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

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ClinicalTrials.gov Identifier: NCT03150563
Recruitment Status : Unknown
Verified May 2017 by Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte.
Recruitment status was:  Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte

Tracking Information
First Submitted Date  ICMJE May 6, 2017
First Posted Date  ICMJE May 12, 2017
Last Update Posted Date May 12, 2017
Actual Study Start Date  ICMJE May 9, 2017
Estimated Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
  • 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.
  • Pain after stretching session [ Time Frame: 1 minute after intervention ]
    Measurement from the visual analogue scale of 100 mm.
  • Functional performance [ Time Frame: 48 h after intervention ]
    Evaluation of functional performance with measures of vertical jump and shuttle run
  • Electromyographic responses of the hamstring [ Time Frame: 48 h after intervention ]
    Electromyographic responses of the hamstring muscles in performing knee extension and hip flexion
  • Passive torque [ Time Frame: 48 h after intervention ]
    Isokinetic performance evaluation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Differents Intensities of Passive Stretching on ROM, Neuromuscular and Performance in Soccer Players: A Blinded RCT
Official Title  ICMJE Effects of Different Intensities of Passive Static Stretching on Flexibility, Neuromuscular and Functional Performance in Soccer Athletes: A Blinded, Randomized Controlled Trial.
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:

The randomization process of the sample will be carried out through the electronic website http://www.randomization.com, carried out by a subject external to the experimental and evaluation procedures. With this data, the site will generate a specific coding for each group and will randomly distribute the subjects into four groups: Control Group (GC), Experiment Group 1 (GE1), Experiment Group (GE2) and Experiment Group 3 (GE3).

The distribution will be kept in an opaque and sealed envelope, being revealed only to P2 only at the time of intervention. The P1, who will carry out the measurements, will not know to which group the individual belongs. To maintain the "blinding" procedure of the study, each individual at the time of intervention will spend 10 minutes in the intervention room (being 4 minutes for preparation and 6 minutes for intervention) and each group will have a corresponding color for the convenience of P2 White, blue, green and yellow).

Primary Purpose: Treatment
Condition  ICMJE
  • Contracture of Muscle, Thigh
  • Muscle Rigidity
  • Strain of Hamstring Muscle (Disorder)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Passive static stretch
  • 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.
    Intervention: Other: Passive static stretch
  • 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.
    Intervention: Other: Passive static stretch
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 9, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2017
Estimated Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03150563
Other Study ID Numbers  ICMJE 1.883.129
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte
Study Sponsor  ICMJE Universidade Federal do Rio Grande do Norte
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wouber H de Brito Vieira, PhD Universidade Federal do Rio Grande do Norte
PRS Account Universidade Federal do Rio Grande do Norte
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP