RugbyNCT04285645
Preheating in the Improvement of Knee Stability and Quadriceps Strength in Rugby Players
A study testing Warmup in people with Rugby, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Injuries to the lower limbs are the most common in rugby and within the lower limbs, the most common are those that affect the ligaments of the knee. That is why we will try to improve knee stability and quadriceps strength. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rugby
- What is being tested?
- Warmup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 10 Jun 2020
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female rugby players
- With an age range of 18 to 30 years
- That participate in the Valencian territorial category 1
- Without diagnosis of lower limb injury at the time of starting the study
Who cannot join
- Players who suffer an injury or illness that prevents them from performing the protocol
- Are performing another specific physiotherapy program of knee stability and quadriceps strength
- Who had undergone the anterior cruciate ligament less than a year ago
- Have not signed the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Protocol Through Preheating in the Improvement of Knee Stability and Quadriceps Strength in Rugby Players. A Randomized Clinical Study.
Injuries to the lower limbs are the most common in rugby and within the lower limbs, the most common are those that affect the ligaments of the knee. That is why we will try to improve knee stability and quadriceps strength.
The aim of this study is to evaluate the effectiveness of performing a pre-workout exercise protocol to improve knee stability and quadriceps strength in rugby players.
Read more
Randomized controlled study, simple blind and with follow-up. 30 semi-professional rugby players will be randomized to the two study groups: experimental (pre-training exercise protocol that will include continuous running, squats, and squats and monopodal jumps) and control (without intervention). The intervention will last 4 weeks, with 2 weekly sessions of 15 minutes each. The study variables will be: knee stability (Y-Balance) and quadriceps strength (Single leg hop). The sample distribution will be calculated using the Kolmogorov-Smirnov test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
It is expected to see improvement in knee stability and quadriceps strength in athletes who performed the exercise protocol, after the study period.
- Conditions
- Rugby
- Being tested
- Warmup
- Keywords
- Rugby, Injury, Knee, Stability, Strength Training
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarmupOther
Also called Experimental group
The intervention through exercises will consist in the application of the protocol described by Waldén et al. The objective of the application of this exercise protocol is to produce an improvement in the stability of the knee and the strength of the quadriceps. Before carrying out the exercises, a continuous race will be carried out for 5 minutes, once this first step is finished we will proceed to the realization of the exercises that will be, squats with both legs placing the hands on the hips, feet placed at the width of the shoulders, lowering with a straight back and without raising the heels of the floor, 3 series of 15 repetitions, squats on one leg with the hands on the hips and leg not supported extended forward, 3 sets of 10 repetitions with each leg and jump forward with one leg with the hands on the hips and jump back to return to the starting position, 3 sets of 10 repetitions with each leg
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Each session will last 15 minutes, taking place 2 days a week, over a period of 4 weeks. Prior to training, the exercise protocol will be carried out. Prior to the start of the intervention, the exercises to be performed will be explained to the participants and it will be verified that they are capable of performing them correctly. Receives: Other: Warmup |
| Control group | No intervention | Athletes included in the control group will continue with their usual training routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline knee stability after treatment and at month
It will be done using the Y-Balance test. The barefoot sportswoman will be placed with the toes in the center of the Y marked on the floor with adhesive tape. Each of them will have six trials with each foot in each direction (anterior, posterolateral and posteromedial). Subsequently, they will have three attempts with each leg in each direction, taking the best mark of each leg in each direction. The athlete must return to the initial position without losing balance, because if she does not succeed, that attempt will be void. The distance to be measured includes from the central mark where we place the toes to the point where the patient supports the tip of the toes. The unit of measure of this measuring instrument is the centimeter. A higher score indicates greater knee stability.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (1)
Change from baseline quadriceps strength after treatment and at month
It will be done by applying the Single leg hop test. With this test, the quadriceps strength will be measured. With the patient in monopodal and barefoot support, and with the toes placed on a mark made on the floor with adhesive tape, he will make a leap forward, maintaining the balance at least one second. Each player will perform 6 warm-up jumps with each leg. Subsequently you will have three attempts with each leg and the greatest distance achieved with each one will be taken. The distance will be measured from the initial mark, to where the subject's heel lands, with cm being the unit of measure for the test. A greater distance indicates a greater force of quadriceps.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Mar 2020
- Primary completion20 May 2020
- Study completion10 Jun 2020
Why it stopped: COVID-19 Lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RugbyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285645
- Sponsor's protocol ID
- Stability
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Protocol Through Preheating in the Improvement of Knee Stability and Quadriceps Strength in Rugby Players. A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04285645
- Acronym / sponsor ID
- Stability
- Conditions
- Rugby
- Keywords
- Rugby, Injury, Knee, Stability, Strength Training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 Lockdown
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 26 Feb 2020 (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.
Injuries to the lower limbs are the most common in rugby and within the lower limbs, the most common are those that affect the ligaments of the knee. That is why we will try to improve knee stability and quadriceps strength.
The aim of this study is to evaluate the effectiveness of performing a pre-workout exercise protocol to improve knee stability and quadriceps strength in rugby players.
Randomized controlled study, simple blind and with follow-up. 30 semi-professional rugby players will be randomized to the two study groups: experimental (pre-training exercise protocol that will include continuous running, squats, and squats and monopodal jumps) and control (without intervention). The intervention will last 4 weeks, with 2 weekly sessions of 15 minutes each. The study variables will be: knee stability (Y-Balance) and quadriceps strength (Single leg hop). The sample distribution will be calculated using the Kolmogorov-Smirnov test. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.
It is expected to see improvement in knee stability and quadriceps strength in athletes who performed the exercise protocol, after the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: WarmupEach session will last 15 minutes, taking place 2 days a week, over a period of 4 weeks. Prior to training, the exercise protocol will be carried out. Prior to the start of the intervention, the exercises to be performed will be explained to the participants and it will be verified that they are capable of performing them correctly. |
| Control group | No intervention | –Athletes included in the control group will continue with their usual training routine. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female rugby players
- With an age range of 18 to 30 years
- That participate in the Valencian territorial category 1
- Without diagnosis of lower limb injury at the time of starting the study
Key exclusion criteria (4 listed)
- Players who suffer an injury or illness that prevents them from performing the protocol
- Are performing another specific physiotherapy program of knee stability and quadriceps strength
- Who had undergone the anterior cruciate ligament less than a year ago
- Have not signed the informed consent.
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 |
|---|---|---|
| WarmupAlso: Experimental groupThe intervention through exercises will consist in the application of the protocol described by Waldén et al. The objective of the application of this exercise protocol is to produce an improvement in the stability of the knee and the strength of the quadriceps. Before carrying out the exercises, a continuous race will be carried out for 5 minutes, once this first step is finished we will proceed to the realization of the exercises that will be, squats with both legs placing the hands on the hips, feet placed at the width of the shoulders, lowering with a straight back and without raising the heels of the floor, 3 series of 15 repetitions, squats on one leg with the hands on the hips and leg not supported extended forward, 3 sets of 10 repetitions with each leg and jump forward with one leg with the hands on the hips and jump back to return to the starting position, 3 sets of 10 repetitions with each leg | Other | Experimental group |
Primary outcome
Change from baseline knee stability after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
It will be done using the Y-Balance test. The barefoot sportswoman will be placed with the toes in the center of the Y marked on the floor with adhesive tape. Each of them will have six trials with each foot in each direction (anterior, posterolateral and posteromedial). Subsequently, they will have three attempts with each leg in each direction, taking the best mark of each leg in each direction. The athlete must return to the initial position without losing balance, because if she does not succeed, that attempt will be void. The distance to be measured includes from the central mark where we place the toes to the point where the patient supports the tip of the toes. The unit of measure of this measuring instrument is the centimeter. A higher score indicates greater knee stability.
1 secondary outcome
Change from baseline quadriceps strength after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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 Warmup in people with Rugby, run by Investigación en Hemofilia y Fisioterapia 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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 from baseline knee stability after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 5 Sep 2021.