NCT02280668

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

October 29, 2014

Last Update Submit

October 30, 2014

Conditions

Keywords

musclemuscle repairtissue repaireccentric exerciseforce lossicingcold therapyDOMSsorenessrecovery

Outcome Measures

Primary Outcomes (2)

  • Peak torque strength measures determined using the CYBEX-NORM Testing and Rehabilitation System

    Within 7 days post eccentric muscle damage

  • Delayed onset muscle soreness determined using the VAS scale of perceived muscle soreness

    Within 7 days post eccentric muscle damage

Study Arms (3)

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.

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.

Other: Icing TherapyOther: 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.

Other: Icing TherapyOther: the eccentric muscle damage exercise

Interventions

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.

Also known as: Cold Therapy, Cryotherapy
Icing Protocol 1Icing Protocol 2
Control GroupIcing Protocol 1Icing Protocol 2

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

RECRUITING

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Peter Tiidus, PhD

    Wilfrid Laurier University, Faculty of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

Christopher G Chekay

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Undergraduate Student

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 31, 2014

Record last verified: 2014-10

Locations