Neuromuscular ManifestationsNCT02689544
Effects of Static Stretching and Dynamic in Flexibility and Performance: Blind and Randomized Clinical Trial
A study testing intervention with static stretching and intervention with Dynamic Stretching in people with Neuromuscular Manifestations, run by Germanna de Medeiros Barbosa.
Trial summary
The purpose of this study is analyze the effects, acute and chronic, static and dynamic stretching on flexibility and neuromuscular and functional performance in active, healthy individuals. Study hypothesis: 1. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Manifestations
- What is being tested?
- intervention with static stretching and intervention with Dynamic Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2015
- 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 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (1) male;
- were aged between 18 and 28 years old;
- Body mass index (BMI) of 21 to 25 kg / m2,
- not be participating in lower limb stretching programs;
- be healthy, according to Physical Activity Readiness Questionnaire (PAR-Q) and perform physical activity (recreational, not competitive level) for at least 3 times a week, according to the International Physical Activity Questionnaire (IPAQ)
- no history of injury or disease in the lower limbs in the last six months, without previous surgery in this segment;
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- lack of musculoskeletal, cardiorespiratory and neurological disorders that prevent the completion of the evaluation and treatment protocols;
- is not under the effect of medicines that cause muscle relaxation or that inhibit muscle tonic action
- has ROM limitation (degree of muscle shortening) of at least 15 ° of active extension of joelho21, the non-dominant leg (considering 180 the full extent with hip positioned at 90 ° of flexion).
Who cannot join
- (1) start stretching practice in daily activities during the study period;
- not perform evaluative and intervention procedures;
- absence of at least one of the sessions of stretching protocol;
- appearance of lesions during the period in which the subject is inserted in the survey;
- withdrawal in the study. Thus, it excluded eight volunteers, three per occurrence of injuries during the study period and five per withdrawal, concluding the study with a total of 45 subjects.
About this study
Official title: Acute and Chronic Effects of Static and Dynamic Stretching on Flexibility and Neuromuscular and Functional Performance in Healthy Subjects: a Blinded and Randomized Clinical Trial
The purpose of this study is analyze the effects, acute and chronic, static and dynamic stretching on flexibility and neuromuscular and functional performance in active, healthy individuals.
Study hypothesis:
- Static stretching program improves flexibility and reduces neuromuscular and functional performance in active, healthy individuals.
- Static stretching program improves flexibility and neuromuscular and functional performance in active, healthy individuals.
Read the detailed description
It is a randomized, blinded clinical trial where the first researcher (P1) was responsible for assessments and reassessments; the second searcher (P2) at randomization and inquiry of the subjects in the intervention protocol and the third investigator (P3) for the statistical analyzes.The research was conducted at the Laboratory of therapeutic practices of the Department of Physical Therapy, Federal University of Rio Grande do Norte (UFRN) and started after the approval of the ethics committee.The sample was recruited by convenience by written disclosure, electronics and personal contact in academies and higher education institutions in the city of Natal / RN. The volunteers were randomly distributed through the electronic site http://www.randomization.com (Code: 21318). Two pieces of information were inserted, namely: the sample size and the number of groups. With this data, the site has generated a specific encoding for each group and distributed the subjects randomly into three groups: static stretching (gAE); dynamic stretching (gAD) and control (gC).
Sample size calculation
For the sample size calculation was used G * Power 3.1.0 software and the procedures followed the recommendations of studies prévios45. Based on a pilot study of four volunteers, it has adopted a power of 0.95, considering a significance level of 5%, a correlation coefficient of 0.5, and 0.25 effect size for both, It calculated a "n" sample of 15 individuals for each group ("n" sample = 45). This analysis was performed to reduce the chance of Type II error and to determine the minimum number of individuals required for this investigation. Thus, the sample size was sufficient to provide 95.5% statistical power.
Procedures and evaluation measures
At first all subjects were recorded in the survey through an evaluation form containing information on identification, weight, height, injury history and physical activity .
After the process of randomization and allocation held by P2, the volunteers underwent the first evaluation (AV1) under the instruction of P1. This evaluation was performed at least 48 hours before the 1st stretching session to prevent possible residual effects of isokinetic and functional testing. Other evaluations AV2, AV3 and AV4, were made immediately after the 1st (acute response) and 10th sessions (acute post elongation) and 48 hours after the last (residual chronic response), respectively, for EAG and GAD. Already the subject of gc were subject only to the four evaluation processes, where the last assessment (AV4) coincided with the time related to the stretching protocol of the experimental groups. Despite receiving the same guidelines of the other groups on the importance of stretching activities routines during the study period the volunteers were told they should not perform stretching in the day-to-day.
All had non-dominant leg (MND) tested for flexibility, neuromuscular performance (muscle latency time and isokinetic performance) and functional performance (functional tests) in all four assessments. The MND was used because it is considered less skilled and more trainable, when compared to the MD46. For their identification was asked which member preferred to kick a bola15. However, during the interventions in the experimental groups (GAE, GAD), both members were elongated, evaluating the pain sensation at the end of each session and at the end of the intervention protocols, sensory perception (pleasure / displeasure) in performing elongation. The day of the period in which prevailed the assessments and reassessments was on afternoon shift.
- Conditions
- Neuromuscular Manifestations
- Being tested
- intervention with static stretching, intervention with Dynamic Stretching, Control
- Keywords
- exercise muscle stretching, range of motion, dynamometer of muscle strength, electromyography
- Medical subject headings
- Neuromuscular Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention with static stretchingOther
Members of static stretching group performed three sets of 30 second self hamstring stretch (IT) of both lower limbs, with 30 seconds of rest between sets, totaling 3 minute intervention so.
intervention with Dynamic StretchingOther
Each subject contracting antagonist muscle (quadriceps) to the target muscle (hamstring), performing dynamic movements of hip flexion with the knee extended, repeated every 1 second. They amounted to 3 of 30 repetitions completing approximately three minutes of dynamic stretching for each lower.
ControlOther
The control group volunteers no received intervention
| Study group | Role | What they receive |
|---|---|---|
| static stretching | Experimental | Group of 15 volunteers (gSS) Receives: Other: intervention with static stretching |
| dynamic stretching | Experimental | Group of 15 volunteers (gDS) Receives: Other: intervention with Dynamic Stretching |
| control | Other | Group of 15 volunteers (gC) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Range of Motion measured by Universal Goniometer
Measured: Evaluation of range of motion after one month the application of stretching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular ManifestationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germanna de Medeiros Barbosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Germanna de Medeiros Barbosa, Universidade Federal do Rio Grande do Norte
- Investigators
- Wouber H Vieira, Prof.Dr., Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689544
- Sponsor's protocol ID
- 1.132.671
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Static and Dynamic Stretching on Flexibility and Neuromuscular and Functional Performance in Healthy Subjects: a Blinded and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02689544
- Acronym / sponsor ID
- 1.132.671
- Conditions
- Neuromuscular Manifestations
- Keywords
- exercise muscle stretching, range of motion, dynamometer of muscle strength, electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Germanna de Medeiros BarbosaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
The purpose of this study is analyze the effects, acute and chronic, static and dynamic stretching on flexibility and neuromuscular and functional performance in active, healthy individuals.
Study hypothesis:
- Static stretching program improves flexibility and reduces neuromuscular and functional performance in active, healthy individuals.
- Static stretching program improves flexibility and neuromuscular and functional performance in active, healthy individuals.
Detailed description
It is a randomized, blinded clinical trial where the first researcher (P1) was responsible for assessments and reassessments; the second searcher (P2) at randomization and inquiry of the subjects in the intervention protocol and the third investigator (P3) for the statistical analyzes.The research was conducted at the Laboratory of therapeutic practices of the Department of Physical Therapy, Federal University of Rio Grande do Norte (UFRN) and started after the approval of the ethics committee.The sample was recruited by convenience by written disclosure, electronics and personal contact in academies and higher education institutions in the city of Natal / RN. The volunteers were randomly distributed through the electronic site http://www.randomization.com (Code: 21318). Two pieces of information were inserted, namely: the sample size and the number of groups. With this data, the site has generated a specific encoding for each group and distributed the subjects randomly into three groups: static stretching (gAE); dynamic stretching (gAD) and control (gC).
Sample size calculation
For the sample size calculation was used G * Power 3.1.0 software and the procedures followed the recommendations of studies prévios45. Based on a pilot study of four volunteers, it has adopted a power of 0.95, considering a significance level of 5%, a correlation coefficient of 0.5, and 0.25 effect size for both, It calculated a "n" sample of 15 individuals for each group ("n" sample = 45). This analysis was performed to reduce the chance of Type II error and to determine the minimum number of individuals required for this investigation. Thus, the sample size was sufficient to provide 95.5% statistical power.
Procedures and evaluation measures
At first all subjects were recorded in the survey through an evaluation form containing information on identification, weight, height, injury history and physical activity .
After the process of randomization and allocation held by P2, the volunteers underwent the first evaluation (AV1) under the instruction of P1. This evaluation was performed at least 48 hours before the 1st stretching session to prevent possible residual effects of isokinetic and functional testing. Other evaluations AV2, AV3 and AV4, were made immediately after the 1st (acute response) and 10th sessions (acute post elongation) and 48 hours after the last (residual chronic response), respectively, for EAG and GAD. Already the subject of gc were subject only to the four evaluation processes, where the last assessment (AV4) coincided with the time related to the stretching protocol of the experimental groups. Despite receiving the same guidelines of the other groups on the importance of stretching activities routines during the study period the volunteers were told they should not perform stretching in the day-to-day.
All had non-dominant leg (MND) tested for flexibility, neuromuscular performance (muscle latency time and isokinetic performance) and functional performance (functional tests) in all four assessments. The MND was used because it is considered less skilled and more trainable, when compared to the MD46. For their identification was asked which member preferred to kick a bola15. However, during the interventions in the experimental groups (GAE, GAD), both members were elongated, evaluating the pain sensation at the end of each session and at the end of the intervention protocols, sensory perception (pleasure / displeasure) in performing elongation. The day of the period in which prevailed the assessments and reassessments was on afternoon shift.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| static stretching | Experimental | Other: intervention with static stretchingGroup of 15 volunteers (gSS) |
| dynamic stretching | Experimental | Other: intervention with Dynamic StretchingGroup of 15 volunteers (gDS) |
| control | Other | Other: ControlGroup of 15 volunteers (gC) |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- (1) male;
Key exclusion criteria (5 listed)
- (1) start stretching practice in daily activities during the study period;
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 |
|---|---|---|
| intervention with static stretchingMembers of static stretching group performed three sets of 30 second self hamstring stretch (IT) of both lower limbs, with 30 seconds of rest between sets, totaling 3 minute intervention so. | Other | static stretching |
| intervention with Dynamic StretchingEach subject contracting antagonist muscle (quadriceps) to the target muscle (hamstring), performing dynamic movements of hip flexion with the knee extended, repeated every 1 second. They amounted to 3 of 30 repetitions completing approximately three minutes of dynamic stretching for each lower. | Other | dynamic stretching |
| ControlThe control group volunteers no received intervention | Other | control |
Primary outcome
Range of Motion
Time frame: Evaluation of range of motion after one month the application of stretching
Range of Motion measured by Universal Goniometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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 Vieira, Prof.Dr. principal investigator
Universidade Federal do Rio Grande do Norte
Questions about this trial
What is this clinical trial studying?
A study testing intervention with static stretching and intervention with Dynamic Stretching in people with Neuromuscular Manifestations, run by Germanna de Medeiros Barbosa.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: Evaluation of range of motion after one month the application of stretching). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2016.