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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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;
Show all 9Show fewer
  • 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:

  1. Static stretching program improves flexibility and reduces neuromuscular and functional performance in active, healthy individuals.
  2. 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.

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 groups in NCT02689544
Study groupRoleWhat they receive
static stretchingExperimentalGroup of 15 volunteers (gSS)
Receives: Other: intervention with static stretching
dynamic stretchingExperimentalGroup of 15 volunteers (gDS)
Receives: Other: intervention with Dynamic Stretching
controlOtherGroup of 15 volunteers (gC)
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted24 Feb 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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)
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

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.

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