FlexibilityNCT02478606
Passive Static Stretching and Proprioceptive Neuromuscular Facilitation in Musculoskeletal Aspects
A study testing Muscle Stretching Exercises in people with Flexibility and Range of Motion, run by Federal University of Rio Grande do Sul.
Trial summary
This study investigates the influence of two different stretching techniques on the flexibility of the muscles that are in the posterior thigh, after a training period. The study will last for six weeks where the volunteers need to go to the lab twice for evaluation, and for four weeks, three times a week for the… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Flexibility, Range of Motion
- What is being tested?
- Muscle Stretching Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Apr 2016
- 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 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female;
- Aged between 20 and 30 years;
- Be sedentary as classification of the International Physical Activity Questionnaire (IPAQ);
- Make Use of oral contraceptives;
- Body Mass Index range 18 to 24.
Who cannot join
- Provided history of musculoskeletal injury or surgery of the lower limbs;
- Provide continuous pain in the legs or lower back pain;
- Make use of painkillers, anti-inflammatory and / or muscle relaxant;
- Being in pregnancy;
- Present laxity ligament;
- Achieve zero degrees of extension in Knee Extension Test Modified.
About this study
Official title: Comparison of Four Weeks of Passive Static Stretching and Proprioceptive Neuromuscular Facilitation (PNF) in Musculoskeletal Aspects of the Hamstrings: a Randomized Controlled Trial
This study investigates the influence of two different stretching techniques on the flexibility of the muscles that are in the posterior thigh, after a training period.
The study will last for six weeks where the volunteers need to go to the lab twice for evaluation, and for four weeks, three times a week for the application of stretching training.
Read more
Evaluation before and after the training period consists of applying hip and knee flexibility tests, evaluation of strength, muscle activation and muscle architecture. The Flexibility tests are: (1) Straight Leg Raise Flexibility Test (SLR), where the volunteer will be positioned supine on a stretcher. Then the appraiser will perform hip flexion keeping the knee extended and relaxed foot to the angle at which the person refer discomfort while the contralateral limb remain firmly leaning on the table; (2) Modified Passive knee extension (TEJ), where the volunteer will be positioned supine on a stretcher. The assessor shall determine the hip member to be rated at 90º and perform knee extension to the angle at which the person refer discomfort. The contralateral limb remain firmly leaning on the table.
For the evaluation of muscle strength the volunteer had sat on equipment, makes five repetitions of bending and straightening the knee to familiarize yourself with the equipment and after will make other five replicates doing maximum strength.
To evaluate the electrical activity will be the depilation of the skin with a razor and cleaning with an alcohol swab after adhesive electrodes will be placed for collection of muscle activity, the electrodes do not emit shocks.
The muscle architecture will be assessed via a ultrasound , to its use the use of a water soluble gel to improve the machine's skin contact is required.
For the intervention, the stretching will be held in both legs, where the volunteer will remain lying on a stretcher with fixed trunk with velcro straps and the researcher will carry out the elongation raising the leg drawn to the moment of discomfort the volunteer will refer and will remain for 30 seconds (s) in case he belongs to passive static stretching group, if the stretching group of proprioceptive neuromuscular facilitation, will be in the same position, but before the 30s of stretching, he you will have to push against during 6s to lower leg against the researcher.
If he belongs to the control group, have only two trips to the laboratory for testing, will make an initial assessment and after four weeks will return to perform the tests again, in the period between assessments will not need to go to the lab because it does not make intervention elongation.
It is possible that there discomfort during flexibility testing, strength testing and stretching training. After the tests can still experience muscle pain should disappear within 48 hours. The risks of research are minimal, not exceeding those of a strength training session and stretching.
- Conditions
- Flexibility, Range of Motion
- Being tested
- Muscle Stretching Exercises
- Keywords
- Lower Extremity, Muscle Stretching Exercises, Muscle Strength, Static Stretching, Proprioceptive Neuromuscular Facilitation (PNF) Stretching, Muscle Strength Dynamometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Stretching ExercisesOther
Also called Passive Static Stretching, Proprioceptive neuromuscular facilitation
The training consists of a four-week program of passive stretching exercise with three times week/sessions with interval of 48 hours between them. Each session will consist of carrying out a single repetition of stretching exercise with 30s of duration, static or PNF, according to the group to which voluntary membership. The two lower members receive training but only the lower limb data drawn will be used for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Without intervention |
| Static Group | Experimental | Will receive passive static stretching in hamstring muscle Receives: Other: Muscle Stretching Exercises |
| PNF Group | Experimental | Will receive passive proprioceptive neuromuscular facilitation stretching in hamstring muscle Receives: Other: Muscle Stretching Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Range of motion
Flexibility of the hamstring muscles is defined as the range of motion achieved in the Straight Leg Raising Test and modified Knee Extension Test
Measured: Participants will be followed for the duration of stretching training, an average of six weeks
Secondary outcomes (3)
Change of Force hamstring
Will be referred to as the peak torque (N.m.) isometric, concentric and eccentric isokinetic assessment with a dynamometer isokinetic.
Measured: Participants will be followed for the duration of stretching training, an average of six weeks
Change of Muscle electrical activation
Is defined as the value Root Mean Square (RMS) of the vastus lateralis, rectus femoris and biceps femoris obtained during the tests of muscular strength and flexibility through a Electromyograph.
Measured: Participants will be followed for the duration of stretching training, an average of six weeks
Change of Muscle Architecture
Will be represented through the issue of length and muscle thickness measured by ultrasound.
Measured: Participants will be followed for the duration of stretching training, an average of six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlexibilityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anelize Cini, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478606
- Sponsor's protocol ID
- 1.102.297
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 11 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Four Weeks of Passive Static Stretching and Proprioceptive Neuromuscular Facilitation (PNF) in Musculoskeletal Aspects of the Hamstrings: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02478606
- Acronym / sponsor ID
- 1.102.297
- Conditions
- Flexibility, Range of Motion
- Keywords
- Lower Extremity, Muscle Stretching Exercises, Muscle Strength, Static Stretching, Proprioceptive Neuromuscular Facilitation (PNF) Stretching, Muscle Strength Dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Jun 2015 (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.
This study investigates the influence of two different stretching techniques on the flexibility of the muscles that are in the posterior thigh, after a training period.
The study will last for six weeks where the volunteers need to go to the lab twice for evaluation, and for four weeks, three times a week for the application of stretching training.
Evaluation before and after the training period consists of applying hip and knee flexibility tests, evaluation of strength, muscle activation and muscle architecture. The Flexibility tests are: (1) Straight Leg Raise Flexibility Test (SLR), where the volunteer will be positioned supine on a stretcher. Then the appraiser will perform hip flexion keeping the knee extended and relaxed foot to the angle at which the person refer discomfort while the contralateral limb remain firmly leaning on the table; (2) Modified Passive knee extension (TEJ), where the volunteer will be positioned supine on a stretcher. The assessor shall determine the hip member to be rated at 90º and perform knee extension to the angle at which the person refer discomfort. The contralateral limb remain firmly leaning on the table.
For the evaluation of muscle strength the volunteer had sat on equipment, makes five repetitions of bending and straightening the knee to familiarize yourself with the equipment and after will make other five replicates doing maximum strength.
To evaluate the electrical activity will be the depilation of the skin with a razor and cleaning with an alcohol swab after adhesive electrodes will be placed for collection of muscle activity, the electrodes do not emit shocks.
The muscle architecture will be assessed via a ultrasound , to its use the use of a water soluble gel to improve the machine's skin contact is required.
For the intervention, the stretching will be held in both legs, where the volunteer will remain lying on a stretcher with fixed trunk with velcro straps and the researcher will carry out the elongation raising the leg drawn to the moment of discomfort the volunteer will refer and will remain for 30 seconds (s) in case he belongs to passive static stretching group, if the stretching group of proprioceptive neuromuscular facilitation, will be in the same position, but before the 30s of stretching, he you will have to push against during 6s to lower leg against the researcher.
If he belongs to the control group, have only two trips to the laboratory for testing, will make an initial assessment and after four weeks will return to perform the tests again, in the period between assessments will not need to go to the lab because it does not make intervention elongation.
It is possible that there discomfort during flexibility testing, strength testing and stretching training. After the tests can still experience muscle pain should disappear within 48 hours. The risks of research are minimal, not exceeding those of a strength training session and stretching.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Without intervention |
| Static Group | Experimental | Other: Muscle Stretching ExercisesWill receive passive static stretching in hamstring muscle |
| PNF Group | Experimental | Other: Muscle Stretching ExercisesWill receive passive proprioceptive neuromuscular facilitation stretching in hamstring muscle |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female;
- Aged between 20 and 30 years;
- Be sedentary as classification of the International Physical Activity Questionnaire (IPAQ);
- Make Use of oral contraceptives;
- Body Mass Index range 18 to 24.
Key exclusion criteria (6 listed)
- Provided history of musculoskeletal injury or surgery of the lower limbs;
- Provide continuous pain in the legs or lower back pain;
- Make use of painkillers, anti-inflammatory and / or muscle relaxant;
- Being in pregnancy;
- Present laxity ligament;
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 |
|---|---|---|
| Muscle Stretching ExercisesAlso: Passive Static Stretching, Proprioceptive neuromuscular facilitationThe training consists of a four-week program of passive stretching exercise with three times week/sessions with interval of 48 hours between them. Each session will consist of carrying out a single repetition of stretching exercise with 30s of duration, static or PNF, according to the group to which voluntary membership. The two lower members receive training but only the lower limb data drawn will be used for analysis. | Other | PNF Group, Static Group |
Primary outcome
Change of Range of motion
Time frame: Participants will be followed for the duration of stretching training, an average of six weeks
Flexibility of the hamstring muscles is defined as the range of motion achieved in the Straight Leg Raising Test and modified Knee Extension Test
3 secondary outcomes
Change of Force hamstring
Time frame: Participants will be followed for the duration of stretching training, an average of six weeks
Change of Muscle electrical activation
Time frame: Participants will be followed for the duration of stretching training, an average of six weeks
Change of Muscle Architecture
Time frame: Participants will be followed for the duration of stretching training, an average of six weeks
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 11 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Stretching Exercises in people with Flexibility and Range of Motion, run by Federal University of Rio Grande do Sul.
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 5 inclusion and 6 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 11 May 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?
Change of Range of motion (time frame: Participants will be followed for the duration of stretching training, an average of six weeks). 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 11 May 2016.