Dose-Response Relationship of Ambulatory Load and Cartilage - Pilot Study

NCT03455010 | Completed

• 1 other identifier: 2017-01006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Ambulatory load; Biomarker; Articular cartilage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall ground reaction force impulse

  30 minutes

• Dynamic range of motion lower extremity joints

  30 minutes

Other Outcomes (4)

• Age

  At enrollment

• Sex

  At enrollment

• Body mass index

  At enrollment

Study Arms (3)

Normal load

NO INTERVENTION

Healthy subjects walking for 30 minutes on a treadmill with normal body weight

Increased load

EXPERIMENTAL

Healthy subjects walking for 30 minutes on a treadmill with 20% additional body weight

Other: Increased load

Reduced load

EXPERIMENTAL

Healthy subjects walking for 30 minutes on a treadmill with 20% lower body weight

Other: Reduced load

Interventions

Increased load OTHER

Participants walk with 120% body weight achieved with a weight vest

Increased load

Reduced load OTHER

Participants walk with 80% body weight achieved by a dynamic unloading system

Reduced load

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 30 years
• being physically active (\> 2/week)
• body mass index (BMI) \<30 kg/m2

You may not qualify if:

• previous knee injury
• neuromuscular condition affecting gait

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Erlangen-Nürnberg: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Annegret Muendermann, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible because the experimental condition is obvious. Participants and testers cannot influence outcome parameters.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled multimodal data collection (biological, biomechanical) with block randomization.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 6, 2018
• Study Start: July 5, 2017
• Primary Completion: September 30, 2017
• Study Completion: July 31, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)