Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04508192 |
Other study ID # |
CAvsSQ |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 3, 2020 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
January 2024 |
Source |
Aspetar |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study aims to compare the effects of two different adduction exercises on adduction
strength. Young male football players will be individually randomized to perform one of these
exercises in addition to their normal training. The two exercise protocols are of 8 weeks
duration and are matched in terms of total load.
Description:
Methods Participants Male football players 16 years or older, who are participating in full
team training in Greece, will be included in the study. The study will be conducted
pre-season. During that time each player will have at least 4 training sessions and 1 match
per week.
Exclusion criteria were
- any systematic resistance training of the hip adductors (> 1/week) in the preceding 1
month before study initiation.
- groin pain resulting in loss of one or more football matches/training sessions in the
preceding 1 month prior to study initiation.
- any longstanding injury (≥ 6 weeks) in the lower extremities or in the hip/groin in the
preceding 6 months prior to study initiation.
- pain of more than 2/10 on a numeric rating scale (NRS) when performing the adduction
strength tests or exercises were also excluded.
- For analysis, players will be excluded if there was an adherence of less than 75% of the
exercise sessions.
Ethics Ethical approval was obtained from University of West Attica ethics committee and all
players will give their informed consent prior to inclusion in accordance with the
Declaration of Helsinki.
Randomisation Randomisation will be performed after baseline strength testing. Participants
will be individually randomized to perform either the CA or the SQ exercise protocol. The
randomisation sequence will be obtained using an online software (e.g. randomizer.org), and
sealed, opaque envelopes containing group allocation will be prepared by an independent
person not otherwise involved in the study, and who will be unaware of the baseline strength
test results. All participants will be instructed not to perform any additional adductor
exercise other than their allocated exercise and to keep their regular training as usual.
Blinding The person performing the strength tests will be blinded to group allocation, and
participants will be instructed not to reveal any information about their group allocation.
In addition, the physiotherapist supervising the intervention procedures will not be allowed
to know the results of the strength measurements of each player.
Training intervention Both groups will perform an 8-week training protocol with either the CA
or the SQ exercise performed before or after the normal football training sessions.
Copenhagen Adduction exercise The CA is a high-intensity partner exercise where the player is
lying on their side using the elbow of the lower forearm to support their body and the other
arm placed along their body. The upper arm is supported by the partner who places their one
hand under the knee and the other under the ankle, holding the leg approximately in the
height of their hip. The player performs a 3-second concentric movement lifting their body
until it reaches a straight line. At the same time, the other leg is adducted so that it
touches the other leg. A 3-second eccentric adduction then follows with the body lowered
halfway to the ground and the foot of the lower leg touching the ground without supporting
the body. To ensure a correct performance the therapist instructs the players that there
should not be any side flexion of the trunk or hip during the exercise. Each player performs
one set on each side and then the players change roles. Each couple will be comprised of
players of similar height and weight to ensure optimal conditions.
Adductor Squeeze exercise The SQ exercise is an isometric hip adduction exercise with the
player holding a ball between their knees. The player lies supine with the ball placed
between the knees with the knees and hips flexed and the feet flat on the surface with the
first toe is pointed straight forward. Then the player is asked to press against the ball as
hard as they can. The contraction is held for 10 seconds.
Load progression The CA will be performed with increasing number of repetitions during the
intervention period as the only load progression variable. The number of sets will be kept at
2 sets per side throughout the study. Additionally, the total time under tension (TUT) of the
CA protocol is adjusted to that of the SQ exercise. The SQ exercise has previously been
suggested to be performed in two positions with 5 repetitions of 10 seconds each. This study
will use only one exercise position for comparison, the SQ exercise will be performed for 10
repetitions.
Outcome measures The primary outcome measure of the study will be maximal eccentric adduction
strength (EHAD). Secondary outcome measures will be maximal unilateral isometric adduction
strength (IHAD), and DOMS. The distance between anterior superior iliac spine (ASIS) and the
point of the handheld dynamometer placement will be measured to calculate torque (Nm/kg).
Both the side-lying eccentric adduction and unilateral supine isometric strength measurements
will be conducted on the dominant as well as non-dominant limb. Testing will be conducted in
the club's training facility. The tester will use a handheld dynamometer following
standardized procedures which have been shown to have a good intra-tester reliability:
eccentric adduction strength ICC 0.91 (0.70-0.98), SEM: 6.3% and isometric adduction strength
ICC 0.78 (0.30-0.95), SEM: 7.3%
Compliance Compliance and perceived loading will be recorded after every training session
with the respective intervention exercise, while hip adductor DOMS will be recorded in
respect of the previous training session. Perceived loading will be defined via the Borg CR10
scale and DOMS via a numerical ranking scale (NRS 0-10). All players will be instructed to
avoid any type of training 24h before baseline and follow-up testing. Moreover, the follow-up
testing will be conducted 3 days after the intervention to avoid DOMS potentially influencing
the measures.
Statistical analyses Baseline and follow-up values as well as anthropometric data will be
presented as mean SD, unless otherwise stated. A mixed analysis of variance (ANOVA) will be
used to assess the interactions between groups (CA vs SQ) and time (baseline vs follow-up) on
the dependent variables (EHAD, IHAD and DOMS). Additionally, the simple main effect of time
will be analyzed using a dependent t-test. Cohen's d will be used for effect size (ES)
calculation and will be set as small (0.2), moderate (0.5) and large (0.8) . Statistical
significance level will be set at p 0.05. The data analysis will be performed using SPSS
Statistics (v 26, IBM Corporation).
Sample size A sample size calculation was performed prior to study initiation using G*power
software (v. 3.1, Heinrich-Heine-Universität, Düsseldorf, Germany). Based on previous studies
the expected mean normalized eccentric adduction strength was set at 3.0 Nm/kg with a
standard deviation (SD) of 0.6 Nm/kg. The minimal relevant difference in EHAD strength
between groups was chosen to be 20%, and correlation was arbitrarily set at 0.5. With 80%
power and a type-1 error risk of 5%, and a correlation a total sample size of 42 participants
was adequate to detect a large moderate effect size. To account for dropouts during the
intervention a minimum of 60 participants are included.