Contracture of Muscle, ThighNCT03150563
Differents Intensities of Passive Stretching on ROM, Neuromuscular and Performance in Soccer Players: A Blinded RCT
A study testing Passive static stretch in people with Contracture of Muscle, Thigh and Muscle Rigidity, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Contracture of Muscle, Thigh, Muscle Rigidity, Strain of Hamstring Muscle (Disorder)
- What is being tested?
- Passive static stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 9 May 2017to 30 Nov 2017
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (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 °.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59072-970
Ronan R Varela de Melo, Master, +5584991366307, ronanriq@gmail.com
Wouber H de Brito Vieira, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Passive static stretch
- Keywords
- Stretching, Stretching sensation, Isokinetic dynamometry, Stretching load.
- Medical subject headings
- Contracture, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive static stretchOther
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 group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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 Group 1 | Experimental | The experimental group 1 will have the sensation of "SENSATION SENSING WITHOUT DESCONFORT" as an intensity for the application of the passive stretch protocol. Receives: Other: Passive static stretch |
| Experimental Group 2 | Experimental | The GE2 will have the feeling of "MAXIMUM DISORDER WITHOUT PAIN" as the as an intensity for the application of the passive stretch protocol. Receives: Other: Passive static stretch |
| Experimental Group 3 | Experimental | GE3 will have the sensation of "MAXIMUM TOLERABLE PAIN" as the as an intensity for the application of the passive stretch protocol. Receives: Other: Passive static stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 h after intervention
Secondary outcomes (5)
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.
Measured: 1 minute after intervention
Pain after stretching session
Measurement from the visual analogue scale of 100 mm.
Measured: 1 minute after intervention
Functional performance
Evaluation of functional performance with measures of vertical jump and shuttle run
Measured: 48 h after intervention
Electromyographic responses of the hamstring
Electromyographic responses of the hamstring muscles in performing knee extension and hip flexion
Measured: 48 h after intervention
Passive torque
Isokinetic performance evaluation
Measured: 48 h after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start9 May 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contracture of Muscle, ThighStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wouber Hérickson de Brito Vieira, Universidade Federal do Rio Grande do Norte
- Investigators
- Wouber H de Brito Vieira, PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150563
- Sponsor's protocol ID
- 1.883.129
- Status last verified
- May 2017
- First submitted
- 6 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26347668Behm 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.
PubMed 24198679
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Intensities of Passive Static Stretching on Flexibility, Neuromuscular and Functional Performance in Soccer Athletes: A Blinded, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03150563
- Acronym / sponsor ID
- 1.883.129
- Keywords
- Stretching, Stretching sensation, Isokinetic dynamometry, Stretching load.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 12 May 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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 Group 1 | Experimental | Other: Passive static stretchThe experimental group 1 will have the sensation of "SENSATION SENSING WITHOUT DESCONFORT" as an intensity for the application of the passive stretch protocol. |
| Experimental Group 2 | Experimental | Other: Passive static stretchThe GE2 will have the feeling of "MAXIMUM DISORDER WITHOUT PAIN" as the as an intensity for the application of the passive stretch protocol. |
| Experimental Group 3 | Experimental | Other: Passive static stretchGE3 will have the sensation of "MAXIMUM TOLERABLE PAIN" as the as an intensity for the application of the passive stretch protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (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 °.
Key exclusion criteria (1 listed)
- (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.
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 |
|---|---|---|
| Passive static stretchEach 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. | Other | Experimental Group 1, Experimental Group 2, Experimental Group 3 |
Primary outcome
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.
5 secondary outcomes
Pleasure after stretching program
Time frame: 1 minute after intervention
Pain after stretching session
Time frame: 1 minute after intervention
Functional performance
Time frame: 48 h after intervention
Electromyographic responses of the hamstring
Time frame: 48 h after intervention
Passive torque
Time frame: 48 h after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Background: PubMed 26347668Apostolopoulos 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.
- Background: PubMed 24198679Behm 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.
- Individual participant dataSharing planned: No
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.
Wouber H de Brito Vieira, PhD principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive static stretch in people with Contracture of Muscle, Thigh and Muscle Rigidity, run by Universidade Federal do Rio Grande do Norte 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 1 inclusion and 1 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 May 2017. 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?
Contact Ronan R Varela de Melo, Master (+5584991366307, ronanriq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (ROM) (time frame: 48 h after intervention). 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 NCT03150563, which also lists 2 linked publications.
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 May 2017.