Healthy Clinical Trial
— COMPOfficial title:
Dose-Response Relationship of Ambulatory Load and Cartilage - Pilot Study
NCT number | NCT03455010 |
Other study ID # | 2017-01006 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 5, 2017 |
Est. completion date | July 31, 2019 |
Verified date | September 2019 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The research question is if there is a dose-response relationship between blood biomarkers
for articular cartilage and the magnitude of physiological load. To investigate this load
induced biomarker change, the participants will complete a 30-minute walking test under three
loading conditions: A: 80%, B: 100% C: 120% of their respective bodyweight (Fig. 1).
The main biomarker we are interested in is called cartilage oligomeric matrix protein (COMP).
Serum COMP levels are increased immediately after 30-min running but there is no
dose-response relationship shown yet.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 31, 2019 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Age between 18 and 30 years - being physically active (> 2/week) - body mass index (BMI) <30 kg/m2 Exclusion Criteria: - previous knee injury - neuromuscular condition affecting gait |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel | Basel Stadt |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | University of Erlangen-Nürnberg |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | Age in years | At enrollment | |
Other | Sex | male or female | At enrollment | |
Other | Body mass index | BMI in kg/m2 | At enrollment | |
Other | Knee function | Knee Osteoarthritis Outcome Score measured by questionnaire (best score: 100 - no limitations; worst score: 0) | At enrollment | |
Primary | Load-induced serum Cartilage Oligomeric Matrix Protein concentration | Change in serum concentration during 30-minute walking exercise determined by commercial ELISA 30 min before to 2 hours after 30-minute walking exercise | 3 hours | |
Secondary | Overall ground reaction force impulse | Area under the ground reaction curve multiplied by number of steps taken during 30-minute walking exercise | 30 minutes | |
Secondary | Dynamic range of motion lower extremity joints | Min to max joint angles (ankle, knee, hip) measured using RehaGait (inertial measurement units) | 30 minutes |
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