Differents Intensities of Passive Stretching on ROM, Neuromuscular and Performance in Soccer Players: A Blinded RCT

May 9, 2017 updated by: Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte

Effects of Different Intensities of Passive Static Stretching on Flexibility, Neuromuscular and Functional Performance in Soccer Athletes: A Blinded, Randomized Controlled Trial.

Intensity is a "qualitative" variable of a muscle stretching protocol, which is very little studied due to its inherent characteristic of the individual being stretched. However, it was pointed out as an important factor for ADM gain. To verify the effects of different intensities of static passive stretching on flexibility, neuromuscular and functional performance in soccer athletes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is a randomized, controlled, clinical trial, composed of male subjects, soccer players, randomly divided into 4 groups: Control Group (CG), Experimental Group 1 (GE1), Experimental Group 2 (GE2) And Experimental Group 3 (GE3). Initially, the measurements of flexibility (passive and active), neuromuscular (muscular passive torque, electromyographic activity), and functional (vertical jump and shuttle run test) of non-dominant lower limbs, performed before and immediately after the 1st And 48 hours after the last session. The GC will only be submitted for initial evaluation and final re-evaluation. The experimental groups will undergo a protocol of static passive stretching containing 10 sessions, divided into 3 weekly sessions, with 3 maneuvers of 30 s, but with different intensities (Tolerable Maximum Pain, Maximum No Pain Discomfort, and Stretching Sensation Without Discomfort) Established from a PERFLEX-modified visual scale. Groups with higher static passive stretching intensities (Maximum Tolerable Pain and Maximum Painless Discomfort) are expected to have greater gains in flexibility, with no change in muscle passive torque, electromyographic activity and functional performance, while the intensity of Feeling of Stretching without Discomfort (in a comfort zone) provides a greater decrease of the muscular passive torque, without significant change of the flexibility, in individual athletes of soccer. This work may contribute to the clinical practice of health professionals, since it seeks to improve the elaboration of the clinical prescription of protocols of static passive stretching (whether performed by the individual or not), establishing optimal levels of intensity for a given muscle group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ronan R Varela de Melo, Master
  • Phone Number: +5584991366307
  • Email: ronanriq@gmail.com

Study Contact Backup

  • Name: Glauko A Figueiredo, Master
  • Phone Number: +5584991366307
  • Email: ronanriq@gmail.com

Study Locations

  • Brazil
    • RN
      • Natal, RN, Brazil, 59072-970
        • Recruiting
        • Federal University of Rio Grande do Norte
        • Contact:
        • Principal Investigator:
          • Wouber H de Brito Vieira, PhD
        • Sub-Investigator:
          • Bento J Abreu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • (1) being male; (2) age range between 18 and 35 years of age; (3) Body Mass Index (BMI) between 19 and 27; (4) be a soccer player with 4 to 5x weekly training; (5) not participating in lower limb stretching programs; (6) no history of injury, trauma, previous surgeries and lower limb disease in the last 6 months; (7) absence of musculoskeletal, cardiorespiratory and neurological disorders that prevent the accomplishment of evaluation and treatment protocols; (8) not under the action of drugs that cause muscle relaxation or that may inhibit tonic muscle action (9) present a limitation of WMD (muscular shortening degree) with ischiatibial extensibility of less than 165 degrees of active extension of the knee with the hip Flexed at 90 °.

Exclusion Criteria:

  • (1) initiate stretching practice involving LLLs in daily activities outside the collection site during the study period; (2) not performing any of the evaluation and / or intervention procedures; (3) discontinuance in participating in the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
The subjects of the CG will receive the same orientations of the other groups in relation to the importance of the routines of stretching activities, but during the study period, they will not be able to perform stretches during their day to day life.
Experimental: Experimental Group 1
The experimental group 1 will have the sensation of "SENSATION SENSING WITHOUT DESCONFORT" as an intensity for the application of the passive stretch protocol.
Other: Passive static stretch
Each experimental group will be submitted to 10 (ten) sessions, with three (3) weekly sessions of static passive stretching, with a 48 h interval between them. Each session will be performed 3 (three) maneuvers containing a duration of 30 seconds, this being the same rest time, performed in all experimental groups.
Experimental: Experimental Group 2
The GE2 will have the feeling of "MAXIMUM DISORDER WITHOUT PAIN" as the as an intensity for the application of the passive stretch protocol.
Other: Passive static stretch
Each experimental group will be submitted to 10 (ten) sessions, with three (3) weekly sessions of static passive stretching, with a 48 h interval between them. Each session will be performed 3 (three) maneuvers containing a duration of 30 seconds, this being the same rest time, performed in all experimental groups.
Experimental: Experimental Group 3
GE3 will have the sensation of "MAXIMUM TOLERABLE PAIN" as the as an intensity for the application of the passive stretch protocol.
Other: Passive static stretch
Each experimental group will be submitted to 10 (ten) sessions, with three (3) weekly sessions of static passive stretching, with a 48 h interval between them. Each session will be performed 3 (three) maneuvers containing a duration of 30 seconds, this being the same rest time, performed in all experimental groups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Range of motion (ROM)
Time Frame: 48 h after intervention
The measurement will be performed in two positions: with hip flexed at 90 ° and with extended leg elevation, using goniometry for measurement.
48 h after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pleasure after stretching program
Time Frame: 1 minute after intervention
Each volunteer will be asked shortly after each session what was the pleasure felt in achieving the sensation of stretching, which is indicated by the feeling scale.
1 minute after intervention
Pain after stretching session
Time Frame: 1 minute after intervention
Measurement from the visual analogue scale of 100 mm.
1 minute after intervention
Functional performance
Time Frame: 48 h after intervention
Evaluation of functional performance with measures of vertical jump and shuttle run
48 h after intervention
Electromyographic responses of the hamstring
Time Frame: 48 h after intervention
Electromyographic responses of the hamstring muscles in performing knee extension and hip flexion
48 h after intervention
Passive torque
Time Frame: 48 h after intervention
Isokinetic performance evaluation
48 h after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Rio Grande do Norte

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wouber H de Brito Vieira, PhD, Universidade Federal do Rio Grande do Norte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1.883.129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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