NCT03094676

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

February 21, 2017

Last Update Submit

March 8, 2018

Conditions

Healthy Volunteers

Keywords

MassageAutonomic nervous systemRecovery of Physiological FunctionHeart Rate

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Heart rate.

    1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.

  • Oxygen saturation.

    1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.

  • Respiratory rate.

    1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.

Study Arms (5)

Control

NO INTERVENTION

Only the HRV will be followed for two hours without intervention.

Only Massage

EXPERIMENTAL

Only the massage, and will have the monitoring of the HRV on the techniques and accompanied for two hours.

Other: Massage

Only Exercise

EXPERIMENTAL

Only the exercise, and will have the monitoring of the HRV on the techniques and accompanied for two hours.

Other: Exercise

Exercise and Massage immediately

EXPERIMENTAL

Performing the exercise and massage immediately after, will be accompanied by the HRV during the techniques and two hours after.

Other: MassageOther: Exercise

Exercise and Massage after recovery

EXPERIMENTAL

Performing the exercise and massage will be applicated after recovery of HRV, will be accompanied by the HRV during the techniques and two hours afte

Other: MassageOther: Exercise

Interventions

MassageOTHER

Approximately 12 minutes of massage will be performed in full. The massage will be performed on the lower (anterior) and trunk (posterior)

Exercise and Massage after recoveryExercise and Massage immediatelyOnly Massage
ExerciseOTHER

A wingate protocol will be performed followed by 10 sets of 10 squats followed by jumps.

Exercise and Massage after recoveryExercise and Massage immediatelyOnly Exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Volunteers
  • Appropriate age limit
  • Male

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nilton Mantovani Junior

Presidente Prudente, São Paulo, 19025-833, Brazil

RECRUITING

Related Publications (1)

  • Mantovani Junior N, Pizzo Junior E, Dos Santos Siqueira M, de Souza Cavina AP, Pastre CM, Marques Vanderlei F. Effects of massage as a recuperative technique on autonomic modulation of heart rate and cardiorespiratory parameters: a study protocol for a randomized clinical trial. Trials. 2018 Aug 25;19(1):459. doi: 10.1186/s13063-018-2830-1.

    PMID: 30144819DERIVED

MeSH Terms

Interventions

MassageExercise

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator and the assessor will not receive information about the participant, not knowing, from which group the participant has just arrived for intervention in the investigator's case and the assessor will not receive group information in the HRV data packet.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 29, 2017

Study Start

April 9, 2018

Primary Completion

May 14, 2018

Study Completion

July 30, 2018

Last Updated

March 12, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)