Investigating Muscle Repair in Response to Icing Therapy Post Eccentric Muscle Damage Exercise

October 30, 2014 updated by: Christopher Chekay, Wilfrid Laurier University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3C5
        • Recruiting
        • Wilfrid Laurier University
        • Contact:
          • Peter Tiidus, PhD
          • Phone Number: 3276 519-884-0710
          • Email: ptiidus@wlu.ca
        • Principal Investigator:
          • Chris G Chekay
        • Principal Investigator:
          • Justin D White

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Previous history of muscle, joint, or ligament injuries in the surrounding area of their dominant are elbow flexor region.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Will perform the eccentric muscle damage exercise and will not perform any icing interventions post damage. These participants will be the control group.
Other: the eccentric muscle damage exercise
Experimental: Icing Protocol 1
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.
Other: the eccentric muscle damage exercise
Other: Icing Therapy
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.
Other Names:
  • Cryotherapy
  • Cold Therapy
Experimental: Icing Protocol 2
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.
Other: the eccentric muscle damage exercise
Other: Icing Therapy
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.
Other Names:
  • Cryotherapy
  • Cold Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Peak torque strength measures determined using the CYBEX-NORM Testing and Rehabilitation System
Time Frame: Within 7 days post eccentric muscle damage
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
Within 7 days post eccentric muscle damage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wilfrid Laurier University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Peter Tiidus, PhD, Wilfrid Laurier University, Faculty of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4177

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