Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intra rater reliability
Inter rater reliability
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis, Knee focused on measuring 30 seconds chair stand test, Performance test, Reliability
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Närhälsan Lidköping Rehabmottagning
- Närhälsan Skara Rehabmottagning
- Närhälsan Trollhättan Rehabmottagning
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Test-retest reliability
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03855813
First Posted
February 24, 2019
Last Updated
September 28, 2023
Sponsor
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT03855813
Brief Title
Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.
Official Title
Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
July 25, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
30 seconds chair stand test, Performance test, Reliability
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test-retest reliability
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Intra rater reliability
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Inter rater reliability
Intervention Description
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.
Primary Outcome Measure Information:
Title
30 seconds chair stand test as self-test.
Description
30 seconds chair stand test will be used as a self-test. Number of stands will be counted.
Time Frame
Two occasions within approximately three days to establish intra rater reliability
Title
30 seconds chair stand test, comparison self-test vs clinical test.
Description
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.
Time Frame
Two occasions within approximately seven days to establish inter rater reliability
Secondary Outcome Measure Information:
Title
Pain intensity during 30 seconds chair stand test
Description
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.
Time Frame
Three occasions within approximately 14 days, between the first and last testing with 30 seconds chair stand test.
Title
Osteoarthritis pain
Description
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.
Time Frame
Baseline
Title
Difficulties with activities due to knee pain
Description
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.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Demographic data
Description
Demographic data such as age, sex, body mass index (BMI), duration osteoarthritis diagnosis, other diseases, education level, origin, pain location, pain duration (knee). Patients' body weight and height will be measured to calculate the BMI.
Time Frame
Baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Nordeman, RPT, PhD
Organizational Affiliation
Research & Development Centre Södra Älvsborg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Närhälsan Lidköping Rehabmottagning
City
Lidköping
State/Province
Vastra Gotaland
Country
Sweden
Facility Name
Närhälsan Skara Rehabmottagning
City
Skara
State/Province
Vastra Gotaland
Country
Sweden
Facility Name
Närhälsan Trollhättan Rehabmottagning
City
Trollhättan
State/Province
Vastra Gotaland
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23680877
Citation
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.
Results Reference
background
PubMed Identifier
10380242
Citation
Jones 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.
Results Reference
background
PubMed Identifier
18381179
Citation
Hawker 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.
Results Reference
background
PubMed Identifier
18294869
Citation
Perruccio 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.
Results Reference
background
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Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.
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