Healthy Clinical Trial
Official title:
Dose-Response Relationship of Ambulatory Load and Cartilage - Pilot Study
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.
The current state of research in the field and of our own research clearly shows that the in
vivo mechanobiology of articular cartilage is poorly understood. Previous results of changes
in cartilage biomarker concentrations after ambulatory exercise raise the following question:
Do load-induced changes in blood biomarkers for articular cartilage (COMP) depend on the
physiological load magnitude? To generate initial data for answering this question, we will
establish the experimental framework to systematically study the in vivo mechanobiology of
human articular cartilage to address the following aims.
- To obtain pilot data for investigating the in vivo dose-response relationship of
weight-bearing and blood levels of mechanosensitive biomarker of articular cartilage
using controlled load- bearing as experimental paradigm.
- To provide pilot data for comparing ambulatory biomechanics between the controlled load-
bearing conditions.
The experimental setting consists of a 30-minutes walking stress test under three loading
conditions: A: 80 %, B: 100% and C: 120% bodyweight. Unloading will be achieved through an
unloading system and additional loading with an adjustable weight vest. Before and after the
walking stress test, venous blood samples will be taken at five time points. The biomarker
concentration is measured with a commercial available enzyme-linked immunosorbent assay
(ELISA).
Hypothesis Our working hypothesis is that there is a dose-response relationship between the
temporarily increased or decreased load and the load-induced change in COMP level in the
blood serum. We assume that serum COMP concentration increases with increasing accumulated
load on the knee cartilage simulated through the three different loading conditions.
Design The design of the pilot study is a controlled multimodal data collection (biological,
biomechanical) with block randomization. Specifically, we will collect blood samples and
biomechanical (kinematic and pressure) data. We will determine the relationship between the
serum blood concentration and the biomechanical data.
Because this is a cross-over study, all participants will perform the same three walking
stress tests but in random order. Each participant of the study will be tested for 2.5 hours
on 3 separate days.
Method In this experiment, we will test 24 healthy participants (12 male, 12 female) on 3
test days under three different loading conditions in a randomized block design. On each test
day, participants will complete walking stress test for 30-minutes with A: 80%, B: 100% and
C: 120% of their bodyweight. Through the modified bodyweight we generate higher or lower
forces on the knee cartilage, which should affect the COMP concentration in the blood serum.
To measure the change in serum COMP concentration, blood samples will be taken at five time
points before and after the walking stress test. The blood samples are taken by a study
nurse. For the venipuncture, a thin, sterile, disposable vein catheter is placed in the
antecubital vein. The catheter stays in the vein for the entire 2.5 hours of the experiment.
Blood samples will be collected and allowed to clot for 30-minutes. Serum will be separated
and frozen in aliquots to -20°C within 1 hour of collection and then transferred for storage
at -80°C until assayed. Serum biomarker concentrations will be determined using commercial
ELISAs.
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