NCT03855813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

September 29, 2023

Status Verified

October 1, 2022

Enrollment Period

4.4 years

First QC Date

February 24, 2019

Last Update Submit

September 28, 2023

Conditions

Keywords

30 seconds chair stand testPerformance testReliability

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Two occasions within approximately seven days to establish inter rater reliability

Secondary Outcomes (3)

  • Pain intensity during 30 seconds chair stand test

    Three occasions within approximately 14 days, between the first and last testing with 30 seconds chair stand test.

  • Osteoarthritis pain

    Baseline

  • Difficulties with activities due to knee pain

    Baseline

Other Outcomes (1)

  • Demographic data

    Baseline

Study Arms (1)

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.

Other: Intra rater reliabilityOther: Inter rater reliability

Interventions

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.

Test-retest reliability

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.

Test-retest reliability

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Närhälsan Lidköping Rehabmottagning

Lidköping, Västra Götaland County, Sweden

Location

Närhälsan Skara Rehabmottagning

Skara, Västra Götaland County, Sweden

Location

Närhälsan Trollhättan Rehabmottagning

Trollhättan, Västra Götaland County, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 23680877BACKGROUND
  • 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.

    PMID: 10380242BACKGROUND
  • 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.

    PMID: 18381179BACKGROUND
  • 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.

    PMID: 18294869BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lena Nordeman, RPT, PhD

    Research & Development Centre Södra Älvsborg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2019

First Posted

February 27, 2019

Study Start

February 27, 2019

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

September 29, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations