Spine InjuryNCT05904834

Effect of a Flexibility Program on the Extensibility of the Hamstrings and the Thoracic and Lumbar Spinal Curvatures

A study testing Flexibility training in people with Spine Injury and Hamstring Injury, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

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 goal of this clinical trial is to analyse the effect of an intervention program based on hamstring flexibility on the extensibility and curvatures of the spine in dancers. Participants will be dance student with ten years of experience that will undergo a program of stretching four times per week during seven… Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Spine Injury, Hamstring Injury, Lumbar Hyperlordosis
What is being tested?: Flexibility training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteSpain
Study dates: 9 Jan 2023to 22 Dec 2023
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 Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Not attending at least 80% of the practical sessions of the Conservatory throughout the programme;
being pregnant at the beginning of the study or getting pregnant during the development of the study;
having undergone surgery on the spine or hamstring musculature;
having suffered a hamstring injuries in the last year or during the study;
having structured spinal disorders;
having an injury at the time of the assessment that prevents her from taking the measurements;
stretching of the hamstring musculature outside the conservatory.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad Católica San Antonio
Murcia, 30107

Other trials in Spain

About this study

The goal of this clinical trial is to analyse the effect of an intervention program based on hamstring flexibility on the extensibility and curvatures of the spine in dancers.

Participants will be dance student with ten years of experience that will undergo a program of stretching four times per week during seven weeks, followed by a detraining period, and a retraining period of three weeks. There will be a pre-test, a post-test and two re-tests after the intervention.

The results will be compared with a control group of dancers that will not take part in the stretching program.

Read the detailed description

Four measurements were carried out, one before the intervention (pre-test), one after the first stretching programme (post-test), one after a short period of detraining (re-test 1) and the last one at the end of a second period of intervention (re-test 2), analysing the intra-group and inter-group differences for each of the dependent variables.

The sample components (n=61) were divided into two groups following a random distribution carried out by an external researcher. The intervention group (IG), which consisted of 31 dancers, underwent the hamstring stretching programme for a first period of 7 weeks and a second period of 3 weeks after a short period of detraining. The intervention consisted of static and dynamic stretching of the hamstring muscles 4 days per week. The control group (CG), composed of 30 dancers, did not perform the stretching programme. Both groups attended their practical classes in the conservatory. During the detraining period the dancers of both groups took a break from physical exercise.

The variables measured are hamstring extensibility and sagittal spine disposition and pelvic tilt.

Conditions: Spine Injury, Hamstring Injury, Lumbar Hyperlordosis, Kyphosis
Being tested: Flexibility training
Keywords: Flexibility training, Dancers, Ballet, Flexibility testing
Medical subject headings: Spinal Injuries, Swayback, Kyphosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flexibility trainingOther
Each session consisted of three or four exercises, of which three were static stretches and if there was a fourth, it was dynamic. The duration of each exercise was 20 seconds with 15 seconds rest between sets and 30 seconds rest between exercises.

Study groups in NCT05904834
Study group	Role	What they receive
Flexibility training	Experimental	The intervention group will undergo a flexibility training focused on hamstring extensibility. Each will they will take part in four stretching sessions besides the normal dance training. Receives: Other: Flexibility training
No training	No intervention	The control group will continue with their training routine during the experiment.

What is being measured

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

Linear hamstring flexibility
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Measured: Pre-test (week 1)
Linear hamstring flexibility
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Measured: Post-test (week 8)
Linear hamstring flexibility
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Measured: Re-test 1 (week 11)
Linear hamstring flexibility
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Measured: Re-test 2 (week 14)
Angular hamstring flexibility
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Measured: Pre-test (week 1)
Angular hamstring flexibility
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Measured: Post-test (week 8)
Angular hamstring flexibility
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Measured: Re-test 1 (week 11)
Angular hamstring flexibility
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Measured: Re-test 2 (week 14)
Thoracic spinal curvatures
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Pre-test (week 1)
Thoracic spinal curvatures
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Post-test (week 8)
Thoracic spinal curvatures
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Re-test 1 (week 11)
Thoracic spinal curvatures
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Re-test 2 (month 14)
Lumbar thoracic spinal curvatures
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Pre-test (week 1)
Lumbar thoracic spinal curvatures
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Post-test (Week 8)
Lumbar thoracic spinal curvatures
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Re-test 1 (week 11)
Lumbar thoracic spinal curvatures
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Re-test 2 (Week 14)
Pelvic Tilt
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Pre-test (week 1)
Pelvic Tilt
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Post-test (Week 8)
Pelvic Tilt
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Re-test 1 (week 11)
Pelvic Tilt
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Measured: Re-test 2 (Week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 202322 Dec 2023

First posted15 Jun 2023
Study start9 Jan 2023
Primary completion31 May 2023
Study completion22 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spine InjuryStudies 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
Model description: Single intervention group and single control group
Masking: Single blind
Who is masked: Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05904834
Sponsor's protocol ID: 20092013
Status last verified: Jun 2024
First submitted: 22 May 2023
Last updated: 6 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Personal information is not going to be shared under any circumstances. Only unidentified and impersonal information will be used.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Flexibility Program on the Extensibility of the Hamstrings and the Thoracic and Lumbar Spinal Curvatures
ClinicalTrials.gov ID: NCT05904834
Acronym / sponsor ID: 20092013
Conditions: Spine Injury, Hamstring Injury, Lumbar Hyperlordosis, Kyphosis
Keywords: Flexibility training, Dancers, Ballet, Flexibility testing
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Universidad Católica San Antonio de MurciaUniversity, hospital or other
Study start: 9 Jan 2023 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 22 Dec 2023 (actual)
First posted: 15 Jun 2023 (actual)
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 goal of this clinical trial is to analyse the effect of an intervention program based on hamstring flexibility on the extensibility and curvatures of the spine in dancers.

The results will be compared with a control group of dancers that will not take part in the stretching program.

Detailed description

The variables measured are hamstring extensibility and sagittal spine disposition and pelvic tilt.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Single intervention group and single control group

Arm	Type	Receives
Flexibility training	Experimental	Other: Flexibility trainingThe intervention group will undergo a flexibility training focused on hamstring extensibility. Each will they will take part in four stretching sessions besides the normal dance training.
No training	No intervention	–The control group will continue with their training routine during the experiment.

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (7 listed)

Not attending at least 80% of the practical sessions of the Conservatory throughout the programme;
being pregnant at the beginning of the study or getting pregnant during the development of the study;
having undergone surgery on the spine or hamstring musculature;
having suffered a hamstring injuries in the last year or during the study;
having structured spinal disorders;

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
Flexibility trainingEach session consisted of three or four exercises, of which three were static stretches and if there was a fourth, it was dynamic. The duration of each exercise was 20 seconds with 15 seconds rest between sets and 30 seconds rest between exercises.	Other	Flexibility training

Primary outcome

Linear hamstring flexibility
Time frame: Pre-test (week 1)
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Linear hamstring flexibility
Time frame: Post-test (week 8)
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Linear hamstring flexibility
Time frame: Re-test 1 (week 11)
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Linear hamstring flexibility
Time frame: Re-test 2 (week 14)
The flexibility of the hamstring will be assessed with different linear test. Sit and reach test will be performed and the measure will be reported in centimeters
Angular hamstring flexibility
Time frame: Pre-test (week 1)
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Angular hamstring flexibility
Time frame: Post-test (week 8)
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Angular hamstring flexibility
Time frame: Re-test 1 (week 11)
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Angular hamstring flexibility
Time frame: Re-test 2 (week 14)
The flexibility of the hamstring will be assessed with angular tests. Straight leg raise will be performed in the active and passive versions and the result will be reported in grades
Thoracic spinal curvatures
Time frame: Pre-test (week 1)
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Thoracic spinal curvatures
Time frame: Post-test (week 8)
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Thoracic spinal curvatures
Time frame: Re-test 1 (week 11)
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Thoracic spinal curvatures
Time frame: Re-test 2 (month 14)
The thoracic spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Lumbar thoracic spinal curvatures
Time frame: Pre-test (week 1)
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Lumbar thoracic spinal curvatures
Time frame: Post-test (Week 8)
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Lumbar thoracic spinal curvatures
Time frame: Re-test 1 (week 11)
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Lumbar thoracic spinal curvatures
Time frame: Re-test 2 (Week 14)
The lumbar spinal curvatures will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Pelvic Tilt
Time frame: Pre-test (week 1)
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Pelvic Tilt
Time frame: Post-test (Week 8)
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Pelvic Tilt
Time frame: Re-test 1 (week 11)
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.
Pelvic Tilt
Time frame: Re-test 2 (Week 14)
The pelvic tilt will be assessed in different positions, including relaxed standing, the sit and reach test and Macrae \& Wright test. The result will be reported in grades.

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 6 Jun 2024.
Individual participant dataSharing planned: No. Personal information is not going to be shared under any circumstances. Only unidentified and impersonal information will be used.

Related trials for Spine Injury

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Flexibility training in people with Spine Injury and Hamstring Injury, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

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 0 inclusion and 7 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Linear hamstring flexibility (time frame: Pre-test (week 1)). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05904834.

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 6 Jun 2024.