Exercise-induced Muscle DamageNCT01907841
The Effect of Ischemic Pre-Conditioning on the Rate of Recovery Following Exercise-Induced Muscle Damage
A study testing Ischemic Preconditioning in people with Exercise-induced Muscle Damage, run by St Mary's University College at 1 site in United Kingdom.
Trial summary
Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle damage and changes in muscle function; this is known as exercise-induced muscle damage (EIMD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Muscle Damage
- What is being tested?
- Ischemic Preconditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Nov 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically Active Males
Who cannot join
- Muscular skeletal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ischemic Pre-Conditioning on the Rate of Recovery Following Exercise-Induced Muscle Damage: a Randomized Control Trial
Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle damage and changes in muscle function; this is known as exercise-induced muscle damage (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as in various other organs.
Therefore the purpose of this study is to:
- Quantify the use of IPC in recovery following EIMD.
- Identify any effect of IPC during recovery on muscle function
- Conditions
- Exercise-induced Muscle Damage
- Being tested
- Ischemic Preconditioning
- Keywords
- Investigate IPC on EIMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic PreconditioningOther
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Preconditioning | Experimental | IPC (4 x 5 minute cycles @ 220 mmHg) with 5 min reperfusion between trials. Receives: Other: Ischemic Preconditioning |
| Ischemic Preconditioning Placebo | Placebo comparator | Placebo (4 x 5 minute cycles @ 20mmHg) with 5 minutes between each cycle Receives: Other: Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in maximal voluntary contraction
Isometric MVC of the participants' dominant knee extensors was assessed using a strain gauge. MVCs were performed for 3 s with a 60 s rest between each repetition.
The change in MVC will be determined 24, 48 and 72 hours following pre exercise conditions.
Measured: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Secondary outcomes (4)
Change from baseline in Creatine kinase
Plasma CK was determined from an earlobe capillary blood sample. The sample (10 microlitres) was analysed immediately using an semi-automated clinical chemistry analyser.
The change in CK will be determined 24, 48 and 72 hours following pre exercise conditions
Measured: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Change from baseline in Limb girth
Mid-thigh and calf circumference was assessed as a measure of limb swelling using an anthropometric tape measure. Both measures were obtained with the participant in a standing position.
The change in limb girth will be determined 24, 48 and 72 hours following pre exercise conditions
Measured: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Chnage from baseline in Vertical jump
Vertical jump (VJ) performance was assessed using an electronic timing mat with hands placed on hips and participants dropping down to a self-selected level before jumping maximally.
The change in VJ will be determined 24, 48 and 72 hours following pre exercise conditions
Measured: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Change from baseline in Muscle soreness
Muscle soreness - Participants were asked to perform and hold a squat (90° knee angle) whilst they rated their perceived muscle soreness on a 200 mm visual analogue scale. The scale consisted of a line from 0 mm (no pain) to 200 mm (unbearably painful).
The change in muscle soreness will be determined 24, 48 and 72 hours following pre exercise conditions
Measured: pre exercise, 24 hours post, 48 hours post and 72 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 posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionNov 2013
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Patterson, St Mary's University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907841
- Sponsor's protocol ID
- IPCEIMD001
- Status last verified
- Mar 2014
- First submitted
- 15 Jul 2013
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ischemic Pre-Conditioning on the Rate of Recovery Following Exercise-Induced Muscle Damage: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01907841
- Acronym / sponsor ID
- IPCEIMD001
- Conditions
- Exercise-induced Muscle Damage
- Keywords
- Investigate IPC on EIMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle damage and changes in muscle function; this is known as exercise-induced muscle damage (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as in various other organs.
Therefore the purpose of this study is to:
- Quantify the use of IPC in recovery following EIMD.
- Identify any effect of IPC during recovery on muscle function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Preconditioning | Experimental | Other: Ischemic PreconditioningIPC (4 x 5 minute cycles @ 220 mmHg) with 5 min reperfusion between trials. |
| Ischemic Preconditioning Placebo | Placebo comparator | Other: Ischemic PreconditioningPlacebo (4 x 5 minute cycles @ 20mmHg) with 5 minutes between each cycle |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physically Active Males
Key exclusion criteria (1 listed)
- Muscular skeletal disorders
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 |
|---|---|---|
| Ischemic Preconditioning | Other | Ischemic Preconditioning, Ischemic Preconditioning Placebo |
Primary outcome
Change from baseline in maximal voluntary contraction
Time frame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Isometric MVC of the participants' dominant knee extensors was assessed using a strain gauge. MVCs were performed for 3 s with a 60 s rest between each repetition. The change in MVC will be determined 24, 48 and 72 hours following pre exercise conditions.
4 secondary outcomes
Change from baseline in Creatine kinase
Time frame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Change from baseline in Limb girth
Time frame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Chnage from baseline in Vertical jump
Time frame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Change from baseline in Muscle soreness
Time frame: pre exercise, 24 hours post, 48 hours post and 72 hours post exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
Related trials for Exercise-induced Muscle Damage
Not yet recruiting
Effects of Manual Lymphatic Drainage and Pressotherapy on Muscle Recovery After Eccentric Exercise in Physically Active Young Adults
Young Athletes
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Active, not recruiting
Effects of Nattokinase Supplementation on Strength Recovery and Muscle Damage Biomarkers Following Exercise-Induced Muscle Injury: A Pilot Study
Exercise-induced Muscle Damage
Recruiting
The Effect of Different rTMS Interventions on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia
Insomnia, Healthy Adult
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 Ischemic Preconditioning in people with Exercise-induced Muscle Damage, run by St Mary's University College 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 1 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: finished, as of the sponsor's last update on 6 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in maximal voluntary contraction (time frame: pre exercise, 24 hours post, 48 hours post and 72 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 6 Mar 2014.