Clinical trial NCT01872091: Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy
Official title: Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy by Immersion of the Forearm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Individuals
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Evaluate the strength and muscle synergism after cryotherapy immersion
timeFrame: 2 years
Secondary outcomes:
measure: Blood flow velocity before and after immersion of the forearm cryotherapy
timeFrame: 2 years
Other outcomes:
measure: Changes in skin temperature before and after cryotherapy by immersion of the forearm
timeFrame: 2 years
Locations:
city: Ribeirão Preto
country: Brazil
facility: Rinaldo Roberto de Jesus Guirro
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rinaldo Guirro, Professor
role: STUDY_DIRECTOR
References: