- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02689544
Effects of Static Stretching and Dynamic in Flexibility and Performance: Blind and Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(1) male;
(2) were aged between 18 and 28 years old;
(3) Body mass index (BMI) of 21 to 25 kg / m2,
(4) not be participating in lower limb stretching programs;
(5) 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)
(6) no history of injury or disease in the lower limbs in the last six months, without previous surgery in this segment;
(7) lack of musculoskeletal, cardiorespiratory and neurological disorders that prevent the completion of the evaluation and treatment protocols;
(8) is not under the effect of medicines that cause muscle relaxation or that inhibit muscle tonic action
(9) 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).
Exclusion Criteria:
(1) start stretching practice in daily activities during the study period;
(2) not perform evaluative and intervention procedures;
(3) absence of at least one of the sessions of stretching protocol;
(4) appearance of lesions during the period in which the subject is inserted in the survey;
(5) 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: static stretching
Group of 15 volunteers (gSS)
|
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.
|
Experimental: dynamic stretching
Group of 15 volunteers (gDS)
|
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.
|
Other: control
Group of 15 volunteers (gC)
|
The control group volunteers no received intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion
Time Frame: Evaluation of range of motion after one month the application of stretching
|
Range of Motion measured by Universal Goniometer
|
Evaluation of range of motion after one month the application of stretching
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wouber H Vieira, Prof.Dr., Universidade Federal do Rio Grande do Norte
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.132.671
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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