HealthyNCT04738617
Inter- and Intra-individual Variation in Acute Responses to Two Different Warm-up Types.
A study testing Inter and intra-individual variation in acute responses to two different warm-up types in people with Healthy, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The goal is to assess inter- and intraindividual variation in response to different warm-up protocols in a randomized, cross-over study with U16 and U17 Portuguese soccer players. Read more about this study
- Who is it for?
- Ages 14 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inter and intra-individual variation in acute responses to two different warm-up types
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2023to 1 Sep 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 14 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants will be 40 to 50 healthy football players from the U16 and U17 teams of a club from the Oporto city, engaged in three weekly training sessions with an average weekly training volume of 270 minutes.
Who cannot join
- Following similar research (Beato, De Keijzer, et al., 2019), participants will have to be free from injuries or illness at the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inter- and Intra-individual Variation in Acute Responses to Two Different Warm-up Types. A Randomized Crossover Trial With U16 and U17 Football Players
The goal is to assess inter- and intraindividual variation in response to different warm-up protocols in a randomized, cross-over study with U16 and U17 Portuguese soccer players.
Read the detailed description
Trial design We are following the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement: extension to randomized crossover trials (Dwan, Li, Altman, \& Elbourne, 2019). Randomized crossover designs increasing statistical power, as participants act as their own controls (Dwan et al., 2019). Here, a randomized crossover design with two arms is elaborated. A two-week familiarization period with the two interventions and with testing will be performed, during which the participants will make four visits, in all of which they will go through pre-testing, protocols A and B (on alternate days), followed by post-testing. This period will be followed by two-weeks of performing each intervention, separated by a two-week wash-out period to avoid a carryover effect (Higgins et al., 2019), which is superior to that used in similar research (Barbosa et al., 2019). In each period, the groups will perform four visits in terms of intervention, and in two of those visits they will be tested with the goal of assessing within-group, within-intervention consistency. Allocation ratio will be ~1:1. The protocol will be sent to approved by the Ethics Committee of the Faculty of Sport of the University Porto, and then registered at http://www.clinicaltrials.gov. Participants will be informed of the goals and methods of the research and their legal tutors will sign informed consent forms (as they will be <18 years-old), following the updated version (2013) of the Declaration of Helsinki.
Participants Participants will be 40 to 50 healthy football players from the U16 and U17 teams of a club from the Oporto city, engaged in three weekly training sessions with an average weekly training volume of 270 minutes. Following similar research (Beato, De Keijzer, et al., 2019), participants will have to be free from injuries or illness at the start of the study. Data will be collected in the facilities of the club where the participants play, and therefore no familiarization to the environment will be required.
Interventions In line with previous research (Beato, De Keijzer, et al., 2019; Faude, Roth, Di Giovine, Zahner, \& Donath, 2013), a 10-minute general warm-up will precede the implementation of the specific warm-up protocols. The general warm-up will consist of three minutes running at low to moderated intensity, followed by three minutes of active, dynamic mobility work, followed by approximately four minutes of 20-m accelerations at 70% of maximum perceived intensity, where each player will perform 5 repetitions of increasing distances (i.e., 10 m, 15 m, 20 m, 25 m, 30 m). During the pre-tests, general warm-up, interventions and post-tests, players will wear Global Positioning System (GPS, VX Sport, Model VXLOG 175).
The interventions will consist of two different warm-up strategies. In the first two weeks of implementation, one group will perform intervention A while the other will perform intervention B. After the wash-out period, the groups will crossover (AB/BA design). In each two-week period of the interventions, the participants will make two weekly visits, in a total of four visits per period. In the first visit of each week, the participants will only perform the interventions, while in the second visit of each week, the participants will also engage in pre- and post-testing. Therefore, two tests per period will be applied.
Intervention A is based on football-specific small-sided games (SSGs), consisting of 4 versus 4 matches (with mini-goals), performed in a 30 m by 24 m court (Giménez et al., 2018), using five sets of 90 seconds of work interspersed with 30 seconds of pause, in a total duration of 10 minutes. Intervention B is based on speed, COD and plyometrics (i.e., a "potentiation" protocol), inspired by ideas presented by Howe, Coward, and Price (2017). Participants will perform five repetitions of the following exercises, in this order: unilateral hurdle hops and lateral hurdle hops with each lower limb; countermovement jump; broad jump; forward in and out; slalom jumps; lateral scissor jumps; single leg linear hops. Each intervention will last ~10 minutes and will be applied in the football field. Two experienced football coaches with a degree in Sports Sciences will deliver and monitor all the sessions. The interventions were designed to be easily applicable by coaches without the need for sophisticated facilities or material. All interventions will be implemented at the same time of the day and in the same days of the week for both groups. Due to the nature of the interventions, participants and implementers will not be blinded.
Sample size The software G*Power (version 3.1.9.6. for Mac) was used to assess a priori sample power. Considering a repeated-measures ANOVA, for within factors, with a power of 0.95, α = 0.05, correlation coefficient of 0.5, non-sphericity correction of 1, effect size of 0.35, two groups and four measures (i.e., outcomes), minimum sample size was established in 20 subjects. For also analyzing within-between interactions, 36 subjects were required, which is still below our estimated sample of 40-50 participants.
Randomization In this crossover study, some athletes will perform an AB sequence, while others will perform a BA sequence. It is predetermined that each group will have ~50% of the participants, without any further rules being stipulated for randomization. Randomization will be performed only after the two-week familiarization periods and the pre-tests. The random allocation sequence will be performed by a researcher not involved in testing or in monitoring the interventions. Two opaque bags will be used: (i) the first bag containing folded papers with the names of the participants; (ii) the second bag containing the intervention (i.e., A or B). In each round, the researcher will remove a paper from the second bag, followed by a paper from the first bag. Allocation will be concealed from all other researchers until the start of the intervention. The two main testers will not be provided with this information, to ensure they remain blinded. If allocation suggests problems with baseline values, creating imbalances in the groups with respect to the values obtained in the four tests, the randomization process will be repeated.
- Conditions
- Healthy
- Being tested
- Inter and intra-individual variation in acute responses to two different warm-up types
- Keywords
- warm-up, potentiation, variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inter and intra-individual variation in acute responses to two different warm-up typesBehavioural
Comparison of the acute effects of two different warm-up protocols on subsequent performance.
| Study group | Role | What they receive |
|---|---|---|
| Warm-up based on small-sided games | Experimental | Intervention A is based on football-specific small-sided games (SSGs), consisting of 4 versus 4 matches (with mini-goals), performed in a 30 m by 24 m court (Giménez et al., 2018), using five sets of 90 seconds of work interspersed with 30 seconds of pause, in a total duration of 10 minutes. Receives: Behavioral: Inter and intra-individual variation in acute responses to two different warm-up types |
| Warm-up based on potentiation principles (e.g., speed, change of direction, plyometrics) | Experimental | Intervention B is based on speed, COD and plyometrics (i.e., a "potentiation" protocol), inspired by ideas presented by Howe, Coward, and Price (2017). Participants will perform five repetitions of the following exercises, in this order: unilateral hurdle hops and lateral hurdle hops with each lower limb; CMJ; broad jump; forward in and out; slalom jumps; lateral scissor jumps; single leg linear hops. Each intervention will last ~10 minutes and will be applied in the football field. Receives: Behavioral: Inter and intra-individual variation in acute responses to two different warm-up types |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear speed
Straight line sprinting (20-m linear sprinting test)
Measured: Through study completion (8 weeks)
Pre-programmed change-of-direction
Illinois Agility Test (IAT) without ball and with ball (IATB)
Measured: Through study completion (8 weeks)
Lower limb power
Countermovement jump height
Measured: Through study completion (8 weeks)
Secondary outcomes (1)
Harms and/or side-effects
Systematic register of any harms or side-effect reported during the interventions
Measured: Through study completion (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jan 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Why it stopped: After several postponements due to different reasons (e.g., COVID lockdowns, mismatch between research team availability and club's availability), this study will no longer be performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two weeks of familiarization with protocols and testing. Then, randomization with cross-over design. Two weeks of intervention, followed by two weeks of wash-out, followed by two weeks of intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Afonso Coelho Neves, Universidade do Porto
- Investigators
- José Afonso, Ph.D., Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738617
- Sponsor's protocol ID
- CEFADE 03 2021
- Status last verified
- May 2023
- First submitted
- 30 Jan 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter- and Intra-individual Variation in Acute Responses to Two Different Warm-up Types. A Randomized Crossover Trial With U16 and U17 Football Players
- ClinicalTrials.gov ID
- NCT04738617
- Acronym / sponsor ID
- CEFADE 03 2021
- Conditions
- Healthy
- Keywords
- warm-up, potentiation, variability
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: After several postponements due to different reasons (e.g., COVID lockdowns, mismatch between research team availability and club's availability), this study will no longer be performed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 4 Feb 2021 (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 is to assess inter- and intraindividual variation in response to different warm-up protocols in a randomized, cross-over study with U16 and U17 Portuguese soccer players.
Detailed description
Trial design We are following the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement: extension to randomized crossover trials (Dwan, Li, Altman, \& Elbourne, 2019). Randomized crossover designs increasing statistical power, as participants act as their own controls (Dwan et al., 2019). Here, a randomized crossover design with two arms is elaborated. A two-week familiarization period with the two interventions and with testing will be performed, during which the participants will make four visits, in all of which they will go through pre-testing, protocols A and B (on alternate days), followed by post-testing. This period will be followed by two-weeks of performing each intervention, separated by a two-week wash-out period to avoid a carryover effect (Higgins et al., 2019), which is superior to that used in similar research (Barbosa et al., 2019). In each period, the groups will perform four visits in terms of intervention, and in two of those visits they will be tested with the goal of assessing within-group, within-intervention consistency. Allocation ratio will be ~1:1. The protocol will be sent to approved by the Ethics Committee of the Faculty of Sport of the University Porto, and then registered at http://www.clinicaltrials.gov. Participants will be informed of the goals and methods of the research and their legal tutors will sign informed consent forms (as they will be <18 years-old), following the updated version (2013) of the Declaration of Helsinki.
Participants Participants will be 40 to 50 healthy football players from the U16 and U17 teams of a club from the Oporto city, engaged in three weekly training sessions with an average weekly training volume of 270 minutes. Following similar research (Beato, De Keijzer, et al., 2019), participants will have to be free from injuries or illness at the start of the study. Data will be collected in the facilities of the club where the participants play, and therefore no familiarization to the environment will be required.
Interventions In line with previous research (Beato, De Keijzer, et al., 2019; Faude, Roth, Di Giovine, Zahner, \& Donath, 2013), a 10-minute general warm-up will precede the implementation of the specific warm-up protocols. The general warm-up will consist of three minutes running at low to moderated intensity, followed by three minutes of active, dynamic mobility work, followed by approximately four minutes of 20-m accelerations at 70% of maximum perceived intensity, where each player will perform 5 repetitions of increasing distances (i.e., 10 m, 15 m, 20 m, 25 m, 30 m). During the pre-tests, general warm-up, interventions and post-tests, players will wear Global Positioning System (GPS, VX Sport, Model VXLOG 175).
The interventions will consist of two different warm-up strategies. In the first two weeks of implementation, one group will perform intervention A while the other will perform intervention B. After the wash-out period, the groups will crossover (AB/BA design). In each two-week period of the interventions, the participants will make two weekly visits, in a total of four visits per period. In the first visit of each week, the participants will only perform the interventions, while in the second visit of each week, the participants will also engage in pre- and post-testing. Therefore, two tests per period will be applied.
Intervention A is based on football-specific small-sided games (SSGs), consisting of 4 versus 4 matches (with mini-goals), performed in a 30 m by 24 m court (Giménez et al., 2018), using five sets of 90 seconds of work interspersed with 30 seconds of pause, in a total duration of 10 minutes. Intervention B is based on speed, COD and plyometrics (i.e., a "potentiation" protocol), inspired by ideas presented by Howe, Coward, and Price (2017). Participants will perform five repetitions of the following exercises, in this order: unilateral hurdle hops and lateral hurdle hops with each lower limb; countermovement jump; broad jump; forward in and out; slalom jumps; lateral scissor jumps; single leg linear hops. Each intervention will last ~10 minutes and will be applied in the football field. Two experienced football coaches with a degree in Sports Sciences will deliver and monitor all the sessions. The interventions were designed to be easily applicable by coaches without the need for sophisticated facilities or material. All interventions will be implemented at the same time of the day and in the same days of the week for both groups. Due to the nature of the interventions, participants and implementers will not be blinded.
Sample size The software G*Power (version 3.1.9.6. for Mac) was used to assess a priori sample power. Considering a repeated-measures ANOVA, for within factors, with a power of 0.95, α = 0.05, correlation coefficient of 0.5, non-sphericity correction of 1, effect size of 0.35, two groups and four measures (i.e., outcomes), minimum sample size was established in 20 subjects. For also analyzing within-between interactions, 36 subjects were required, which is still below our estimated sample of 40-50 participants.
Randomization In this crossover study, some athletes will perform an AB sequence, while others will perform a BA sequence. It is predetermined that each group will have ~50% of the participants, without any further rules being stipulated for randomization. Randomization will be performed only after the two-week familiarization periods and the pre-tests. The random allocation sequence will be performed by a researcher not involved in testing or in monitoring the interventions. Two opaque bags will be used: (i) the first bag containing folded papers with the names of the participants; (ii) the second bag containing the intervention (i.e., A or B). In each round, the researcher will remove a paper from the second bag, followed by a paper from the first bag. Allocation will be concealed from all other researchers until the start of the intervention. The two main testers will not be provided with this information, to ensure they remain blinded. If allocation suggests problems with baseline values, creating imbalances in the groups with respect to the values obtained in the four tests, the randomization process will be repeated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two weeks of familiarization with protocols and testing. Then, randomization with cross-over design. Two weeks of intervention, followed by two weeks of wash-out, followed by two weeks of intervention.
| Arm | Type | Receives |
|---|---|---|
| Warm-up based on small-sided games | Experimental | Behavioral: Inter and intra-individual variation in acute responses to two different warm-up typesIntervention A is based on football-specific small-sided games (SSGs), consisting of 4 versus 4 matches (with mini-goals), performed in a 30 m by 24 m court (Giménez et al., 2018), using five sets of 90 seconds of work interspersed with 30 seconds of pause, in a total duration of 10 minutes. |
| Warm-up based on potentiation principles (e.g., speed, change of direction, plyometrics) | Experimental | Behavioral: Inter and intra-individual variation in acute responses to two different warm-up typesIntervention B is based on speed, COD and plyometrics (i.e., a "potentiation" protocol), inspired by ideas presented by Howe, Coward, and Price (2017). Participants will perform five repetitions of the following exercises, in this order: unilateral hurdle hops and lateral hurdle hops with each lower limb; CMJ; broad jump; forward in and out; slalom jumps; lateral scissor jumps; single leg linear hops. Each intervention will last ~10 minutes and will be applied in the football field. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants will be 40 to 50 healthy football players from the U16 and U17 teams of a club from the Oporto city, engaged in three weekly training sessions with an average weekly training volume of 270 minutes.
Key exclusion criteria (1 listed)
- Following similar research (Beato, De Keijzer, et al., 2019), participants will have to be free from injuries or illness at the start of the study.
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 |
|---|---|---|
| Inter and intra-individual variation in acute responses to two different warm-up typesComparison of the acute effects of two different warm-up protocols on subsequent performance. | Behavioural | Warm-up based on potentiation principles (e.g., speed, change of direction, plyometrics), Warm-up based on small-sided games |
Primary outcome
Linear speed
Time frame: Through study completion (8 weeks)
Straight line sprinting (20-m linear sprinting test)
Pre-programmed change-of-direction
Time frame: Through study completion (8 weeks)
Illinois Agility Test (IAT) without ball and with ball (IATB)
Lower limb power
Time frame: Through study completion (8 weeks)
Countermovement jump height
1 secondary outcome
Harms and/or side-effects
Time frame: Through study completion (8 weeks)
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 9 May 2023.
- Individual participant dataSharing planned: No
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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.
José Afonso, Ph.D. principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inter and intra-individual variation in acute responses to two different warm-up types in people with Healthy, run by Universidade do Porto at 1 site in Portugal.
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: withdrawn, as of the sponsor's last update on 9 May 2023. 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 Portugal. 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?
Linear speed (time frame: Through study completion (8 weeks)). The study lists 3 primary outcomes in all. 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 9 May 2023.