HealthyMORALNCT06638788
Muslce Oxygenation of the Quadricep Relative to Angle and Load
A study testing Knee extension in people with Healthy, run by University of British Columbia.
Trial summary
The purpose of the present study is to determine if the amount of oxygen in muscles during resistance exercise with different weights is related to changes in torque or knee joint angle. Participants will need to come to the lab three times over three weeks. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Knee extension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to Nov 2024
- 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 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and communicate in English
- All "No" answers on the CSEP Get Active questionnaire
Who cannot join
- Current use of cigarettes or other nicotine devices
- Any major uncontrolled cardiovascular, muscular, metabolic, and/or neurological disorders
- Any medical condition impacting the ability to participate in maximal exercise
- Type one or type two diabetes
- Diagnosis of cancer or undergoing cancer treatment in the past 12 months
- Drug therapy with any drugs that alter skeletal muscle metabolism (i.e., Metformin, Benzodiazepines, hormone replacement therapy drugs)
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the present study is to determine if the amount of oxygen in muscles during resistance exercise with different weights is related to changes in torque or knee joint angle. Participants will need to come to the lab three times over three weeks. On their first visit, we will test how strong their muscles are by testing the maximal weight that can be lifted in a single repetition of a knee extension referred to as a 1 repetition maximal (1RM) followed by exercise interventions during the second and third weeks. Each exercise session will have participants lift different amounts of weight. They will use two machines: the Biodex dynamometer, that maintains constant force during a knee extension and a standard weighted knee extension machine which has variable force outputs. Participants will perform these exercises against three levels of weight, making six tests in total. Their first exercise session will take about 70 minutes and the following sessions around 55-60 minutes. They will be provided a 5-minute break between each set of lifts to ensure they are fully rested. In total, participants will be exercising for about 25-30 minutes each visit, with the rest of the time spent resting. The weights will be different percentages of the heaviest weight participants can lift.
Read the detailed description
Visit 1 (70 minutes) Informed Consent and Baseline Testing Session 1
After verbal consent for participation an in-person visit will be scheduled with the associate investigator which will take place in our research space at the Chan Gunn Pavilion.
You will be asked to bring comfortable exercise clothes to this visit.
The consent form will be reviewed with you to ensure you completely understand each aspect of your involvement in the trial. If you wish to participate, you will provide written consent by signing this document in person.
Upon registration into this trial, you will complete the CSEP-Get Active Questionnaire (CSEP-GAQ), in person, which will assess your ability to safely perform exercise, as well as a general activity questionnaire to assess your exercise habits over the past 12-months. The CSEP-GAQ you complete today will be the same as the version used during your initial phone call/email screening with the study coordinator (Jacob Sanders or Ashlesh Mathrani).
Weekly physical activity will also be recorded now.
The exercise training history form will be filled out. This form will ask on average how many lower-body resistance training sets are completed per week, and on average how many minutes of lower-body moderate to vigorous physical activity are completed per week.
You will be asked to refrain from strenuous lower-body exercise for 48 hours or alcohol 12 hours before the visit, and every following visit.
We will then familiarize you with the diet and sleep forms which you will fill out at the start of every exercise intervention visit.
You will also state your dominant leg which will be used for all testing conditions
We will then randomize you to complete either variable load standard knee extensions or constant torque Biodex knee extensions in your second and third visit
You will then also be sequenced to randomly complete 20, 40, and 60% 1RM variable load standard knee extensions or constant torque Biodex knee extensions in visit 2 and 3
Upon completion of the study related forms, and randomization, height and weight will be recorded
Following these recordings, you will perform a one-repetition maximum (1RM) assessment for the knee-extension exercise on your dominant leg. This test involves slowly working up to a weight that you can move for a maximum of one full range of motion repetition.
Following the 1RM assessment, you will perform maximal isokinetic contractions on the Biodex on your dominant leg. This test involves maximum effort knee extensions at a fixed speed. This test is conducted 3 times on your dominant leg with a 2-minute rest in between tests.
Visits 2 and 3 (55/60 minutes each) Exercise Condition Visits
Visits 2 and 3 will involve a standardized warmup, filling out the sleep and diet questionnaires, and the exercise conditions in a random order. You will be asked to bring shorts and your choice of exercise top. The conditions for these visits are listed below:
Knee-extension exercises:
Dominant leg 18 repetitions at 20% 1RM set
Dominant leg 12 repetitions at 40% 1RM set
Dominant leg 6 repetitions at 60% 1RM set
Biodex exercises
Dominant leg 18 repetitions at 20% max torque set
Dominant leg 12 repetitions at 40% max torque set
Dominant leg 6 repetitions at 60% max torque set
You will arrive at the lab and will be fitted with near-infrared oxygen sensors (NIRS) on the outside of your thighs at the bottom 2/3rds between the top of the hip and the knee measuring muscle oxygenation.
You will then undergo calibration of the NIRS sensors by laying face up on a therapy table where we will then calculate your personal tourniquet pressure (PTP) on your dominant leg, a measurement used to determine pressure for a blood pressure cuff specific to your systolic blood pressure, and lower extremity limb occlusion pressure (LOP) which will determine the amount of pressure that is required for full occlusion of the arteries which will involve the cuff inflating and deflating for 20-30 seconds.
120% LOP is being used to ensure arterial flow is completely occluded. You will remain occluded until your oxygen saturation plateaus for 10 seconds (this takes between 3-5 minutes - during this time you may experience coldness/numbness in your leg and if at any point you wish to stop you can inform the research staff and the cuffs will be immediately deflated).
NIRS procedures will be performed by Jacob Sanders or Ashlesh Mathrani with specific experience and training in the procedure. These staff are not necessarily medical professionals, and it is possible that no medical professional will be in the room at the time of the procedure. Dr. Cameron Mitchell has reviewed and continues to review the performance of these procedures.
Following this plateau in saturation, the cuffs will be rapidly deflated, and you will remain face up on the therapy table until your oxygen saturation returns to resting values for two minutes.
You will then perform a general warmup on a stationary bike which will consist of 3-5 minutes of low intensity cycling at a load between 20-50W (this load will be self-selected and recorded during visit 1 and used during visits 2 and 3).
Following the general warmup you will then perform an exercise specific warmup
Six exercise tests will be performed for the variable load knee extension and constant torque Biodex knee extension split evenly with 5 minutes of rest separating sets.
Variable Load Standard Knee Extension
You will perform the knee extension exercises mentioned prior on your dominant leg and subsequently rest for 5-minutes, during which you may sit up from the leg extension machine, walk around, or use your phone/computer.
After 5 minutes of rest, you will perform the next variable load knee extension exercise test condition but this time on the dominant leg, and subsequently rest another 5 minutes.
You will repeat this procedure for the third exercise test condition as well.
All equipment used on these visits will be cleaned with disinfectant wipes before use by the next participant.
Constant Torque Biodex Dynamometer
You will perform constant torque Biodex knee extension exercises mentioned prior on your dominant leg and subsequently rest 5 minutes, during which you may sit up from the Biodex machine, walk around, or use your phone/computer.
After 5 minutes of rest, you will perform the following constant torque Biodex knee extension exercise condition and subsequently rest another 5 minutes.
After 5 minutes of rest, you will repeat the same procedure for the third exercise test condition.
All equipment used in these visits will be cleaned with disinfectant wipes following use and prior to use by the next participant.
- Conditions
- Healthy
- Being tested
- Knee extension
- Keywords
- Muscle Oxygenation, Angle and Muscle Oxygenation, Torque and muscle oxygenation, Knee extension and muscle oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee extensionOther
Participants will perform 20, 40, and 60% of thier 1 rep maximum (1RM) at 18, 12, and 6 reps respectively.
| Study group | Role | What they receive |
|---|---|---|
| Constant Torque Biodex Dynamometer | Experimental | Participants will perform their intervention on the constant torque Biodex Dynamometer Receives: Other: Knee extension |
| Variable Torque Standerd Knee Extension | Experimental | Participants will perform their intervention on the variable torque standerd knee extension machine Receives: Other: Knee extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle oxygenation (SmO2) curve during constant torque knee extension compared to joint angle
Percent of SmO2 dynamic range (%SmO2 max) will be measured during constant torque knee extension conditions at 20, 40, and 60% 1RM at 18, 12, and 6 reps respectively. The SmO2 curve for each sextile of the reps range of motion will be compared to joint angle across the three loads.
Measured: Within 55/60mins testing session during week 2 or 3.
Muscle oxygenation (SmO2) curve during variable torque knee extension compared to torque
Percent of SmO2 dynamic range (%SmO2 max) will be measured during variable torque knee extension conditions at 20, 40, and 60% 1RM at 18, 12, and 6 reps respectively. The SmO2 curve for each sextile of the reps range of motion will be compared to torque across the three loads.
Measured: Within 55/60mins testing session during week 2 or 3.
Secondary outcomes (1)
Muscle oxygenation curve during variable torque compared to constant torque
Muscle oxygenation (%SmO2 max) curve during variable torque knee extension will be compared to the SmO2 curve during constant torque knee extension at 20, 40, 60% 1RM at 18, 12, and 6 reps respectively.
Measured: Within 55/60mins testing session during week 2 or 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 Sep 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Model description
- Participants will be completing loads of 20, 40, and 60% 1RM at 18,12, and 6 reps respectively on the standard knee extension (varying torque) and biodex dynamometer machine (constant torque). The muscle oxygenation of the vastus laterals muscle will be assessed throughout its range of motion in both conditions and compared to torque (standard knee extension) or knee angle (Biodex dynamometer).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron Mitchell, University of British Columbia
- Investigators
- Cameron Mitchell, B.kin, MSc, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638788
- Sponsor's protocol ID
- H24-01632
- Acronym
- MORAL
- Status last verified
- Sep 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muslce Oxygenation of the Quadricep Relative to Angle and Load
- ClinicalTrials.gov ID
- NCT06638788
- Acronym / sponsor ID
- MORAL / H24-01632
- Conditions
- Healthy
- Keywords
- Muscle Oxygenation, Angle and Muscle Oxygenation, Torque and muscle oxygenation, Knee extension and muscle oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 15 Oct 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 the present study is to determine if the amount of oxygen in muscles during resistance exercise with different weights is related to changes in torque or knee joint angle. Participants will need to come to the lab three times over three weeks. On their first visit, we will test how strong their muscles are by testing the maximal weight that can be lifted in a single repetition of a knee extension referred to as a 1 repetition maximal (1RM) followed by exercise interventions during the second and third weeks. Each exercise session will have participants lift different amounts of weight. They will use two machines: the Biodex dynamometer, that maintains constant force during a knee extension and a standard weighted knee extension machine which has variable force outputs. Participants will perform these exercises against three levels of weight, making six tests in total. Their first exercise session will take about 70 minutes and the following sessions around 55-60 minutes. They will be provided a 5-minute break between each set of lifts to ensure they are fully rested. In total, participants will be exercising for about 25-30 minutes each visit, with the rest of the time spent resting. The weights will be different percentages of the heaviest weight participants can lift.
Detailed description
Visit 1 (70 minutes) Informed Consent and Baseline Testing Session 1
After verbal consent for participation an in-person visit will be scheduled with the associate investigator which will take place in our research space at the Chan Gunn Pavilion.
You will be asked to bring comfortable exercise clothes to this visit.
The consent form will be reviewed with you to ensure you completely understand each aspect of your involvement in the trial. If you wish to participate, you will provide written consent by signing this document in person.
Upon registration into this trial, you will complete the CSEP-Get Active Questionnaire (CSEP-GAQ), in person, which will assess your ability to safely perform exercise, as well as a general activity questionnaire to assess your exercise habits over the past 12-months. The CSEP-GAQ you complete today will be the same as the version used during your initial phone call/email screening with the study coordinator (Jacob Sanders or Ashlesh Mathrani).
Weekly physical activity will also be recorded now.
The exercise training history form will be filled out. This form will ask on average how many lower-body resistance training sets are completed per week, and on average how many minutes of lower-body moderate to vigorous physical activity are completed per week.
You will be asked to refrain from strenuous lower-body exercise for 48 hours or alcohol 12 hours before the visit, and every following visit.
We will then familiarize you with the diet and sleep forms which you will fill out at the start of every exercise intervention visit.
You will also state your dominant leg which will be used for all testing conditions
We will then randomize you to complete either variable load standard knee extensions or constant torque Biodex knee extensions in your second and third visit
You will then also be sequenced to randomly complete 20, 40, and 60% 1RM variable load standard knee extensions or constant torque Biodex knee extensions in visit 2 and 3
Upon completion of the study related forms, and randomization, height and weight will be recorded
Following these recordings, you will perform a one-repetition maximum (1RM) assessment for the knee-extension exercise on your dominant leg. This test involves slowly working up to a weight that you can move for a maximum of one full range of motion repetition.
Following the 1RM assessment, you will perform maximal isokinetic contractions on the Biodex on your dominant leg. This test involves maximum effort knee extensions at a fixed speed. This test is conducted 3 times on your dominant leg with a 2-minute rest in between tests.
Visits 2 and 3 (55/60 minutes each) Exercise Condition Visits
Visits 2 and 3 will involve a standardized warmup, filling out the sleep and diet questionnaires, and the exercise conditions in a random order. You will be asked to bring shorts and your choice of exercise top. The conditions for these visits are listed below:
Knee-extension exercises:
Dominant leg 18 repetitions at 20% 1RM set
Dominant leg 12 repetitions at 40% 1RM set
Dominant leg 6 repetitions at 60% 1RM set
Biodex exercises
Dominant leg 18 repetitions at 20% max torque set
Dominant leg 12 repetitions at 40% max torque set
Dominant leg 6 repetitions at 60% max torque set
You will arrive at the lab and will be fitted with near-infrared oxygen sensors (NIRS) on the outside of your thighs at the bottom 2/3rds between the top of the hip and the knee measuring muscle oxygenation.
You will then undergo calibration of the NIRS sensors by laying face up on a therapy table where we will then calculate your personal tourniquet pressure (PTP) on your dominant leg, a measurement used to determine pressure for a blood pressure cuff specific to your systolic blood pressure, and lower extremity limb occlusion pressure (LOP) which will determine the amount of pressure that is required for full occlusion of the arteries which will involve the cuff inflating and deflating for 20-30 seconds.
120% LOP is being used to ensure arterial flow is completely occluded. You will remain occluded until your oxygen saturation plateaus for 10 seconds (this takes between 3-5 minutes - during this time you may experience coldness/numbness in your leg and if at any point you wish to stop you can inform the research staff and the cuffs will be immediately deflated).
NIRS procedures will be performed by Jacob Sanders or Ashlesh Mathrani with specific experience and training in the procedure. These staff are not necessarily medical professionals, and it is possible that no medical professional will be in the room at the time of the procedure. Dr. Cameron Mitchell has reviewed and continues to review the performance of these procedures.
Following this plateau in saturation, the cuffs will be rapidly deflated, and you will remain face up on the therapy table until your oxygen saturation returns to resting values for two minutes.
You will then perform a general warmup on a stationary bike which will consist of 3-5 minutes of low intensity cycling at a load between 20-50W (this load will be self-selected and recorded during visit 1 and used during visits 2 and 3).
Following the general warmup you will then perform an exercise specific warmup
Six exercise tests will be performed for the variable load knee extension and constant torque Biodex knee extension split evenly with 5 minutes of rest separating sets.
Variable Load Standard Knee Extension
You will perform the knee extension exercises mentioned prior on your dominant leg and subsequently rest for 5-minutes, during which you may sit up from the leg extension machine, walk around, or use your phone/computer.
After 5 minutes of rest, you will perform the next variable load knee extension exercise test condition but this time on the dominant leg, and subsequently rest another 5 minutes.
You will repeat this procedure for the third exercise test condition as well.
All equipment used on these visits will be cleaned with disinfectant wipes before use by the next participant.
Constant Torque Biodex Dynamometer
You will perform constant torque Biodex knee extension exercises mentioned prior on your dominant leg and subsequently rest 5 minutes, during which you may sit up from the Biodex machine, walk around, or use your phone/computer.
After 5 minutes of rest, you will perform the following constant torque Biodex knee extension exercise condition and subsequently rest another 5 minutes.
After 5 minutes of rest, you will repeat the same procedure for the third exercise test condition.
All equipment used in these visits will be cleaned with disinfectant wipes following use and prior to use by the next participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be completing loads of 20, 40, and 60% 1RM at 18,12, and 6 reps respectively on the standard knee extension (varying torque) and biodex dynamometer machine (constant torque). The muscle oxygenation of the vastus laterals muscle will be assessed throughout its range of motion in both conditions and compared to torque (standard knee extension) or knee angle (Biodex dynamometer).
| Arm | Type | Receives |
|---|---|---|
| Constant Torque Biodex Dynamometer | Experimental | Other: Knee extensionParticipants will perform their intervention on the constant torque Biodex Dynamometer |
| Variable Torque Standerd Knee Extension | Experimental | Other: Knee extensionParticipants will perform their intervention on the variable torque standerd knee extension machine |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Able to understand and communicate in English
- All "No" answers on the CSEP Get Active questionnaire
Key exclusion criteria (6 listed)
- Current use of cigarettes or other nicotine devices
- Any major uncontrolled cardiovascular, muscular, metabolic, and/or neurological disorders
- Any medical condition impacting the ability to participate in maximal exercise
- Type one or type two diabetes
- Diagnosis of cancer or undergoing cancer treatment in the past 12 months
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 |
|---|---|---|
| Knee extensionParticipants will perform 20, 40, and 60% of thier 1 rep maximum (1RM) at 18, 12, and 6 reps respectively. | Other | Constant Torque Biodex Dynamometer, Variable Torque Standerd Knee Extension |
Primary outcome
Muscle oxygenation (SmO2) curve during constant torque knee extension compared to joint angle
Time frame: Within 55/60mins testing session during week 2 or 3.
Percent of SmO2 dynamic range (%SmO2 max) will be measured during constant torque knee extension conditions at 20, 40, and 60% 1RM at 18, 12, and 6 reps respectively. The SmO2 curve for each sextile of the reps range of motion will be compared to joint angle across the three loads.
Muscle oxygenation (SmO2) curve during variable torque knee extension compared to torque
Time frame: Within 55/60mins testing session during week 2 or 3.
Percent of SmO2 dynamic range (%SmO2 max) will be measured during variable torque knee extension conditions at 20, 40, and 60% 1RM at 18, 12, and 6 reps respectively. The SmO2 curve for each sextile of the reps range of motion will be compared to torque across the three loads.
1 secondary outcome
Muscle oxygenation curve during variable torque compared to constant torque
Time frame: Within 55/60mins testing session during week 2 or 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Cameron Mitchell, B.kin, MSc, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Knee extension in people with Healthy, run by University of British Columbia.
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 6 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Cameron Mitchell, B.kin, MSc, PhD (604-827-2072, cameron.mitchell@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle oxygenation (SmO2) curve during constant torque knee extension compared to joint angle (time frame: Within 55/60mins testing session during week 2 or 3.). 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?
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 15 Oct 2024.