HealthyNCT05925244
The Anabolic and Catabolic Effect of Loaded and Unloaded Exercise on Articular Cartilage Health
A study testing +12% Body Mass and -12% Body Mass in people with Healthy, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- +12% Body Mass and -12% Body Mass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 27 Sep 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- 18-30 years old
Who cannot join
- 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
Show all 9Show fewer
- Chronic reactive arthritis
- Renal problems requiring peritoneal dialysis or hemodialysis
- Not currently using any prescription or non-prescription medications and/or nutritional supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Study on the Effect of Loaded and Unloaded Exercise on Anabolic and Turnover Activity of Articular Cartilage in Healthy Young Adults
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).
- Conditions
- Healthy
- Being tested
- Control Condition, +12% Body Mass, -12% Body Mass
- Keywords
- articular cartilage, walking exercise, sCOMP, PIIANP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control ConditionOther
Control (no alteration to body mass).
+12% Body MassOther
Loaded walking exercise (12% increase in body mass using a weighted vest).
-12% Body MassOther
Unloaded walking exercise (12% decrease in body mass using lower body positive pressure).
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | The control condition did 30 minutes of walking exercise with their own body mass. Receives: 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. Receives: 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. Receives: Other: -12% Body Mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: PIIANP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start27 Sep 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen M Cornish, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925244
- Sponsor's protocol ID
- HS22322
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be available to other researchers as we do not have ethical approval to do so.
Publications
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.
PubMed 37556859
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Effect of Loaded and Unloaded Exercise on Anabolic and Turnover Activity of Articular Cartilage in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05925244
- Acronym / sponsor ID
- HS22322
- Conditions
- Healthy
- Keywords
- articular cartilage, walking exercise, sCOMP, PIIANP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Control ConditionThe control condition did 30 minutes of walking exercise with their own body mass. |
| +12% Body Mass | Experimental | Other: +12% Body MassThe +12% body mass condition did 30 minutes of walking exercise wearing a weighted vest with +12% of their body mass applied. |
| -12% Body Mass | Experimental | Other: -12% Body MassThe -12% body mass condition did 30 minutes of walking exercise using a lower body positive pressure treadmill with -12% of their body mass applied. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- 18-30 years old
Key exclusion criteria (9 listed)
- Traumatic injury to the lower extremity in the past year
- Hip, knee, or ankle surgery
- Radiographic evidence of joint degeneration
- Cardiovascular disease
- Ankylosing spondylitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control ConditionControl (no alteration to body mass). | Other | Control |
| +12% Body MassLoaded walking exercise (12% increase in body mass using a weighted vest). | Other | +12% Body Mass |
| -12% Body MassUnloaded walking exercise (12% decrease in body mass using lower body positive pressure). | Other | -12% Body Mass |
Primary outcome
Serum cartilage oligomeric matrix protein (sCOMP)
Time frame: sCOMP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.
The systemic blood serum concentration of sCOMP was evaluated in all participants under the 3 conditions in a crossover trial.
N-propeptide of type II collagen (PIIANP)
Time frame: PIIANP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.
The systemic blood serum concentration of PIIANP was evaluated in all participants under the 3 conditions in a crossover trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 37556859de 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.
- Individual participant dataSharing planned: No. The data will not be available to other researchers as we do not have ethical approval to do so.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Cornish, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing +12% Body Mass and -12% Body Mass in people with Healthy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum cartilage oligomeric matrix protein (sCOMP) (time frame: sCOMP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.