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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02689544
Other study ID # 1.132.671
Secondary ID
Status Completed
Phase N/A
First received February 11, 2016
Last updated February 18, 2016
Start date June 2015
Est. completion date December 2015

Study information

Verified date February 2016
Source Universidade Federal do Rio Grande do Norte
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 28 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
intervention with static stretching
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 Stretching
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.
Control
The control group volunteers no received intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Germanna de Medeiros Barbosa

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion Range of Motion measured by Universal Goniometer Evaluation of range of motion after one month the application of stretching Yes
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