- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383740
Test-Retest Reliability of a Submaximal Exercise Test in Patients With Hip and Knee Osteoarthritis
Test-Retest Reliability of a Submaximal Exercise Test in Patients With Hip- and/or Knee Osteoarthritis
The aim is to evaluate the test-retest reliability of the primary care-adapted Ekblom-Bak submaximal ergometer bicycle test in patients with hip- and/or knee osteoarthritis (OA).
Forty patients with hip- and/or knee OA eligible for the Swedish national OA treatment program in primary care are to be recruited. After screening for contraindications, participants will perform the aEB-test twice within 1-2 weeks.
The investigators hypothezise that the test will demonstrate acceptable test-retest reliability in patients with hip- and/or knee OA.
To establish reliability is essential for future studies using this test in this population and may support its integration into routine clinical assessment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel Karsberg Zotterman, MSc
- Phone Number: +46739298119
- Email: daniel.karsberg.zotterman@vgregion.se
Study Contact Backup
- Name: Stefan Lundqvist, PhD
- Phone Number: +46762276179
- Email: stefan.lundqvist@vgregion.se
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently listed on the waiting list for an osteoarthritis rehabilitation program due to clinically diagnosed hip and/or knee osteoarthritis.
Exclusion Criteria:
- Another primary cause of symptoms or disability, such as inflammatory joint disease or fracture.
- Another condition currently causing more symptoms than osteoarthritis, for example fibromyalgia.
- Insufficient understanding of written and spoken Swedish.
- Medication that affects heart rate.
- Contraindications for a submaximal ergometer bicycle test according to the screening protocol, such as heart disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Forty patients with osteoarthritis in hip or knee
Forty patients with hip or knee osteoarthritis on the waiting list for usual rehabilitation care will be recruited.
The patientes will be screened for contraindications, and, if eligible, will complete a submaximal cycle ergometer test twice within one week.
|
Performing a submaximal cycle ergometer test twice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated VO2-max value.
Time Frame: Time between first and second submaximal cycle ergometer test should be one week.
|
An estimated VO2-max value is obtained by performing the Ekblom Bak submaximal cycle ergometer test.
|
Time between first and second submaximal cycle ergometer test should be one week.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Test-retest_adapted_EB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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