Muscle DamageNCT02280668
Investigating Muscle Repair in Response to Icing Therapy Post Eccentric Muscle Damage Exercise
A study testing Icing Therapy and the eccentric muscle damage exercise in people with Muscle Damage, run by Wilfrid Laurier University at 1 site in Canada.
Trial summary
The purpose of our research is to investigate the effects of applying cold therapy, or "icing," to injured muscles in terms of strength recovery and muscle soreness amelioration following unaccustomed exercise. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Icing Therapy and the eccentric muscle damage exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Apr 2015
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy students attending Wilfrid Laurier University with no previous history of upper body muscle damage and live in close proximity to the University so they can attend all lab sessions. Ideally they have not performed any upper body resistance training within the last 4 months.
Who cannot join
- Previous history of muscle, joint, or ligament injuries in the surrounding area of their dominant are elbow flexor region.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Wilfrid Laurier University
Waterloo, Ontario, N2L 3C5
Peter Tiidus, PhD, 519-884-0710 ext. 3276, ptiidus@wlu.ca
Chris G Chekay
About this study
The purpose of our research is to investigate the effects of applying cold therapy, or "icing," to injured muscles in terms of strength recovery and muscle soreness amelioration following unaccustomed exercise.
Read the detailed description
The objective is to determine whether or not injured muscles that are subject to icing after eccentrically damaging exercise recover their strength quicker and/or have less muscle soreness than those that do not receive any icing treatment after damaging exercise and if any differences in effectiveness between two icing protocols exist. Baseline measures of peak torque of the dominant arm's elbow flexor muscles will be measured by concentric and isometric contractions prior to participants undergoing eccentric muscle damaging exercise. Participants will be randomly assigned into 3 different experimental groups of approximately 15 participants each. The first group will begin "Icing Protocol 1" at time 0 (or as close to). The second group will begin "Icing Protocol 2" six hours after their initial eccentric muscle damaging exercise. The remaining group will not receive any icing treatment; they are the control group. Participants will be brought back into the lab at specific post-exercise times (0h, 24h, 48h, 96h, and 7 days) to complete peak torque measures as they did with baseline measures prior to eccentric muscle damage. Measures of delayed onset muscle soreness (DOMS) will also be taken at baseline and during scheduled follow up times for participants.
- Conditions
- Muscle Damage
- Being tested
- Icing Therapy, the eccentric muscle damage exercise
- Keywords
- muscle, muscle repair, tissue repair, eccentric exercise, force loss, icing, cold therapy, DOMS, soreness, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icing TherapyOther
Also called Cold Therapy, Cryotherapy
Participants will be randomly assigned into 3 experimental groups. Icing Protocol 1 has participants apply cold packs under the supervision of the principal investigators to their elbow flexor region for 10 minutes on, 10 minutes off, followed by an additional 10 minutes on, starting at time 0. Icing Protocol 2 follows the same procedure but it begins 6 hours after the participant has completed their eccentric muscle damaging exercise and is to be done at home without the supervision of the principal investigators. Both protocols require the participants to repeat their icing procedures every 24 hours until their involvement with the study is finished, which is 7 days in duration. The third experimental group is the control group and will not participate in an icing therapy during the duration of the study.
the eccentric muscle damage exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Will perform the eccentric muscle damage exercise and will not perform any icing interventions post damage. These participants will be the control group. Receives: Other: the eccentric muscle damage exercise |
| Icing Protocol 1 | Experimental | Will perform the eccentric muscle damage exercise and will begin the icing intervention immediately after the muscle damage. The icing protocol will be icing the elbow flexor muscles for 10 minutes with a cold pack followed by 10 minutes with no icing and another 10 minutes of elbow flexor muscle icing. The participants will perform this protocol every day at approximately the same time for the duration of the study. Receives: Other: Icing Therapy; Other: the eccentric muscle damage exercise |
| Icing Protocol 2 | Experimental | Will perform the eccentric muscle damage exercise and will begin the icing intervention 6 hours post muscle damage. The icing protocol will be icing the elbow flexor muscles for 10 minutes with a cold pack followed by 10 minutes with no icing and another 10 minutes of elbow flexor muscle icing. The participants will perform this protocol every day at approximately the same time for the duration of the study. Receives: Other: Icing Therapy; Other: the eccentric muscle damage exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak torque strength measures determined using the CYBEX-NORM Testing and Rehabilitation System
Measured: Within 7 days post eccentric muscle damage
Delayed onset muscle soreness determined using the VAS scale of perceived muscle soreness
Measured: Within 7 days post eccentric muscle damage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Chekay, Wilfrid Laurier University
- Investigators
- Peter Tiidus, PhD, Study director, Wilfrid Laurier University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280668
- Sponsor's protocol ID
- 4177
- Status last verified
- Oct 2014
- First submitted
- 29 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Muscle Repair in Response to Icing Therapy Post Eccentric Muscle Damage Exercise
- ClinicalTrials.gov ID
- NCT02280668
- Acronym / sponsor ID
- 4177
- Conditions
- Muscle Damage
- Keywords
- muscle, muscle repair, tissue repair, eccentric exercise, force loss, icing, cold therapy, DOMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 31 Oct 2014 (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.
The purpose of our research is to investigate the effects of applying cold therapy, or "icing," to injured muscles in terms of strength recovery and muscle soreness amelioration following unaccustomed exercise.
Detailed description
The objective is to determine whether or not injured muscles that are subject to icing after eccentrically damaging exercise recover their strength quicker and/or have less muscle soreness than those that do not receive any icing treatment after damaging exercise and if any differences in effectiveness between two icing protocols exist. Baseline measures of peak torque of the dominant arm's elbow flexor muscles will be measured by concentric and isometric contractions prior to participants undergoing eccentric muscle damaging exercise. Participants will be randomly assigned into 3 different experimental groups of approximately 15 participants each. The first group will begin "Icing Protocol 1" at time 0 (or as close to). The second group will begin "Icing Protocol 2" six hours after their initial eccentric muscle damaging exercise. The remaining group will not receive any icing treatment; they are the control group. Participants will be brought back into the lab at specific post-exercise times (0h, 24h, 48h, 96h, and 7 days) to complete peak torque measures as they did with baseline measures prior to eccentric muscle damage. Measures of delayed onset muscle soreness (DOMS) will also be taken at baseline and during scheduled follow up times for participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: the eccentric muscle damage exerciseWill perform the eccentric muscle damage exercise and will not perform any icing interventions post damage. These participants will be the control group. |
| Icing Protocol 1 | Experimental | Other: Icing Therapy, Other: the eccentric muscle damage exerciseWill perform the eccentric muscle damage exercise and will begin the icing intervention immediately after the muscle damage. The icing protocol will be icing the elbow flexor muscles for 10 minutes with a cold pack followed by 10 minutes with no icing and another 10 minutes of elbow flexor muscle icing. The participants will perform this protocol every day at approximately the same time for the duration of the study. |
| Icing Protocol 2 | Experimental | Other: Icing Therapy, Other: the eccentric muscle damage exerciseWill perform the eccentric muscle damage exercise and will begin the icing intervention 6 hours post muscle damage. The icing protocol will be icing the elbow flexor muscles for 10 minutes with a cold pack followed by 10 minutes with no icing and another 10 minutes of elbow flexor muscle icing. The participants will perform this protocol every day at approximately the same time for the duration of the study. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy students attending Wilfrid Laurier University with no previous history of upper body muscle damage and live in close proximity to the University so they can attend all lab sessions. Ideally they have not performed any upper body resistance training within the last 4 months.
Key exclusion criteria (1 listed)
- Previous history of muscle, joint, or ligament injuries in the surrounding area of their dominant are elbow flexor region.
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 |
|---|---|---|
| Icing TherapyAlso: Cold Therapy, CryotherapyParticipants will be randomly assigned into 3 experimental groups. Icing Protocol 1 has participants apply cold packs under the supervision of the principal investigators to their elbow flexor region for 10 minutes on, 10 minutes off, followed by an additional 10 minutes on, starting at time 0. Icing Protocol 2 follows the same procedure but it begins 6 hours after the participant has completed their eccentric muscle damaging exercise and is to be done at home without the supervision of the principal investigators. Both protocols require the participants to repeat their icing procedures every 24 hours until their involvement with the study is finished, which is 7 days in duration. The third experimental group is the control group and will not participate in an icing therapy during the duration of the study. | Other | Icing Protocol 1, Icing Protocol 2 |
| the eccentric muscle damage exercise | Other | Control Group, Icing Protocol 1, Icing Protocol 2 |
Primary outcome
Peak torque strength measures determined using the CYBEX-NORM Testing and Rehabilitation System
Time frame: Within 7 days post eccentric muscle damage
Delayed onset muscle soreness determined using the VAS scale of perceived muscle soreness
Time frame: Within 7 days post eccentric muscle damage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
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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.
Peter Tiidus, PhD study director
Wilfrid Laurier University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Icing Therapy and the eccentric muscle damage exercise in people with Muscle Damage, run by Wilfrid Laurier University 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 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: status not confirmed, as of the sponsor's last update on 31 Oct 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher G Chekay (647-920-6826, chek2690@mylaurier.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak torque strength measures determined using the CYBEX-NORM Testing and Rehabilitation System (time frame: Within 7 days post eccentric muscle damage). 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 31 Oct 2014.