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

Primary Purpose

Contracture of Muscle, Thigh, Muscle Rigidity, Strain of Hamstring Muscle (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Passive static stretch
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contracture of Muscle, Thigh focused on measuring Stretching, Stretching sensation, Isokinetic dynamometry, Stretching load.

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Rio Grande do NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control Group

Experimental Group 1

Experimental Group 2

Experimental Group 3

Arm Description

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.

The experimental group 1 will have the sensation of "SENSATION SENSING WITHOUT DESCONFORT" as an intensity for the application of the passive stretch protocol.

The GE2 will have the feeling of "MAXIMUM DISORDER WITHOUT PAIN" as the as an intensity for the application of the passive stretch protocol.

GE3 will have the sensation of "MAXIMUM TOLERABLE PAIN" as the as an intensity for the application of the passive stretch protocol.

Outcomes

Primary Outcome Measures

Range of motion (ROM)
The measurement will be performed in two positions: with hip flexed at 90 ° and with extended leg elevation, using goniometry for measurement.

Secondary Outcome Measures

Pleasure after stretching program
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
Measurement from the visual analogue scale of 100 mm.
Functional performance
Evaluation of functional performance with measures of vertical jump and shuttle run
Electromyographic responses of the hamstring
Electromyographic responses of the hamstring muscles in performing knee extension and hip flexion
Passive torque
Isokinetic performance evaluation

Full Information

First Posted
May 6, 2017
Last Updated
May 9, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03150563
Brief Title
Differents Intensities of Passive Stretching on ROM, Neuromuscular and Performance in Soccer Players: A Blinded RCT
Official Title
Effects of Different Intensities of Passive Static Stretching on Flexibility, Neuromuscular and Functional Performance in Soccer Athletes: A Blinded, Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Anticipated)
Study Completion Date
November 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contracture of Muscle, Thigh, Muscle Rigidity, Strain of Hamstring Muscle (Disorder)
Keywords
Stretching, Stretching sensation, Isokinetic dynamometry, Stretching load.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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).
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
The experimental group 1 will have the sensation of "SENSATION SENSING WITHOUT DESCONFORT" as an intensity for the application of the passive stretch protocol.
Arm Title
Experimental Group 2
Arm Type
Experimental
Arm Description
The GE2 will have the feeling of "MAXIMUM DISORDER WITHOUT PAIN" as the as an intensity for the application of the passive stretch protocol.
Arm Title
Experimental Group 3
Arm Type
Experimental
Arm Description
GE3 will have the sensation of "MAXIMUM TOLERABLE PAIN" as the as an intensity for the application of the passive stretch protocol.
Intervention Type
Other
Intervention Name(s)
Passive static stretch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Range of motion (ROM)
Description
The measurement will be performed in two positions: with hip flexed at 90 ° and with extended leg elevation, using goniometry for measurement.
Time Frame
48 h after intervention
Secondary Outcome Measure Information:
Title
Pleasure after stretching program
Description
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.
Time Frame
1 minute after intervention
Title
Pain after stretching session
Description
Measurement from the visual analogue scale of 100 mm.
Time Frame
1 minute after intervention
Title
Functional performance
Description
Evaluation of functional performance with measures of vertical jump and shuttle run
Time Frame
48 h after intervention
Title
Electromyographic responses of the hamstring
Description
Electromyographic responses of the hamstring muscles in performing knee extension and hip flexion
Time Frame
48 h after intervention
Title
Passive torque
Description
Isokinetic performance evaluation
Time Frame
48 h after intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronan R Varela de Melo, Master
Phone
+5584991366307
Email
ronanriq@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Glauko A Figueiredo, Master
Phone
+5584991366307
Email
ronanriq@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wouber H de Brito Vieira, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59072-970
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronan R Varela de Melo, Master
Phone
+5584991366307
Email
ronanriq@gmail.com
First Name & Middle Initial & Last Name & Degree
Wouber H de Brito Vieira, PhD
First Name & Middle Initial & Last Name & Degree
Bento J Abreu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26347668
Citation
Apostolopoulos N, Metsios GS, Flouris AD, Koutedakis Y, Wyon MA. The relevance of stretch intensity and position-a systematic review. Front Psychol. 2015 Aug 18;6:1128. doi: 10.3389/fpsyg.2015.01128. eCollection 2015.
Results Reference
background
PubMed Identifier
24198679
Citation
Behm DG, Bradbury EE, Haynes AT, Hodder JN, Leonard AM, Paddock NR. Flexibility is not Related to Stretch-Induced Deficits in Force or Power. J Sports Sci Med. 2006 Mar 1;5(1):33-42. eCollection 2006.
Results Reference
background

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

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