Dose-Response Relationship of Ambulatory Load and Cartilage - Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Load-induced serum Cartilage Oligomeric Matrix Protein concentration
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
Masking is not possible because the experimental condition is obvious. Participants and testers cannot influence outcome parameters.
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Normal load
Healthy subjects walking for 30 minutes on a treadmill with normal body weight
Increased load
Healthy subjects walking for 30 minutes on a treadmill with 20% additional body weight
Intervention: Increased load (Other)
Reduced load
Healthy subjects walking for 30 minutes on a treadmill with 20% lower body weight
Intervention: Reduced load (Other)
Outcomes
Primary Outcomes
Load-induced serum Cartilage Oligomeric Matrix Protein concentration
Time Frame: 3 hours
Change in serum concentration during 30-minute walking exercise determined by commercial ELISA 30 min before to 2 hours after 30-minute walking exercise
Secondary Outcomes
- Dynamic range of motion lower extremity joints(30 minutes)
- Overall ground reaction force impulse(30 minutes)