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Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy

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ClinicalTrials.gov Identifier: NCT01872091
Recruitment Status : Unknown
Verified July 2017 by Rinaldo Roberto de Jesus Guirro, University of Sao Paulo.
Recruitment status was:  Enrolling by invitation
First Posted : June 7, 2013
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Rinaldo Roberto de Jesus Guirro, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Healthy Individuals Other: cryotherapy by immersion Other: Control group Not Applicable

Detailed Description:
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. Thus, this study aims to evaluate neuromuscular and biomechanical assess hemodynamic and autonomic cardiovascular, and investigate the occurrence of changes in conduction velocity due to the superficial blood cryotherapy by immersion of the forearm. The study will be conducted in 40 volunteers, female, between 18 and 30 years, university, healthy. They will be divided into two groups of 20 volunteers, the group immersion cryotherapy (GI) and control group (CG). For immersion cryotherapy group (GI), individuals will be the right arm to the elbow immersed in a container of water at 6°C ± 2°C for 15 minutes. In the control group (CG), volunteers will remain at rest with the right arm in the same position within a vessel containing water at a temperature indifferent for the same period of 15 minutes. The temperature analysis is performed using a infrared thermographer, muscular strength and synergism will be evaluated by a load cell connected to the electromyograph to examine muscle activation of wrist flexors and extensors, serratus anterior, upper and middle trapezius. The records beat to beat blood pressure and heart rate for cardiovascular autonomic and hemodynamic evaluation will be carried out by means of equipment and Finometer electrocardiogram, respectively, before and after application of cryotherapy. In turn, the data of blood flow velocity will be collected by means of Doppler Ultrasound. The results will be processed and analyzed using descriptive statistics, submitted to a linear regression model with mixed effects (fixed and random effects), with p≤0.05.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy by Immersion of the Forearm
Actual Study Start Date : May 2013
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: cryotherapy by immersion
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
Experimental: Control group
(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



Primary Outcome Measures :
  1. Evaluate the strength and muscle synergism after cryotherapy immersion [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Blood flow velocity before and after immersion of the forearm cryotherapy [ Time Frame: 2 years ]
    The data of blood flow velocity will be collected through the portable Doppler ultrasound wave continues. Immediately before the strength tests will be collected the data from the radial artery blood flow (3 times per collection), so there are no changes due to muscular work required in the handgrip test.


Other Outcome Measures:
  1. Changes in skin temperature before and after cryotherapy by immersion of the forearm [ Time Frame: 2 years ]
    The skin temperature data will be acquired by a digital infrared thermographer. Immediately before the strength tests will be collected temperature data cutaneous (3 times per collection), so there are no changes due to muscular work required in testing grip.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872091


Locations
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Brazil
Rinaldo Roberto de Jesus Guirro
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Study Director: Rinaldo Guirro, Professor University of Sao Paulo

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Responsible Party: Rinaldo Roberto de Jesus Guirro, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01872091     History of Changes
Other Study ID Numbers: U1111-1143-3579
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017