Professional Documents
Culture Documents
com
IP Online First, published on December 13, 2013 as 10.1136/injuryprev-2013-041092
Study protocol
vanCopyright
der Horst N, et Article
al. Inj Prev author
2013;0:1–5.(or their employer) 2013.
doi:10.1136/injuryprev-2013-041092 Produced by BMJ Publishing Group Ltd under licence. 1
Downloaded from injuryprevention.bmj.com on August 25, 2014 - Published by group.bmj.com
Study protocol
Figure 1 Consolidate standards of reporting trials (CONSORT) flow diagram of trial design.
intervention group by an online research randomizer (http:// the ground as slowly as possible to maximise loading in the
www.randomizer.org). eccentric phase. Hands and arms are used to break his
forward fall and to push him back up after the chest has
Study setting touched the ground to minimise loading in the concentric
This trial is being carried out in collaboration with the Royal phase.32 The exercise was supervised by the team coach or
Netherlands Football Association (KNVB). Soccer teams from medical staff and took place immediately after the completion
four separate districts playing in Dutch first-class (‘Eerste of normal training as recommended by Small et al,33 before
Klasse’) amateur field soccer competition were invited to partici- cooling down.
pate. These teams generally play one or two matches a week, After the winter break in the 2012–2013 season (last 2 weeks
with two or three training sessions per week. After the four dis- in December), all teams started their normal training schedule
tricts had been selected, instruction meetings, to inform the about 3–5 weeks before the competition restarted (the season
purpose and methods of the study, were held for the coaches typically runs from July to May), which is typical for elite
and medical staff of participating teams, organised by the amateur soccer competition in Western Europe. The interven-
research team in each district. tion (see table 1) started at the beginning of this training sched-
ule, with a constructive phase (weeks 1–5) and a maintenance
Eligibility criteria phase (weeks 6–13).24 25
Dutch male amateur soccer players, aged 18–40 years, were eli- Players in the intervention group were instructed to perform
gible for inclusion. Players who joined a participating team after 25 sessions of the Nordic hamstring exercise during the first
the start of the trial were not included. All players were asked to 13 weeks after the winter break. Players were told about the
give their informed consent before the start of this study. Players possibility of Delayed Onset of Muscle Soreness (DOMS), a
unwilling to do so were excluded from the trial. known side effect of eccentric exercises.32 Players who were
injured at the beginning of the intervention could start the
protocol week 1 after full recovery. Players who sustained an
Intervention
injury during the intervention period, which limited the execu-
The ‘Nordic hamstring exercise’, in literature also referred to as
tion of the Nordic hamstring exercise, were instructed to
the Nordic curl, improves the eccentric strength of the hamstring
contact the research team.
muscles. The exercise is performed in pairs (see figure 2).24
Players start in a kneeling position, with the torso from the
knees upward held rigid and straight. The training partner
ensures that the player’s feet are in contact with the ground Table 1 Nordic hamstring exercise protocol
throughout the exercise by applying pressure to the player’s
Week Frequency Number of sets Repetitions per set
heels/lower legs. The player then lowers his upper body to
1 1 p/week 2 p/training 5
2 2 p/week 2 p/training 6
3 2 p/week 3 p/training 6
4 2 p/week 3 p/training 6, 7, 8
5 2 p/week 3 p/training 8, 9, 10
6-13 2 p/week 3 p/training 10, 9, 8
Data collection
Baseline characteristics
Prior to the start of the intervention, all players completed a
questionnaire to record baseline characteristics: date of birth,
weight, height, nationality, years of experience as a soccer
player, leg dominance, field position, preventive measures taken
(such as inlays, taping, bandages, thermal pants, muscle
strengthening exercises or stretching) and other injuries incurred
Figure 2 The Nordic hamstring exercise (adapted from Petersen et al before the start of the study (in particular, hamstring injuries
[24]). and anterior cruciate ligament injuries).
Study protocol
Hamstring injuries (in minutes) of training sessions (both group and individual
The medical staff of participating teams (eg, physical therapists training) followed and the number and duration (in minutes) of
and/or sports masseurs) are responsible for registering all ham- matches played are recorded weekly for 1 year by the team
string injuries for a full calendar year (2013). A hamstring injury coach, using a computer-based registration form. Match expos-
is defined as any physical complaint affecting the posterior side ure is defined as play between teams from different clubs.10
of the upper leg irrespective of the need for medical attention or Training exposure is defined as team-based and individual phys-
time loss from soccer activities.10 A recurrent hamstring injury is ical activities under the control or guidance of the team’s coach-
defined as an injury of the same type and at the same site as an ing or fitness staff that are aimed at maintaining or improving
index injury and which occurs after a player’s return to full par- players’ soccer skills or physical condition.10 Coaches will also
ticipation from the index injury.10 Recurrent injuries are subdi- record reasons why players do not attend training or matches
vided into ‘early recurrences’ within 2 months after a player’s (eg, sickness, injury, hamstring injury, individual training, train-
return to full participation, ‘late recurrences’ between 2 and ing elsewhere or other) per individual player.
12 months after a player’s return to full participation and The research team will remain in contact weekly (by tele-
‘delayed recurrences’ more than 12 months after a player’s return phone, email or visits) with team coaches and players having a
to full participation.10 All hamstring injuries are registered on a view to encouraging compliance with data registration. In add-
special form, and a so-called recovery form is completed when ition, newsletters, evaluation meetings and a website designed
the player is fully recovered. Data are being collected on the epi- for this specific study will be used to stimulate participation and
demiology (location, type and duration of the injury) and aeti- compliance.
ology (including intrinsic and extrinsic factors, such as injury The intervention teams will be monitored with regard to
history and field condition) of the hamstring injury and informa- implementation and performance of the Nordic hamstring exer-
tion on residual complaints and tertiary prevention. cise and other self-initiated preventive strategies for hamstring
injuries (eg, core stability and plyometric exercises) and the
Hamstring-and-lower-back flexibility control teams will be monitored with regard to self-initiated
Hamstring-and-lower-back flexibility (HLBF) was measured in preventive measures for hamstring injuries, specifically the
all players at the start of the study, using the Sit-and-Reach test Nordic hamstring exercise.
(SRT)34–37 (see figure 3).
The medical staff was instructed how to perform the SRT Outcomes
procedure at the soccer club. Participants were not allowed to Primary outcomes are the incidence of initial and recurrent
warm up before doing the SRT. A player is asked to sit on the hamstring injuries, the severity of the injury and the number of
floor, with the legs together, the knees extended, the ankles in intervention sessions completed. Secondary outcomes are HLBF
90° dorsiflexion and the soles of the bare feet placed against the and compliance. Data will be collected from all participants.
foot panel of the test box. Then, the player is asked to place his The incidence of injuries is reported as the number of injuries
hands on top of each other with the hand palms facing down- per 1000 player-hours for both matches and training.10 Injury
ward, and to slowly reach forward as far as possible, moving a severity is defined as the number of days that have elapsed from
reach indicator along the measuring scale on the box and to the date of injury to the date of the player’s return to full par-
hold the maximum stretch for 2 s. The test supervisor ensures ticipation in team training and availability for match selection.10
that the player’s knees, arms and fingers remain extended
throughout the test. Both knees should be locked during the Sample size
test. Measurements are repeated twice, with a 15 s interval, On the basis of the literature, we expected that the intervention
during which the player is allowed to sit up straight, but not to would lead to a 70% reduction in the rate of hamstring injury
stand up or stretch. SRT scores were recorded to the nearest compared with control.24 During a soccer season, about one in
0.5 cm. HLBF was not measured in players who were unable to 11 players has a hamstring injury with a 30% chance of recurrent
perform the SRT as instructed (eg, because of limited knee hamstring injury.24 With two-sided testing, a significance level of
extension after injury). 0.05 and power of 0.8, each study group should include 175
players. With a clustered design, an inflation factor (intracluster
correlation coefficient=0.05) of 1.9 was applied to the sample
size, and with an estimated dropout rate of 7%8 24 we calculated
that 712 players would need to be recruited (n=356 for interven-
tion group and n=356 for control group). Since first-class
amateur teams consist of about 19 players, a total of 38 teams
was considered sufficient.
STATISTICAL METHODS
SPSS V.21.0 will be used to analyse the quantitative data.
Descriptive statistics (means and SD) will be used to describe
baseline characteristics and exposure data. The incidence of
initial and recurrent hamstring injuries will be analysed on an
Figure 3 Sit-and-Reach test. intention-to-treat basis.
T tests and Mann–Whitney U tests will be used for continu-
ous variables and χ2 tests for categorical variables. Poisson
Exposure and compliance general log-linear analysis and Cox hazards regression with sur-
The number of times a player performed the Nordic hamstring vival curves will be used to compare the intervention and
exercise protocol (intervention group), the number and duration control groups.
Study protocol
Compliance with the intervention will be calculated on the basis Patient consent Obtained.
of information provided by the team coaches. As the protocol con- Ethics approval The medical ethics committee of the University Medical Center
sists of 25 sessions, compliance will be calculated per team as: nh Utrecht (File number 12-575/C).
(amount of Nordic hamstring exercise sessions)/25 × 100=% Provenance and peer review Not commissioned; internally peer reviewed.
compliance. Additional analysis will be performed to check Data sharing statement If required, we are willing to share data, including
whether certain variables are related to missing data or dropout. relevant analyses, to any reviewers.
Study protocol
29 Junge A, Lamprecht M, Stamm H, et al. Country-wide campaign to prevent soccer 34 Wells KF, Dillon EK. The sit-and-reach. A test of back and leg flexibility. Research
injuries in Swiss amateur players. Am J Sports Med 2011;39:57–63. Quarterly 1952;23:115–18.
30 Moher D, Hopewell S, Schulz KF, et al. Consort 2010 explanation and elaboration: 35 Ayala F, Sainz de Baranda P, De Ste Croix M, et al. Criterion-related validity of four
updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol clinical tests used to measure hamstring flexibility in professional futsal players. Phys
2010;63:e1–37. Ther Sport 2011;12:175–81.
31 Torgerson DJ. Contamination in trials: is cluster randomisation the answer? BMJ 36 Ayala F, Sainz de Baranda P, De Ste Croix M, et al. Absolute reliability of five
2001;322:355–7. clinical tests for assessing hamstring flexibility in professional futsal players. J Sci
32 Mjølsnes R, Arnason A, Østhagen T, et al. A 10-week randomized trial comparing Med Sport 2012;15:142–7.
eccentric vs. concentric hamstring strength training in well-trained soccer players. 37 Ayala F, Sainz de Baranda P, De Ste Croix M, et al. Reproducibility and criterion-related
Scand J Sci Sports 2004;14:311–17. validity of the sit and reach test and toe touch test for estimating hamstring flexibility in
33 Small K, McNaughton L, Greig M, et al. Effect of timing of eccentric hamstring recreationally active young adults. Phys Ther Sport 2012;13:219–26.
strengthening exercises during soccer training: implications for muscle fatigability. 38 Krleza-Jeric K, Lemmens T. 7th revision of the Declaration of Helsinki: good news
J Strength Cond Res 2009;23:1077–83. for the transparency of clinical trials. Croat Med J 2009;50:105–10.
These include:
References This article cites 37 articles, 14 of which can be accessed free at:
http://injuryprevention.bmj.com/content/early/2013/12/13/injuryprev-2013-041092.full.html#ref-lis
t-1
P<P Published online December 13, 2013 in advance of the print journal.
Email alerting Receive free email alerts when new articles cite this article. Sign up in
service the box at the top right corner of the online article.
Notes
Advance online articles have been peer reviewed, accepted for publication, edited and
typeset, but have not not yet appeared in the paper journal. Advance online articles are
citable and establish publication priority; they are indexed by PubMed from initial
publication. Citations to Advance online articles must include the digital object identifier
(DOIs) and date of initial publication.