Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy

NCT ID: NCT01872091

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Healthy Individuals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

cryotherapy by immersion

Intervention Type: OTHER

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;

Group Type: EXPERIMENTAL

Control group

Intervention Type: OTHER

Interventions

cryotherapy by immersion

Intervention Type: OTHER

Control group

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rinaldo Roberto de Jesus Guirro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rinaldo Guirro, Professor

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

Rinaldo Roberto de Jesus Guirro

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

U1111-1143-3579

Identifier Type: -

Identifier Source: org_study_id