Resistance TrainingNCT03862560
Evaluation of Physical Performance and Functional Asymmetries in Female Football
A study testing Strength training program in people with Resistance Training and Inter-limb Asymmetries, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Worldwide, soccer has grown increasingly popular among female players. According to the Women´s Football Survey of the Fédération Internationale de Football Association (FIFA), there were more than 30 million registered women soccer players in 2014. Read more about this study
- Who is it for?
- Ages 12 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Resistance Training, Inter-limb Asymmetries, Athletic Performance
- What is being tested?
- Strength training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2017to 1 Jul 2018
- 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 12 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Caucasian, Healthy participant, from 12 to 20 years old, with a history of training at least 3 years.
Who cannot join
- Non-caucasian, injury.
Trial locations and contacts
1 site in 1 country.
Spain1 site
GENUD Research group (Growth, Exercise, NUtrition and Development)
Zaragoza
About this study
Official title: Evaluación Del Rendimiento físico y asimetrías Funcionales en el fútbol Femenino
Worldwide, soccer has grown increasingly popular among female players. According to the Women´s Football Survey of the Fédération Internationale de Football Association (FIFA), there were more than 30 million registered women soccer players in 2014. Elite female soccer players cover approximately a total distance of 10 km with 1.7 km completed at high-speed (>18 km/h-1), between 1350 and 1650 changes of activity like passing, dribbling, tackling and trapping and 5.1 and 31.2 repeated sprinting and high intensity bouts, respectively. Thus, it seems that those strategies addressed to improve such high-intensity activities should be considered a priority for female soccer players.
Different training methods to improve soccer specific variables have been developed such as, high-intensity interval training, resisted sprint training, strength training or plyometric training. Whilst individual training interventions have been shown to produce enhancements in measures of athletic performance for soccer players, there is a paucity of studies looking at the effectiveness of strength and power training specifically on performance measures in female soccer populations.
Read more
Unilateral strength asymmetry can be a risk factor of musculoskeletal injuries. In recent years, inter-limb asymmetries have been included in battery tests performed by different soccer clubs due to their relation with lower-limb injuries. Few studies have analysed the change of an intervention on inter-limb asymmetry in female soccer players, hence, more studies for this population are warranted.
The main aim of this research project is therefore, to evaluate the effect of a physical intervention on the performance and inter-limb asymmetries of female soccer players.
- Being tested
- Strength training program
- Keywords
- Soccer, Female, Lower limb asymmetries, Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training programOther
Strength training program in female soccer players
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Female soccers that perform a strength training Receives: Other: Strength training program |
| Control group | No intervention | Female soccers that do not perform a strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jumping in centimeters
Jumping height was assessed using a vertical countermovement jump, drop jump and standing broad jump with flight.
Measured: Change from baseline in jumping height at 12 weeks
Velocity in seconds
Running speed was evaluated by a 40-m sprint time (standing start) with 10-m, 20-m, 30-m split times.
Measured: Change from baseline in velocity at 12 weeks
Change of direction in seconds
Change of direction ability was assessed by 180º change of direction and V-cut tests.
Measured: Change from Baseline in change of direction at 12 weeks
Inter-limb asymmetry in %
Inter-limb asymmetry was calculated using the following formula : Inter-limb asymmetry = 100/Max Value (right and left)*Min Value (right and left)*-1+100.
Measured: Change from Baseline in inter-limb asymmetry at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jul 2017
- Primary completion31 May 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Resistance TrainingStudies 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
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José A. Casajús, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862560
- Sponsor's protocol ID
- C.P. - C.I. PI19/039
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoff J, Helgerud J. Endurance and strength training for soccer players: physiological considerations. Sports Med. 2004;34(3):165-80. doi: 10.2165/00007256-200434030-00003.
PubMed 14987126Olsen OE, Myklebust G, Engebretsen L, Holme I, Bahr R. Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial. BMJ. 2005 Feb 26;330(7489):449. doi: 10.1136/bmj.38330.632801.8F. Epub 2005 Feb 7.
PubMed 15699058Brumitt J, Heiderscheit BC, Manske RC, Niemuth PE, Rauh MJ. Lower extremity functional tests and risk of injury in division iii collegiate athletes. Int J Sports Phys Ther. 2013 Jun;8(3):216-27.
PubMed 23772338Kiani A, Hellquist E, Ahlqvist K, Gedeborg R, Michaelsson K, Byberg L. Prevention of soccer-related knee injuries in teenaged girls. Arch Intern Med. 2010 Jan 11;170(1):43-9. doi: 10.1001/archinternmed.2009.289.
PubMed 20065198
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación Del Rendimiento físico y asimetrías Funcionales en el fútbol Femenino
- ClinicalTrials.gov ID
- NCT03862560
- Acronym / sponsor ID
- C.P. - C.I. PI19/039
- Keywords
- Soccer, Female, Lower limb asymmetries, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 5 Mar 2019 (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.
Worldwide, soccer has grown increasingly popular among female players. According to the Women´s Football Survey of the Fédération Internationale de Football Association (FIFA), there were more than 30 million registered women soccer players in 2014. Elite female soccer players cover approximately a total distance of 10 km with 1.7 km completed at high-speed (>18 km/h-1), between 1350 and 1650 changes of activity like passing, dribbling, tackling and trapping and 5.1 and 31.2 repeated sprinting and high intensity bouts, respectively. Thus, it seems that those strategies addressed to improve such high-intensity activities should be considered a priority for female soccer players.
Different training methods to improve soccer specific variables have been developed such as, high-intensity interval training, resisted sprint training, strength training or plyometric training. Whilst individual training interventions have been shown to produce enhancements in measures of athletic performance for soccer players, there is a paucity of studies looking at the effectiveness of strength and power training specifically on performance measures in female soccer populations.
Unilateral strength asymmetry can be a risk factor of musculoskeletal injuries. In recent years, inter-limb asymmetries have been included in battery tests performed by different soccer clubs due to their relation with lower-limb injuries. Few studies have analysed the change of an intervention on inter-limb asymmetry in female soccer players, hence, more studies for this population are warranted.
The main aim of this research project is therefore, to evaluate the effect of a physical intervention on the performance and inter-limb asymmetries of female soccer players.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Strength training programFemale soccers that perform a strength training |
| Control group | No intervention | –Female soccers that do not perform a strength training |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Caucasian, Healthy participant, from 12 to 20 years old, with a history of training at least 3 years.
Key exclusion criteria (1 listed)
- Non-caucasian, injury.
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 |
|---|---|---|
| Strength training programStrength training program in female soccer players | Other | Experimental group |
Primary outcome
Jumping in centimeters
Time frame: Change from baseline in jumping height at 12 weeks
Jumping height was assessed using a vertical countermovement jump, drop jump and standing broad jump with flight.
Velocity in seconds
Time frame: Change from baseline in velocity at 12 weeks
Running speed was evaluated by a 40-m sprint time (standing start) with 10-m, 20-m, 30-m split times.
Change of direction in seconds
Time frame: Change from Baseline in change of direction at 12 weeks
Change of direction ability was assessed by 180º change of direction and V-cut tests.
Inter-limb asymmetry in %
Time frame: Change from Baseline in inter-limb asymmetry at 12 weeks
Inter-limb asymmetry was calculated using the following formula : Inter-limb asymmetry = 100/Max Value (right and left)*Min Value (right and left)*-1+100.
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 5 Mar 2019.
- Results publication: PubMed 14987126Hoff J, Helgerud J. Endurance and strength training for soccer players: physiological considerations. Sports Med. 2004;34(3):165-80. doi: 10.2165/00007256-200434030-00003.
- Results publication: PubMed 15699058Olsen OE, Myklebust G, Engebretsen L, Holme I, Bahr R. Exercises to prevent lower limb injuries in youth sports: cluster randomised controlled trial. BMJ. 2005 Feb 26;330(7489):449. doi: 10.1136/bmj.38330.632801.8F. Epub 2005 Feb 7.
- Results publication: PubMed 23772338Brumitt J, Heiderscheit BC, Manske RC, Niemuth PE, Rauh MJ. Lower extremity functional tests and risk of injury in division iii collegiate athletes. Int J Sports Phys Ther. 2013 Jun;8(3):216-27.
- Results publication: PubMed 20065198Kiani A, Hellquist E, Ahlqvist K, Gedeborg R, Michaelsson K, Byberg L. Prevention of soccer-related knee injuries in teenaged girls. Arch Intern Med. 2010 Jan 11;170(1):43-9. doi: 10.1001/archinternmed.2009.289.
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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 Strength training program in people with Resistance Training and Inter-limb Asymmetries, run by Universidad de Zaragoza 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 1 inclusion and 1 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 5 Mar 2019. 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?
Jumping in centimeters (time frame: Change from baseline in jumping height at 12 weeks). The study lists 4 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 NCT03862560, which also lists 4 linked publications.
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 Mar 2019.