Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy

Healthy Individuals Clinical Trial

Official title:

Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy by Immersion of the Forearm

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01872091
• Other study ID #: U1111-1143-3579
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 27, 2013
• Last updated: July 19, 2017
• Start date: May 2013
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Other:
• cryotherapy by immersion

• Control group

Locations

Country	Name	City	State
Brazil	Rinaldo Roberto de Jesus Guirro	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in skin temperature before and after cryotherapy by immersion of the forearm	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.	2 years
Primary	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	Blood flow velocity before and after immersion of the forearm cryotherapy	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.	2 years