Muscle DamageEIMD-MILKNCT04986150
Sex Differences in Muscle Damage Following Resistance Exercise With or Without Milk Protein Ingestion
A study testing Resistance exercise in people with Muscle Damage, run by Durham University at 1 site in United Kingdom.
Trial summary
Purpose: To investigate the impact of milk protein ingestion on resistance exercise-induced muscle damage in untrained males and females. Rationale: Unaccustomed resistance exercise can cause muscle damage, presenting as muscle soreness and reduced muscle function - such as loss of strength, power, and flexibility … Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Resistance exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2021to Sep 2022
- 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
- BMI 18.5 - 25.0 kg/m2
- Untrained in resistance exercise
- No known chronic disease or current acute illness
- No current or recent (past 3 months) musculoskeletal injury
- No frequent use (2x per week for past month) of non-steroidal anti-inflammatory drugs and compliant to abstain from use during experimental period
- No recent or current engagement in massage or cryotherapy and compliant to abstain from use during experimental period
Show all 10Show fewer
- No current use of protein or antioxidant supplements
- Are able to consume dairy products (i.e., not lactose-intolerant or vegan)
- Females will be eumenorrheic (regular menstrual cycle) >12 months
- Absence of pregnancy and breast-feeding
Who cannot join
- Underweight
- Overweight/obese
- Resistance trained
- Current or recent injury
- Pregnancy or breast-feeding
- Lactose intolerant
- Unwilling to provide blood samples, perform resistance exercise, or abstain from use of NSAID's and protein supplementation (unless instructed as part of the research)
- Unwilling to abstain from other forms of exercise during the experimental period
Trial locations and contacts
1 site in 1 country.
Lindsay S Macnaughton contact
United Kingdom1 site, 1 recruiting
- Recruiting
Durham University, Sports and Wellbeing Park
Durham, DH1 3HN
Alice G Pearson, 07771357222, alice.g.pearson@durham.ac.uk
Lindsay S Macnaughton, lindsay.s.macnaughton@durham.ac.uk
About this study
Official title: Sex Differences in Resistance Exercise-induced Muscle Damage: The Impact of Milk Protein Ingestion
Purpose: To investigate the impact of milk protein ingestion on resistance exercise-induced muscle damage in untrained males and females.
Rationale: Unaccustomed resistance exercise can cause muscle damage, presenting as muscle soreness and reduced muscle function - such as loss of strength, power, and flexibility - for several days after the exercise bout. Therefore, individuals may require longer recovery periods before performing another exercise bout, and their performance may be impaired. Further, muscle soreness may reduce exercise compliance, particularly in novice individuals. Over time, this may compromise the gains in muscle mass and strength achieved through exercise training. Therefore, strategies to reduce the severity of exercise-induced muscle damage and/or to enhance post-exercise recovery processes are advantageous for exercising individuals.
Read more
One such strategy is the consumption of dietary protein before or after muscle-damaging exercise, which has shown to alleviate muscle soreness, improve blood markers of muscle damage, and reduce the decline in maximal force and flexibility. In particular, consuming 20-gram doses of milk protein in the days after resistance exercise can improve the recovery time of muscle soreness and maximum force, and also lower levels of damage markers in the blood. However, most studies have been conducted with male participants who are well-trained in resistance exercise. It has been suggested that males and females respond differently to muscle damage, and therefore, this research aims to provide a sex comparison in the muscle damage response to an acute bout of resistance exercise with or without milk protein feeding.
Therefore, 40 healthy, young (18-35 years) adults (20 males, 20 females) will be recruited to participate in this randomised controlled trial. Maximal leg strength and body composition (by dual-energy X-ray absorptiometry; DXA) will be conducted at baseline. In females, all primary outcome measures will be obtained during the late follicular phase of the menstrual cycle. Participants will then be randomised to a protein (dairy yoghurt) or placebo (oat-based yoghurt) dietary condition.
Three weeks later, participants will complete a high-intensity resistance exercise session on leg extension and leg curl machines to induce muscle damage. Various measures of muscle damage (blood biomarkers, muscle soreness, flexibility, and swelling) will be obtained before, immediately after, and 24, 48, 72, and 168 h after the exercise protocol. The maximal strength test will be repeated 72 and 168 h after the exercise. Participants will consume the protein or placebo yoghurt 4 times per day (every 3-4 hours) on the day of the exercise bout and the following 3 days. Participants' habitual activity and dietary intake will be monitored and controlled throughout the study period.
Expected outcome: It is expected that the resistance exercise protocol will induce muscle damage, which will be attenuated with the ingestion of milk protein. It cannot be ascertained whether males and females will have the same responses to the exercise or to protein ingestion.
- Conditions
- Muscle Damage
- Being tested
- Resistance exercise
- Keywords
- Exercise-induced muscle damage, Resistance exercise, Sex differences, Muscle soreness, Milk protein, Dietary protein
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
Acute leg-based resistance exercise bout performed at 80% 1RM (4 sets to volitional failure on leg extension and leg curl machines)
| Study group | Role | What they receive |
|---|---|---|
| Milk Protein | Experimental | 4 daily 20-gram doses of milk protein (dairy yoghurt) consumed for 4 consecutive days after the exercise bout Receives: Other: Resistance exercise |
| Placebo | Placebo comparator | 4 daily doses of low-protein placebo product (oat-based yoghurt) consumed for 4 consecutive days after the exercise bout Receives: Other: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Voluntary Contraction at baseline
One-repetition maximum (1RM) test: leg extension and leg curl machines
Measured: Baseline
Change from baseline Maximal Voluntary Contraction at 72-hours post-exercise
One-repetition maximum (1RM) test: leg extension and leg curl machines
Measured: 72-hours after the exercise bout
Change from baseline Maximal Voluntary Contraction at 168-hours post-exercise
One-repetition maximum (1RM) test: leg extension and leg curl machines
Measured: 168-hours after the exercise bout
Creatine kinase concentration at baseline
Serum concentration of creatine kinase from venous blood sampling
Measured: Immediately pre-exercise
Change from baseline in Creatine Kinase concentration immediately post-exercise
Serum concentration of creatine kinase from venous blood sampling
Measured: Immediately after the exercise bout
Change from baseline in Creatine Kinase concentration at 24-hours post-exercise
Serum concentration of creatine kinase from venous blood sampling
Measured: 24-hours after the exercise bout
Change from baseline in Creatine Kinase concentration at 48-hours post-exercise
Serum concentration of creatine kinase from venous blood sampling
Measured: 48-hours after the exercise bout
Change from baseline in Creatine Kinase concentration at 72-hours post-exercise
Serum concentration of creatine kinase from venous blood sampling
Measured: 72-hours after the exercise bout
Change from baseline in Creatine Kinase concentration at 168-hours post-exercise
Serum concentration of creatine kinase from venous blood sampling
Measured: 168-hours after the exercise bout
Interleukin-6 concentration at baseline
Serum concentration of Interleukin-6 from venous blood sampling
Measured: Immediately pre-exercise
Change from baseline in Interleukin-6 concentration immediately post-exercise
Serum concentration of Interleukin-6 from venous blood sampling
Measured: Immediately after the exercise bout
Change from baseline in Interleukin-6 concentration at 24-hours post-exercise
Serum concentration of Interleukin-6 from venous blood sampling
Measured: 24-hours after the exercise bout
Change from baseline in Interleukin-6 concentration at 48-hours post-exercise
Serum concentration of Interleukin-6 from venous blood sampling
Measured: 48-hours after the exercise bout
Change from baseline in Interleukin-6 concentration at 72-hours post-exercise
Serum concentration of Interleukin-6 from venous blood sampling
Measured: 72-hours after the exercise bout
Change from baseline in Interleukin-6 concentration at 168-hours post-exercise
Serum concentration of Interleukin-6 from venous blood sampling
Measured: 168-hours after the exercise bout
Muscle soreness (pressure algometry) at baseline
Self-perceived rating of muscle soreness with use of pressure algometry
Measured: Immediately pre-exercise
Change in muscle soreness (pressure algometry) immediately post-exercise
Self-perceived rating of muscle soreness with use of pressure algometry
Measured: Immediately after the exercise bout
Change in muscle soreness (pressure algometry) at 24-hours post-exercise
Self-perceived rating of muscle soreness with use of pressure algometry
Measured: 24-hours after the exercise bout
Change in muscle soreness (pressure algometry) at 48-hours post-exercise
Self-perceived rating of muscle soreness with use of pressure algometry
Measured: 48-hours after the exercise bout
Change in muscle soreness (pressure algometry) at 72-hours post-exercise
Self-perceived rating of muscle soreness with use of pressure algometry
Measured: 72-hours after the exercise bout
Change in muscle soreness (pressure algometry) at 168-hours post-exercise
Self-perceived rating of muscle soreness with use of pressure algometry
Measured: 168-hours after the exercise bout
Muscle soreness (VAS) at baseline
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Measured: Immediately pre-exercise
Change in muscle soreness (VAS) immediately post-exercise
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Measured: Immediately after the exercise bout
Change in muscle soreness (VAS) at 24-hours post-exercise
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Measured: 24-hours after the exercise bout
Change in muscle soreness (VAS) at 48-hours post-exercise
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Measured: 48-hours after the exercise bout
Change in muscle soreness (VAS) at 72-hours post-exercise
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Measured: 72-hours after the exercise bout
Change in muscle soreness (VAS) at 168-hours post-exercise
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Measured: 168-hours after the exercise bout
Range of motion at baseline
Flexibility of the exercised limb as determined by goniometry
Measured: Immediately pre-exercise
Change in range of motion immediately post-exercise
Flexibility of the exercised limb as determined by goniometry
Measured: Immediately after the exercise bout
Change in range of motion at 24-hours post-exercise
Flexibility of the exercised limb as determined by goniometry
Measured: 24-hours after the exercise bout
Change in range of motion at 48-hours post-exercise
Flexibility of the exercised limb as determined by goniometry
Measured: 48-hours after the exercise bout
Change in range of motion at 72-hours post-exercise
Flexibility of the exercised limb as determined by goniometry
Measured: 72-hours after the exercise bout
Change in range of motion at 168-hours post-exercise
Flexibility of the exercised limb as determined by goniometry
Measured: 168-hours after the exercise bout
Limb circumference at baseline
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Measured: Immediately pre-exercise
Change in limb circumference immediately post-exercise
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Measured: Immediately after the exercise bout
Change in limb circumference at 24-hours post-exercise
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Measured: 24-hours after the exercise bout
Change in limb circumference at 48-hours post-exercise
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Measured: 48-hours after the exercise bout
Change in limb circumference at 72-hours post-exercise
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Measured: 72-hours after the exercise bout
Change in limb circumference at 168-hours post-exercise
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Measured: 168-hours after the exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start31 Aug 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Durham University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Pearson, Durham University
- Investigators
- Alice G Pearson, Principal investigator, Durham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986150
- Sponsor's protocol ID
- 290580A
- Acronym
- EIMD-MILK
- Status last verified
- Oct 2021
- First submitted
- 30 Jun 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Resistance Exercise-induced Muscle Damage: The Impact of Milk Protein Ingestion
- ClinicalTrials.gov ID
- NCT04986150
- Acronym / sponsor ID
- EIMD-MILK / 290580A
- Conditions
- Muscle Damage
- Keywords
- Exercise-induced muscle damage, Resistance exercise, Sex differences, Muscle soreness, Milk protein, Dietary protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Durham UniversityUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 2 Aug 2021 (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.
Purpose: To investigate the impact of milk protein ingestion on resistance exercise-induced muscle damage in untrained males and females.
Rationale: Unaccustomed resistance exercise can cause muscle damage, presenting as muscle soreness and reduced muscle function - such as loss of strength, power, and flexibility - for several days after the exercise bout. Therefore, individuals may require longer recovery periods before performing another exercise bout, and their performance may be impaired. Further, muscle soreness may reduce exercise compliance, particularly in novice individuals. Over time, this may compromise the gains in muscle mass and strength achieved through exercise training. Therefore, strategies to reduce the severity of exercise-induced muscle damage and/or to enhance post-exercise recovery processes are advantageous for exercising individuals.
One such strategy is the consumption of dietary protein before or after muscle-damaging exercise, which has shown to alleviate muscle soreness, improve blood markers of muscle damage, and reduce the decline in maximal force and flexibility. In particular, consuming 20-gram doses of milk protein in the days after resistance exercise can improve the recovery time of muscle soreness and maximum force, and also lower levels of damage markers in the blood. However, most studies have been conducted with male participants who are well-trained in resistance exercise. It has been suggested that males and females respond differently to muscle damage, and therefore, this research aims to provide a sex comparison in the muscle damage response to an acute bout of resistance exercise with or without milk protein feeding.
Therefore, 40 healthy, young (18-35 years) adults (20 males, 20 females) will be recruited to participate in this randomised controlled trial. Maximal leg strength and body composition (by dual-energy X-ray absorptiometry; DXA) will be conducted at baseline. In females, all primary outcome measures will be obtained during the late follicular phase of the menstrual cycle. Participants will then be randomised to a protein (dairy yoghurt) or placebo (oat-based yoghurt) dietary condition.
Three weeks later, participants will complete a high-intensity resistance exercise session on leg extension and leg curl machines to induce muscle damage. Various measures of muscle damage (blood biomarkers, muscle soreness, flexibility, and swelling) will be obtained before, immediately after, and 24, 48, 72, and 168 h after the exercise protocol. The maximal strength test will be repeated 72 and 168 h after the exercise. Participants will consume the protein or placebo yoghurt 4 times per day (every 3-4 hours) on the day of the exercise bout and the following 3 days. Participants' habitual activity and dietary intake will be monitored and controlled throughout the study period.
Expected outcome: It is expected that the resistance exercise protocol will induce muscle damage, which will be attenuated with the ingestion of milk protein. It cannot be ascertained whether males and females will have the same responses to the exercise or to protein ingestion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk Protein | Experimental | Other: Resistance exercise4 daily 20-gram doses of milk protein (dairy yoghurt) consumed for 4 consecutive days after the exercise bout |
| Placebo | Placebo comparator | Other: Resistance exercise4 daily doses of low-protein placebo product (oat-based yoghurt) consumed for 4 consecutive days after the exercise bout |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- BMI 18.5 - 25.0 kg/m2
- Untrained in resistance exercise
- No known chronic disease or current acute illness
- No current or recent (past 3 months) musculoskeletal injury
- No frequent use (2x per week for past month) of non-steroidal anti-inflammatory drugs and compliant to abstain from use during experimental period
Key exclusion criteria (8 listed)
- Underweight
- Overweight/obese
- Resistance trained
- Current or recent injury
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Resistance exerciseAcute leg-based resistance exercise bout performed at 80% 1RM (4 sets to volitional failure on leg extension and leg curl machines) | Other | Milk Protein, Placebo |
Primary outcome
Maximal Voluntary Contraction at baseline
Time frame: Baseline
One-repetition maximum (1RM) test: leg extension and leg curl machines
Change from baseline Maximal Voluntary Contraction at 72-hours post-exercise
Time frame: 72-hours after the exercise bout
One-repetition maximum (1RM) test: leg extension and leg curl machines
Change from baseline Maximal Voluntary Contraction at 168-hours post-exercise
Time frame: 168-hours after the exercise bout
One-repetition maximum (1RM) test: leg extension and leg curl machines
Creatine kinase concentration at baseline
Time frame: Immediately pre-exercise
Serum concentration of creatine kinase from venous blood sampling
Change from baseline in Creatine Kinase concentration immediately post-exercise
Time frame: Immediately after the exercise bout
Serum concentration of creatine kinase from venous blood sampling
Change from baseline in Creatine Kinase concentration at 24-hours post-exercise
Time frame: 24-hours after the exercise bout
Serum concentration of creatine kinase from venous blood sampling
Change from baseline in Creatine Kinase concentration at 48-hours post-exercise
Time frame: 48-hours after the exercise bout
Serum concentration of creatine kinase from venous blood sampling
Change from baseline in Creatine Kinase concentration at 72-hours post-exercise
Time frame: 72-hours after the exercise bout
Serum concentration of creatine kinase from venous blood sampling
Change from baseline in Creatine Kinase concentration at 168-hours post-exercise
Time frame: 168-hours after the exercise bout
Serum concentration of creatine kinase from venous blood sampling
Interleukin-6 concentration at baseline
Time frame: Immediately pre-exercise
Serum concentration of Interleukin-6 from venous blood sampling
Change from baseline in Interleukin-6 concentration immediately post-exercise
Time frame: Immediately after the exercise bout
Serum concentration of Interleukin-6 from venous blood sampling
Change from baseline in Interleukin-6 concentration at 24-hours post-exercise
Time frame: 24-hours after the exercise bout
Serum concentration of Interleukin-6 from venous blood sampling
Change from baseline in Interleukin-6 concentration at 48-hours post-exercise
Time frame: 48-hours after the exercise bout
Serum concentration of Interleukin-6 from venous blood sampling
Change from baseline in Interleukin-6 concentration at 72-hours post-exercise
Time frame: 72-hours after the exercise bout
Serum concentration of Interleukin-6 from venous blood sampling
Change from baseline in Interleukin-6 concentration at 168-hours post-exercise
Time frame: 168-hours after the exercise bout
Serum concentration of Interleukin-6 from venous blood sampling
Muscle soreness (pressure algometry) at baseline
Time frame: Immediately pre-exercise
Self-perceived rating of muscle soreness with use of pressure algometry
Change in muscle soreness (pressure algometry) immediately post-exercise
Time frame: Immediately after the exercise bout
Self-perceived rating of muscle soreness with use of pressure algometry
Change in muscle soreness (pressure algometry) at 24-hours post-exercise
Time frame: 24-hours after the exercise bout
Self-perceived rating of muscle soreness with use of pressure algometry
Change in muscle soreness (pressure algometry) at 48-hours post-exercise
Time frame: 48-hours after the exercise bout
Self-perceived rating of muscle soreness with use of pressure algometry
Change in muscle soreness (pressure algometry) at 72-hours post-exercise
Time frame: 72-hours after the exercise bout
Self-perceived rating of muscle soreness with use of pressure algometry
Change in muscle soreness (pressure algometry) at 168-hours post-exercise
Time frame: 168-hours after the exercise bout
Self-perceived rating of muscle soreness with use of pressure algometry
Muscle soreness (VAS) at baseline
Time frame: Immediately pre-exercise
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Change in muscle soreness (VAS) immediately post-exercise
Time frame: Immediately after the exercise bout
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Change in muscle soreness (VAS) at 24-hours post-exercise
Time frame: 24-hours after the exercise bout
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Change in muscle soreness (VAS) at 48-hours post-exercise
Time frame: 48-hours after the exercise bout
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Change in muscle soreness (VAS) at 72-hours post-exercise
Time frame: 72-hours after the exercise bout
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Change in muscle soreness (VAS) at 168-hours post-exercise
Time frame: 168-hours after the exercise bout
Self-perceived rating of muscle soreness while performing a bodyweight squat with use of a visual analogue scale
Range of motion at baseline
Time frame: Immediately pre-exercise
Flexibility of the exercised limb as determined by goniometry
Change in range of motion immediately post-exercise
Time frame: Immediately after the exercise bout
Flexibility of the exercised limb as determined by goniometry
Change in range of motion at 24-hours post-exercise
Time frame: 24-hours after the exercise bout
Flexibility of the exercised limb as determined by goniometry
Change in range of motion at 48-hours post-exercise
Time frame: 48-hours after the exercise bout
Flexibility of the exercised limb as determined by goniometry
Change in range of motion at 72-hours post-exercise
Time frame: 72-hours after the exercise bout
Flexibility of the exercised limb as determined by goniometry
Change in range of motion at 168-hours post-exercise
Time frame: 168-hours after the exercise bout
Flexibility of the exercised limb as determined by goniometry
Limb circumference at baseline
Time frame: Immediately pre-exercise
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Change in limb circumference immediately post-exercise
Time frame: Immediately after the exercise bout
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Change in limb circumference at 24-hours post-exercise
Time frame: 24-hours after the exercise bout
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Change in limb circumference at 48-hours post-exercise
Time frame: 48-hours after the exercise bout
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Change in limb circumference at 72-hours post-exercise
Time frame: 72-hours after the exercise bout
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Change in limb circumference at 168-hours post-exercise
Time frame: 168-hours after the exercise bout
Measure of leg circumference with use of standard anthropometric tape to indicate muscle swelling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
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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.
Lindsay S Macnaughton contact
Alice G Pearson principal investigator
Durham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Muscle Damage, run by Durham University at 1 site in United Kingdom.
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 10 inclusion and 8 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 27 Oct 2021. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 Alice G Pearson (07771357222, alice.g.pearson@durham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Voluntary Contraction at baseline (time frame: Baseline). The study lists 39 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 27 Oct 2021.