Effects of Massage in Different Moments of Application on Autonomic Cardiac Modulation and Cardiorespiratory Parameters

Healthy Volunteers Clinical Trial

Official title:

Effects of Massage as a Recuperative Technique in Different Moments of Application on Autonomic Cardiac Modulation and Cardiorespiratory Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03094676
• Other study ID #: 57584116.6.0000.5402
• Status: Recruiting
• Phase: N/A
• First received: February 21, 2017
• Last updated: March 8, 2018
• Start date: April 9, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: March 2018
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Performing physical exercise alters the body's homeostasis, and recuperative techniques seek to anticipate and potentiate the body's recovery. One of the ways to demonstrate a recovery of the organism is the resumption of autonomic cardiac modulation analyzed through heart rate variability (HRV), a method of global assessment of the behavior of the autonomic nervous system. Among the recovery techniques, massage is the most widely used technique in sports. Therefore, the objective of the study will be to measure the effects of massage as a recuperative technique on autonomic cardiac modulation at different moments of application. It will be a randomized clinical trial where there will be five stages of evaluation. In the first stage, the behavior of the baseline HRV will be evaluated, in the second stage the behavior of the HRV in front of the massage, in the third stage the behavior of the HRV in front of the stress protocol, in the fourth stage the HRV behavior after the stress protocol and immediately after Execution of the massage and finally in the 5th stage where the HRV behavior will be evaluated after the stress protocol and the massage application will be performed at the moment of HRV recovery. The stress protocol will be composed of squats followed by jumps and wingate test, and massage by slides in the anterior thighs and posterior trunk. The HRC indexes in the time domain, frequency domain and Poincaré plot, as well as cardiorespiratory parameters and a questionnaire on individual touch perception will be analyzed. The descriptive statistical method will be used and comparisons of cardiorespiratory parameters and HRV indices will be performed using the analysis of variance technique for repeated measures model in the two factor scheme. The level of significance will be p <0.05 for all tests.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy Volunteers

• Appropriate age limit

• Male

Exclusion Criteria:

• Smokers

• Use of drugs that influence the autonomic modulation of the heart.

• Ethicalists

• Carriers of known metabolic and / or endocrine disorders

• Sedentary individuals, insufficiently active and very active according to IPAQ

• Individuals outside the BMI range

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Massage
Approximately 12 minutes of massage will be performed in full. The massage will be performed on the lower (anterior) and trunk (posterior)
• Exercise
A wingate protocol will be performed followed by 10 sets of 10 squats followed by jumps.

Locations

Country	Name	City	State
Brazil	Nilton Mantovani Junior	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability (HRV) - Linear indices - Frequency domain	HRV is a noninvasive and selective way of assessing the autonomic function being determined by analyzing the time series of the RR intervals. The HRV analysis will be performed by the Polar Electro Oy - V800 cardiofrequency meter.; In the analysis of the linear methods, 3 rMSSD, SDNN and pNN50 indices will be used within the time domain. RMSSD corresponds to the square root of the square mean of the differences between the adjacent normal RR intervals in a time interval expressed in milliseconds. The SDNN index represents the standard deviation of all normal RR intervals recorded over a time interval, expressed in milliseconds. And finally, the pNN50 index is the percentage of adjacent RR intervals with a duration difference greater than 50 milliseconds.	First 5 minutes of rest; During recovery 5 minutes initial; 10º to 15ºm; 20º to 25ºm; 30º to 35ºm; 40º to 45ºm; 50º to 55ºm; 60º to 65ºm; 70º to 75ºm; 90º to 95ºm; 115º to 120ºm.
Primary	Heart Rate Variability (HRV) - Linear indices - Time domain	HRV is a noninvasive and selective way of assessing the autonomic function being determined by analyzing the time series of the RR intervals. The HRV analysis will be performed by the Polar Electro Oy - V800 cardiofrequency meter.; In the analysis of the linear methods, 3 LF, HF and LF / HF indices will be used within the frequency domain. Low frequency corresponds to frequencies between 0.04 and 0.15 Hz (LF - frequency between 0.04 and 0.15 Hz), high frequency (HF - frequency between 0.15 and 0.4 Hz) and the ratio between these components ( LF / HF). These indices shall be expressed in ms² and standard units.	First 5 minutes of rest; During recovery 5 minutes initial; 10º to 15ºm; 20º to 25ºm; 30º to 35ºm; 40º to 45ºm; 50º to 55ºm; 60º to 65ºm; 70º to 75ºm; 90º to 95ºm; 115º to 120ºm.
Primary	Heart Rate Variability (HRV) - Plot of Poincaré	HRV is a noninvasive and selective way of assessing the autonomic function being determined by analyzing the time series of the RR intervals. The HRV analysis will be performed by the Polar Electro Oy - V800 cardiofrequency meter.; The Poincaré plot is a map of points in Cartesian coordinates constructed from the values of the RR intervals obtained, where each point is represented on the x (horizontal / abscissa) axis by the preceding normal RR interval e, on the y axis (vertical / ordinate) By the following RR interval	First 5 minutes of rest; During recovery 5 minutes initial; 10º to 15ºm; 20º to 25ºm; 30º to 35ºm; 40º to 45ºm; 50º to 55ºm; 60º to 65ºm; 70º to 75ºm; 90º to 95ºm; 115º to 120ºm.
Secondary	Heart rate.	Heart rate is the number of heartbeats per unit of time. The heart rate will be measured by a heart monitor, and will be displayed in beats per minute (BPM).	1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
Secondary	Oxygen saturation.	Oxygen saturation is the percentage of arterial blood hemoglobin that is bound to oxygen. Pulse oximetry will be used to gauge the oxygen saturation, pulse oximetry is the way to measure how much oxygen your blood is carrying. ... The oxygen level measured with a finger oximeter, and the result of this measurement is called the saturation level of oxygen (SatO2)	1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
Secondary	Respiratory rate.	Respiratory rate is the designation given to the number of respiratory cycles that is completed in a specific time span, being more commonly expressed in breaths per minute. The respiratory rate will default to 1 minute to express the respiratory cycle number. The respiratory rate will be counted by an evaluator.	1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.