NCT01872091

Brief Summary

Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

3.5 years

First QC Date

May 27, 2013

Last Update Submit

July 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the strength and muscle synergism after cryotherapy immersion

    The objective of this study is to Evaluate the strength and muscle synergism between wrist flexors and extensors after forearm immersion cryotherapy. Testing grip strength will be carried out 3 times in a row, with 4 seconds of maximum voluntary isometric contraction, with a 1 minute interval between them; before, immediately after, 25 minutes and 50 minutes after immersion. Strength evaluation is conducted using a load cell. Concurrent with this test, the signal will be collected electromyographic extensor and flexor wrist, upper and middle trapezius fibers and anterior serratus.

    2 years

Secondary Outcomes (1)

  • Blood flow velocity before and after immersion of the forearm cryotherapy

    2 years

Other Outcomes (1)

  • Changes in skin temperature before and after cryotherapy by immersion of the forearm

    2 years

Study Arms (2)

cryotherapy by immersion

EXPERIMENTAL

Cryotherapy group immersion (GI) composed of 20 volunteers, which will be subjected to immersion cryotherapy upper limb dominant in cold water (6°C ± 2°C), at the level of the elbow joint.

Other: cryotherapy by immersion

Control group

EXPERIMENTAL

(CG) consisted of 20 volunteers, which will be submitted to immersion of the dominant upper limb in water at room temperature indifferent to the level of the elbow joint;

Other: Control group

Interventions

cryotherapy by immersion
Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals, age range: 18 - 30 years old

You may not qualify if:

  • not present: previous circulatory, nervous or metabolic diseases, metal implants in areas to be studied; fracture on upper limb studied; history of pain or injury in the joints studied
  • are not in menstrual period or a week before it
  • not be making use of antipyretic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rinaldo Roberto de Jesus Guirro

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Rinaldo Guirro, Professor

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 7, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations