra Älvsborg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra rater reliability and Inter rater reliability in people with Osteoarthritis, Knee, run by Vastra Gotaland Region at 3 sites in Sweden.
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 3 inclusion and 4 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
30 seconds chair stand test as self-test. (time frame: Two occasions within approximately three days to establish intra rater reliability). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03855813, which also lists 4 linked publications.
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 29 Sep 2023.