Skeletal MuscleNCT06677749
Skeletal Muscle Myokine Response to Acute Eccentric Exercise
A study testing Eccentric resistance-exercise in people with Skeletal Muscle, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the acute local skeletal muscle inflammatory response to thigh muscle (quadriceps) eccentric muscle actions. Eccentric muscle actions occur when the muscle is lengthening as it contracts. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle
- What is being tested?
- Eccentric resistance-exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2024to 1 Nov 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old
- healthy
- recreationally active (>/= 150 minutes of moderate to vigorous physical activity per week for at least the past three months)
Who cannot join
- "yes" answer to the Get Active Questionnaire which screens for health conditions that may affect exercise ability
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Applied Research Centre, Faculty of Kinesiology, University of Manitoba
Winnipeg, Manitoba, R3T2N2
Stephen M Cornish, Ph.D., 204-474-9981, Stephen.Cornish@umnaitoba.ca
Zach Henderson, M.Sc., 204-474-7858, zachariah.henderson@umanitoba.ca
About this study
The purpose of this study is to evaluate the acute local skeletal muscle inflammatory response to thigh muscle (quadriceps) eccentric muscle actions. Eccentric muscle actions occur when the muscle is lengthening as it contracts. This is a pilot project to assess the degree of inflammatory biomarkers, called myokines, that are released locally in skeletal muscle tissue after an acute bout of resistance-exercise using a resistance-exercise machine called an isokinetic dynamometer.
Read the detailed description
The intervention will involve one session of maximal eccentric exercise of the knee extensor muscles (quadriceps) of the right leg. During the 24-hour period preceding the intervention, participants will be asked to refrain from any for of moderate-vigorous physical activity or exercise. Participants will perform 30 sets of 10 repetitions of maximal isokinetic eccentric knee extensions at 60 degrees/second with 1-minute of rest between each set. Before completing the exercise bout, each participant will be asked to remain in a seated position (resting) for 30-minutes and then provide a skeletal muscle biopsy using the modified Bergstrom with suction muscle biopsy technique from the vastus lateralis on the right leg. This will be done for the baseline assessment of 5 myokines including apelin, fibroblast growth factor-21, irisin, interleukin-6, and interleukin-15. Then the participants will complete the exercise bout as described above. They will then rest quietly in the laboratory for 3-hours and wait for the second skeletal muscle biopsy to be taken following this 3-hour wait.
- Conditions
- Skeletal Muscle
- Being tested
- Eccentric resistance-exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric resistance-exerciseProcedure or surgery
Each participant will complete 300 repetitions of eccentric knee extensions using an isokinetic dynamometer after a baseline skeletal muscle biopsy is taken. Three hours following this, a second muscle biopsy will be taken to evaluate the changes in the dependent variables being measured (myokines).
| Study group | Role | What they receive |
|---|---|---|
| Eccentric Exercise | Experimental | 300 repetitions of isokinetic dynamometer eccentric knee extensions. Receives: Procedure: Eccentric resistance-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apelin
Concentration of apelin in skeletal muscle tissue
Measured: Baseline and 3-hours post-exercise
Fibroblast growth factor-21
Concentration of fibroblast growth factor-21 in skeletal muscle tissue
Measured: Baseline and 3-hours post-exercise
Irisin
Concentration of irisin in skeletal muscle tissue
Measured: Baseline and 3-hours post-exercise
Interleukin-6
Concentration of interleukin-6 in skeletal muscle tissue
Measured: Baseline and 3-hours post-exercise
Interleukin-15
Concentration of interleukin-15 in skeletal muscle tissue
Measured: Baseline and 3-hours post-exercise
Secondary outcomes (5)
Body mass
Body mass in kilograms
Measured: Baseline
Body height
Body height in meters
Measured: Baseline
Body mass index
Body mass index in kg/m^2
Measured: Baseline
Fat mass
Fat mass in kilograms
Measured: Baseline
Fat free mass
Fat free mass in kilograms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal MuscleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
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
- NCT06677749
- Sponsor's protocol ID
- 60484
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Myokine Response to Acute Eccentric Exercise
- ClinicalTrials.gov ID
- NCT06677749
- Acronym / sponsor ID
- 60484
- Conditions
- Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 7 Nov 2024 (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 purpose of this study is to evaluate the acute local skeletal muscle inflammatory response to thigh muscle (quadriceps) eccentric muscle actions. Eccentric muscle actions occur when the muscle is lengthening as it contracts. This is a pilot project to assess the degree of inflammatory biomarkers, called myokines, that are released locally in skeletal muscle tissue after an acute bout of resistance-exercise using a resistance-exercise machine called an isokinetic dynamometer.
Detailed description
The intervention will involve one session of maximal eccentric exercise of the knee extensor muscles (quadriceps) of the right leg. During the 24-hour period preceding the intervention, participants will be asked to refrain from any for of moderate-vigorous physical activity or exercise. Participants will perform 30 sets of 10 repetitions of maximal isokinetic eccentric knee extensions at 60 degrees/second with 1-minute of rest between each set. Before completing the exercise bout, each participant will be asked to remain in a seated position (resting) for 30-minutes and then provide a skeletal muscle biopsy using the modified Bergstrom with suction muscle biopsy technique from the vastus lateralis on the right leg. This will be done for the baseline assessment of 5 myokines including apelin, fibroblast growth factor-21, irisin, interleukin-6, and interleukin-15. Then the participants will complete the exercise bout as described above. They will then rest quietly in the laboratory for 3-hours and wait for the second skeletal muscle biopsy to be taken following this 3-hour wait.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eccentric Exercise | Experimental | Procedure: Eccentric resistance-exercise300 repetitions of isokinetic dynamometer eccentric knee extensions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-35 years old
- healthy
- recreationally active (>/= 150 minutes of moderate to vigorous physical activity per week for at least the past three months)
Key exclusion criteria (1 listed)
- "yes" answer to the Get Active Questionnaire which screens for health conditions that may affect exercise ability
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 |
|---|---|---|
| Eccentric resistance-exerciseEach participant will complete 300 repetitions of eccentric knee extensions using an isokinetic dynamometer after a baseline skeletal muscle biopsy is taken. Three hours following this, a second muscle biopsy will be taken to evaluate the changes in the dependent variables being measured (myokines). | Procedure or surgery | Eccentric Exercise |
Primary outcome
Apelin
Time frame: Baseline and 3-hours post-exercise
Concentration of apelin in skeletal muscle tissue
Fibroblast growth factor-21
Time frame: Baseline and 3-hours post-exercise
Concentration of fibroblast growth factor-21 in skeletal muscle tissue
Irisin
Time frame: Baseline and 3-hours post-exercise
Concentration of irisin in skeletal muscle tissue
Interleukin-6
Time frame: Baseline and 3-hours post-exercise
Concentration of interleukin-6 in skeletal muscle tissue
Interleukin-15
Time frame: Baseline and 3-hours post-exercise
Concentration of interleukin-15 in skeletal muscle tissue
5 secondary outcomes
Body mass
Time frame: Baseline
Body height
Time frame: Baseline
Body mass index
Time frame: Baseline
Fat mass
Time frame: Baseline
Fat free mass
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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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 Eccentric resistance-exercise in people with Skeletal Muscle, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen M Cornish, PhD (204-381-7296, Stephen.Cornish@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apelin (time frame: Baseline and 3-hours post-exercise). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.