Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT01872091
Collaborator
(none)
40
1
2
55
0.7

Study Details

Study Description

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
  • Other: cryotherapy by immersion
  • Other: Control group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 1, 2013
Actual Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate the strength and muscle synergism after cryotherapy immersion [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rinaldo Roberto de Jesus Guirro Ribeirão Preto São Paulo Brazil 14049-900

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

  • Study Director: Rinaldo Guirro, Professor, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rinaldo Roberto de Jesus Guirro, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01872091
Other Study ID Numbers:
  • U1111-1143-3579
First Posted:
Jun 7, 2013
Last Update Posted:
Jul 21, 2017
Last Verified:
Jul 1, 2017

Study Results

No Results Posted as of Jul 21, 2017