NCT05925244

Brief Summary

The serum concentration of cartilage oligomeric matrix protein (sCOMP) has been considered a mechano-sensitive biomarker of articular cartilage turnover, and N-propeptide of type II collagen (PIIANP) is a proposed biomarker of type II collagen synthesis. Few studies have investigated both the anabolic and turnover response of articular cartilage as a result of acute changes in body weight mass during exercise. Using a repeated measures cross-over design, fifteen healthy adults (age 18-30 years) performed three, 30-minute bouts of treadmill walking exercise under 3 loading conditions: (1) control (no alteration to body mass); (2) loaded (12% increase in body mass using a weighted vest); and (3) unloaded (12% decrease in body mass using lower body positive pressure). Venous blood was collected before, immediately after, and 15 and 30 minutes after exercise to investigate cartilage turnover (sCOMP) and anabolism (PIIANP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 21, 2023

Last Update Submit

June 28, 2023

Conditions

Keywords

articular cartilagewalking exercisesCOMPPIIANP

Outcome Measures

Primary Outcomes (2)

  • Serum cartilage oligomeric matrix protein (sCOMP)

    The systemic blood serum concentration of sCOMP was evaluated in all participants under the 3 conditions in a crossover trial.

    sCOMP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.

  • N-propeptide of type II collagen (PIIANP)

    The systemic blood serum concentration of PIIANP was evaluated in all participants under the 3 conditions in a crossover trial.

    PIIANP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.

Study Arms (3)

Control

EXPERIMENTAL

The control condition did 30 minutes of walking exercise with their own body mass.

Other: Control Condition

+12% Body Mass

EXPERIMENTAL

The +12% body mass condition did 30 minutes of walking exercise wearing a weighted vest with +12% of their body mass applied.

Other: +12% Body Mass

-12% Body Mass

EXPERIMENTAL

The -12% body mass condition did 30 minutes of walking exercise using a lower body positive pressure treadmill with -12% of their body mass applied.

Other: -12% Body Mass

Interventions

Control (no alteration to body mass).

Control

Unloaded walking exercise (12% decrease in body mass using lower body positive pressure).

-12% Body Mass

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • years old

You may not qualify if:

  • Traumatic injury to the lower extremity in the past year
  • Hip, knee, or ankle surgery
  • Radiographic evidence of joint degeneration
  • Cardiovascular disease
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Chronic reactive arthritis
  • Renal problems requiring peritoneal dialysis or hemodialysis
  • Not currently using any prescription or non-prescription medications and/or nutritional supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • de Vasconcelos BM, Peeler JD, Scribbans T, Cornish SM. A preliminary study on the effect of loaded and unloaded exercise on N-propeptide of type II collagen and serum cartilage oligomeric matrix protein activity of articular cartilage in healthy young adults. Appl Physiol Nutr Metab. 2023 Dec 1;48(12):954-961. doi: 10.1139/apnm-2023-0124. Epub 2023 Aug 9.

Study Officials

  • Stephen M Cornish, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

September 27, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

The data will not be available to other researchers as we do not have ethical approval to do so.

Locations