Healthy VolunteersNCT03094676
Effects of Massage in Different Moments of Application on Autonomic Cardiac Modulation and Cardiorespiratory Parameters
A study testing Massage and Exercise in people with Healthy Volunteers, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Massage and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Apr 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers
- Appropriate age limit
- Male
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Nilton Mantovani Junior
Presidente Prudente, São Paulo, 19025-833
Nilton M Junior, Mr., +55(18)996543-3637, nmantovanijunior@gmail.com
About this study
Official title: Effects of Massage as a Recuperative Technique in Different Moments of Application on Autonomic Cardiac Modulation and Cardiorespiratory Parameters
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.
- Conditions
- Healthy Volunteers
- Being tested
- Massage, Exercise
- Keywords
- Massage, Autonomic nervous system, Recovery of Physiological Function, Heart Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
Approximately 12 minutes of massage will be performed in full. The massage will be performed on the lower (anterior) and trunk (posterior)
ExerciseOther
A wingate protocol will be performed followed by 10 sets of 10 squats followed by jumps.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Massage |
| Only Exercise | Experimental | Only the exercise, and will have the monitoring of the HRV on the techniques and accompanied for two hours. Receives: 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. Receives: Other: Massage; Other: 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 Receives: Other: Massage; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
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).
Measured: 1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
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)
Measured: 1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
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.
Measured: 1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start9 Apr 2018 (estimated)
- Primary completion14 May 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilton Mantovani Junior, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094676
- Sponsor's protocol ID
- 57584116.6.0000.5402
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2017
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30144819
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage as a Recuperative Technique in Different Moments of Application on Autonomic Cardiac Modulation and Cardiorespiratory Parameters
- ClinicalTrials.gov ID
- NCT03094676
- Acronym / sponsor ID
- 57584116.6.0000.5402
- Conditions
- Healthy Volunteers
- Keywords
- Massage, Autonomic nervous system, Recovery of Physiological Function, Heart Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 9 Apr 2018 (estimated)
- Primary completion
- 14 May 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Only the HRV will be followed for two hours without intervention. |
| Only Massage | Experimental | Other: MassageOnly the massage, and will have the monitoring of the HRV on the techniques and accompanied for two hours. |
| Only Exercise | Experimental | Other: ExerciseOnly the exercise, and will have the monitoring of the HRV on the techniques and accompanied for two hours. |
| Exercise and Massage immediately | Experimental | Other: Massage, Other: ExercisePerforming the exercise and massage immediately after, will be accompanied by the HRV during the techniques and two hours after. |
| Exercise and Massage after recovery | Experimental | Other: Massage, Other: ExercisePerforming the exercise and massage will be applicated after recovery of HRV, will be accompanied by the HRV during the techniques and two hours afte |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Volunteers
- Appropriate age limit
- Male
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageApproximately 12 minutes of massage will be performed in full. The massage will be performed on the lower (anterior) and trunk (posterior) | Other | Exercise and Massage after recovery, Exercise and Massage immediately, Only Massage |
| ExerciseA wingate protocol will be performed followed by 10 sets of 10 squats followed by jumps. | Other | Exercise and Massage after recovery, Exercise and Massage immediately, Only Exercise |
Primary outcome
Heart Rate Variability (HRV) - Linear indices - Frequency domain
Time frame: 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.
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.
Heart Rate Variability (HRV) - Linear indices - Time domain
Time frame: 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.
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.
Heart Rate Variability (HRV) - Plot of Poincaré
Time frame: 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.
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
3 secondary outcomes
Heart rate.
Time frame: 1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
Oxygen saturation.
Time frame: 1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
Respiratory rate.
Time frame: 1, 3, 5, 7, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 and 120 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Derived from this study: PubMed 30144819Mantovani 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Exercise in people with Healthy Volunteers, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) - Linear indices - Frequency domain (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.