NCT03094689

Brief Summary

Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical, biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners. Materials and Methods: This is a randomized, blinded trial in which 30 subjects, 10 km street runners, were randomly divided into three groups: control (gC), immersion (gI) and CWI (gCWI). The runners will be evaluated for clinical (subjective perception of exertion), biochemical (serum CK), functional (unipodal triple hop distance and shuttle test time) and neuromuscular variables by means of isokinetic variables (peak torque, total work and fatigue index). Volunteers will perform pre-assessment, immediately post-race and post-intervention, and 24-hour post-intervention. The data will be expressed by mean and standard deviation, analyzed in the statistical package SPSS 20.0. A significance level of 5% and a 95% confidence interval will be considered for all measures.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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

January 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

January 5, 2017

Last Update Submit

April 27, 2017

Conditions

Keywords

Physical activityMuscle painCryotherapy

Outcome Measures

Primary Outcomes (1)

  • Subjective perception of pain.

    The subjective perception of pain will be measured by means of the visual analogic scale based on the self-report of the level of pain.

    Up to 10 weeks

Study Arms (3)

Control group

NO INTERVENTION

Immersion group

EXPERIMENTAL

They will be immersed in a barrel of 200 liters of water (without ice) at room temperature, according to local conditions of temperature and humidity (Natal county - RN). They will be immersed to the height of the iliac crests for 10 minutes.

Other: Water immersion

Cold water immersion group

EXPERIMENTAL

They will be immersed in a barrel of 200 liters of ice water at an average temperature of 10 ° C for 10 minutes. They will be immersed to the height of the iliac crests.

Other: Cold water immersion

Interventions

Cold water immersion group
Immersion group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index between 18.5 and 30 kg/m2;
  • Street runners for at least 6 months;
  • Week frequency of at least 3 times;
  • Do not present cardiopathies, muscles and neurological diseases;

You may not qualify if:

  • Hypersensitivity or allergies to cryotherapy;
  • Unable to complete the 10 km event on the day of the evaluation;
  • Do not complete or perform any of the study procedures for any reason (phobias, do not withstand the exposure time).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health BehaviorMotor ActivityMyalgia

Condition Hierarchy (Ancestors)

BehaviorMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 5, 2017

First Posted

March 29, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04