Exercise Induced Muscle DamageWIONCT06810271
Walk It Off! the Influence of Physical Activity Level on the Recovery from Damaging Resistance Exercise
A study testing Eccentric resistance exercise in people with Exercise Induced Muscle Damage and Physical Activity, run by University of Toronto at 1 site in Canada.
Trial summary
After completing novel activity or exercise we may experience exercise-induced muscle damage (EIMD), resulting in a period of reduced muscle function and delayed onset muscle soreness (DOMS). DOMS is characterized by muscle pain and tenderness that typically resolves within a week. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Muscle Damage, Physical Activity, Inflammation
- What is being tested?
- Eccentric resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy, recreationally active male and female participants (i.e., weekly MET-minutes > 3000 assessed by International Physical Activity Questionnaire).
- Not having a health condition that would compromise their ability to safely participate in the strenuous physical activity involved in our study screened for by the get active questionnaire.
- Between 18 and 35 years old.
- Body mass index (BMI) between 18.5-30
- Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
- Willing to abide by the compliance rules of this study.
- Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).
Who cannot join
- Inability to adhere to any of the compliance rules judged by the principal investigator or medical doctor.
- Self-reported regular tobacco use.
- Regular use of non-steroidal anti-inflammatory drugs (e.g., Advil)
- Use of oral contraceptives (female participants).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Center for High Performance Sport
Toronto, Ontario, M5S2C9
About this study
After completing novel activity or exercise we may experience exercise-induced muscle damage (EIMD), resulting in a period of reduced muscle function and delayed onset muscle soreness (DOMS). DOMS is characterized by muscle pain and tenderness that typically resolves within a week. While the precise cause of DOMS is unknown, there is growing evidence implicating damage to the connective tissue that surrounds our muscle fibers and is related to a small amount of inflammation. This inflammation is a normal part of our body's ability to recovery from injuries and may be visualized through the use of ultrasound technology. A variety of recovery techniques have been proposed that may help with the recovery of DOMS such as massage and electrical muscle stimulation, but these are not always accessible. Therefore, we are interested in investigating whether the number of daily steps can affect how you experience DOMS.
Read the detailed description
Skeletal muscle pain and tenderness typically follow an unaccustomed bout of physical activity involving eccentric or lengthening contractions. The intensity of pain peaks between 24 and 72 h following the cessation of activity and subsides completely between 5 and 7 days after exercise. Delayed-onset muscle soreness (DOMS) refers to physical discomfort, while associated impairments to muscle strength and function reflect the occurrence of exercise-induced muscle damage (EIMD). The result is reduced performance and increased likelihood of further injury during the affected period. In beginners, DOMS may also reduce the likelihood of continuing exercise.
Despite its ubiquity in sport and exercise, the precise mechanism of DOMS remains uncertain. Potential mechanisms include EIMD, inflammation, and immune cell infiltration among others. More recently, evidence has emerged suggesting a greater role of intramuscular connective tissue damage in causing DOMS. Following an acute bout of eccentric exercise, the fascial connective tissue exhibits greater swelling than after a concentric exercise. Furthermore, this swelling was correlated with the severity of DOMS. This novel evidence may aid in directing strategies to mitigate the duration and severity of DOMS.
A variety of treatments for DOMS have been explored with varying degrees of efficacy. Massage has been shown to effectively mitigate DOMS following exercise as it passively increases muscle blood flow and reduces muscle oedema. Electrostimulation has also been shown to produce analgesic effects following unaccustomed exercise, although results are inconsistent. Differences in the treatment design may produce discrepant findings with longer duration, lower frequency stimulation alleviating DOMS, in contrast to shorter duration, higher frequency stimulation. Furthermore, lower-intensity longer-duration recovery modalities that promote muscle blood flow may partially ameliorate the ergolytic effects of DOMS. Based on these findings, active recovery consisting of low-intensity exercise following training which facilitates muscle blood flow might be expected to improve recovery from DOMS. However, active recovery strategies such as submaximal cycling or jogging following exercise has little effect on recovery from unaccustomed exercise. While these protocols do promote the muscle blood flow in the days following the bout of exercise, their intensity may be too great to allow for recovery of the muscle while their duration may be too low to produce a sustained effect. It has recently been shown that low daily step counts (<5000/day) can interfere with the normal recovery from aerobic exercise and reduce the normal benefits to metabolism, highlighting that our habitual activity levels might be the most important variable in recovering from and adapting to the stress of exercise. Therefore, the purpose of this study is to investigate the effect of high (>10,000 steps) and moderate (<5,000) daily step counts on recovery from an unaccustomed bout of resistance exercise.
- Conditions
- Exercise Induced Muscle Damage, Physical Activity, Inflammation, Exercise Recovery, Skeletal Muscle Damage, Young Adults
- Being tested
- Eccentric resistance exercise
- Keywords
- Resistance exercise, Exercise induced muscle damage, Ultrasound, Subjective pain, Physical activity
- Medical subject headings
- Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric resistance exerciseBehavioural
150 maximal, unilateral eccentric contractions of the quadriceps muscles on a computerized dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| High Activity | Experimental | Requires completion of greater than 10,000 steps per day Receives: Behavioral: Eccentric resistance exercise |
| Moderate Activity | Experimental | Requires completion of less than 5,000 steps per day Receives: Behavioral: Eccentric resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal muscle strength between physical activity levels
Maximal voluntary isometric and isokinetic contraction assessed by peak torque via computerized dynamometer.
Measured: Daily assessment (every 24 hours) across 96 hours post-exercise
Secondary outcomes (2)
Delayed onset muscle soreness (DOMS)
Assessing DOMS by subjective pain assessments using a 10 centimetre visual analog scale following standardized movements (i.e., descend/ascend stairs, sit-to-stand), where a minimum of "0" reflects no pain, and maximum of "10" reflects the most pain imaginable. Units will be reported to the nearest millimetre.
Measured: Daily assessments (every 24 hours) across 96 hours post-exercise
Change in muscle and fascial connective tissue thickness
Assessing changes in vastus lateralis and rectus femoris muscle and fascial connective tissue thickness via ultrasonography.
Measured: Daily assessment (every 24 hours) across 96 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start24 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced Muscle DamageStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study includes a behavioural intervention of high and moderate physical activity, modelled by step counts, as a "treatment", or method to improve recovery from the exercise-induced muscle damage intervention occurring in both high and moderate activity phases.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810271
- Sponsor's protocol ID
- WIO
- Other IDs
- 00045256
- Acronym
- WIO
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 5 Feb 2025
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk It Off! the Influence of Physical Activity Level on the Recovery from Damaging Resistance Exercise
- ClinicalTrials.gov ID
- NCT06810271
- Acronym / sponsor ID
- WIO / WIO
- Conditions
- Exercise Induced Muscle Damage, Physical Activity, Inflammation, Exercise Recovery, Skeletal Muscle Damage, Young Adults
- Keywords
- Resistance exercise, Exercise induced muscle damage, Ultrasound, Subjective pain, Physical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Feb 2025 (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.
After completing novel activity or exercise we may experience exercise-induced muscle damage (EIMD), resulting in a period of reduced muscle function and delayed onset muscle soreness (DOMS). DOMS is characterized by muscle pain and tenderness that typically resolves within a week. While the precise cause of DOMS is unknown, there is growing evidence implicating damage to the connective tissue that surrounds our muscle fibers and is related to a small amount of inflammation. This inflammation is a normal part of our body's ability to recovery from injuries and may be visualized through the use of ultrasound technology. A variety of recovery techniques have been proposed that may help with the recovery of DOMS such as massage and electrical muscle stimulation, but these are not always accessible. Therefore, we are interested in investigating whether the number of daily steps can affect how you experience DOMS.
Detailed description
Skeletal muscle pain and tenderness typically follow an unaccustomed bout of physical activity involving eccentric or lengthening contractions. The intensity of pain peaks between 24 and 72 h following the cessation of activity and subsides completely between 5 and 7 days after exercise. Delayed-onset muscle soreness (DOMS) refers to physical discomfort, while associated impairments to muscle strength and function reflect the occurrence of exercise-induced muscle damage (EIMD). The result is reduced performance and increased likelihood of further injury during the affected period. In beginners, DOMS may also reduce the likelihood of continuing exercise.
Despite its ubiquity in sport and exercise, the precise mechanism of DOMS remains uncertain. Potential mechanisms include EIMD, inflammation, and immune cell infiltration among others. More recently, evidence has emerged suggesting a greater role of intramuscular connective tissue damage in causing DOMS. Following an acute bout of eccentric exercise, the fascial connective tissue exhibits greater swelling than after a concentric exercise. Furthermore, this swelling was correlated with the severity of DOMS. This novel evidence may aid in directing strategies to mitigate the duration and severity of DOMS.
A variety of treatments for DOMS have been explored with varying degrees of efficacy. Massage has been shown to effectively mitigate DOMS following exercise as it passively increases muscle blood flow and reduces muscle oedema. Electrostimulation has also been shown to produce analgesic effects following unaccustomed exercise, although results are inconsistent. Differences in the treatment design may produce discrepant findings with longer duration, lower frequency stimulation alleviating DOMS, in contrast to shorter duration, higher frequency stimulation. Furthermore, lower-intensity longer-duration recovery modalities that promote muscle blood flow may partially ameliorate the ergolytic effects of DOMS. Based on these findings, active recovery consisting of low-intensity exercise following training which facilitates muscle blood flow might be expected to improve recovery from DOMS. However, active recovery strategies such as submaximal cycling or jogging following exercise has little effect on recovery from unaccustomed exercise. While these protocols do promote the muscle blood flow in the days following the bout of exercise, their intensity may be too great to allow for recovery of the muscle while their duration may be too low to produce a sustained effect. It has recently been shown that low daily step counts (<5000/day) can interfere with the normal recovery from aerobic exercise and reduce the normal benefits to metabolism, highlighting that our habitual activity levels might be the most important variable in recovering from and adapting to the stress of exercise. Therefore, the purpose of this study is to investigate the effect of high (>10,000 steps) and moderate (<5,000) daily step counts on recovery from an unaccustomed bout of resistance exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study includes a behavioural intervention of high and moderate physical activity, modelled by step counts, as a "treatment", or method to improve recovery from the exercise-induced muscle damage intervention occurring in both high and moderate activity phases.
| Arm | Type | Receives |
|---|---|---|
| High Activity | Experimental | Behavioral: Eccentric resistance exerciseRequires completion of greater than 10,000 steps per day |
| Moderate Activity | Experimental | Behavioral: Eccentric resistance exerciseRequires completion of less than 5,000 steps per day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, recreationally active male and female participants (i.e., weekly MET-minutes > 3000 assessed by International Physical Activity Questionnaire).
- Not having a health condition that would compromise their ability to safely participate in the strenuous physical activity involved in our study screened for by the get active questionnaire.
- Between 18 and 35 years old.
- Body mass index (BMI) between 18.5-30
- Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
Key exclusion criteria (4 listed)
- Inability to adhere to any of the compliance rules judged by the principal investigator or medical doctor.
- Self-reported regular tobacco use.
- Regular use of non-steroidal anti-inflammatory drugs (e.g., Advil)
- Use of oral contraceptives (female participants).
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 exercise150 maximal, unilateral eccentric contractions of the quadriceps muscles on a computerized dynamometer. | Behavioural | High Activity, Moderate Activity |
Primary outcome
Change in maximal muscle strength between physical activity levels
Time frame: Daily assessment (every 24 hours) across 96 hours post-exercise
Maximal voluntary isometric and isokinetic contraction assessed by peak torque via computerized dynamometer.
2 secondary outcomes
Delayed onset muscle soreness (DOMS)
Time frame: Daily assessments (every 24 hours) across 96 hours post-exercise
Change in muscle and fascial connective tissue thickness
Time frame: Daily assessment (every 24 hours) across 96 hours post-exercise
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exercise Induced Muscle Damage and Physical Activity, run by University of Toronto 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in maximal muscle strength between physical activity levels (time frame: Daily assessment (every 24 hours) across 96 hours post-exercise). 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 5 Feb 2025.