NCT01740661

Brief Summary

The purpose of this study is to determine the immediate effects of cryotherapy on the lower extremity biomechanics during running.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 16, 2014

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

November 20, 2012

Last Update Submit

April 15, 2014

Conditions

Musculoskeletal Injury

Outcome Measures

Primary Outcomes (1)

  • Knee frontal plane moments

    Knee frontal plane loading will be calculated using inverse dynamics based on the ground reaction force data from a force plate and with kinematic data recorded by high speed cameras. Kinematics and kinetics data will be taken during running at 4m/s from each participant prior and after the intervention.

    20 minutes

Study Arms (2)

Cryotherapy

EXPERIMENTAL

The subjects will be exposed to a cold (\~ 12° C) water immersion tub at the umbilical level for 20 minutes.

Other: Cryotherapy

Control

PLACEBO COMPARATOR

The subjects will be exposed to a non-cold (\~ 26° C) water immersion tub at the umbilical level for 20 minutes.

Other: Control

Interventions

CryotherapyOTHER

The subjects will be exposed to a cold (\~ 12° C) water immersion tub at the umbilical level for 20 minutes.

Cryotherapy
ControlOTHER

The subjects will be exposed to a non-cold (\~ 26° C) water immersion tub at the umbilical level for 20 minutes.

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males or females (18 - 40 yrs)
  • no injuries of the lower extremity in the past 6 months prior to participation
  • recreationally active
  • in good health upon entry into the study
  • willing to volunteer for the present project.

You may not qualify if:

  • lower extremity injury within the last 6 months
  • circulatory, vestibular or any contradiction to cryotherapy including Raynaud's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Laboratory, University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc, PT

Study Record Dates

First Submitted

November 20, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

April 16, 2014

Record last verified: 2013-01

Locations

CA(1)