search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effect of preventive exercises on hamstring and calf muscle characteristics


- candidate number29506
- NTR NumberNTR7455
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jul-2018
- Secondary IDsNL63496.018.17  Case number provided by Central Committee on Human Research on the website toetsingonline.nl
- Public TitleEffect of preventive exercises on hamstring and calf muscle characteristics
- Scientific TitleEvaluation of the efficacy of hamstring and calf muscle prevention programs through ultrasound and DT-MRI measures
- ACRONYMBAMI
- hypothesisEvaluate the efficacy of exercise prevention programs on hamstring and calf injuries by assessing muscle characteristics using DT-MRI.
- Healt Condition(s) or Problem(s) studiedHamstring injuries, Calf muscle injuries
- Inclusion criteria- Capable of doing an active exercise program
- Male basketball player (only for hamstring injury prevention study)
- Female basketball player (only for calf injury prevention study)
- Age > 16 years old
- Exclusion criteria- There are contraindications for the MR: claustrophobia, pregnancy, pacemaker etc.
- Hamstring/calf muscle injuries within the past year
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-aug-2018
- planned closingdate
- Target number of participants144
- InterventionsParticipants will be randomized to either i) Nordic exercises (NHE) ii) Diver exercises or iii) no-training specific hamstrings intervention. Duration, sessions per week and sets/repetitions for the hamstring prevention exercises are based on previous reports with a total duration of 3 months. Instruction of the exercises will be given through the caregiver with written and video documentation. These hamstring exercises are well described in the current literature and examples are presented on YouTube (NHE: https://www.youtube.com/watch?v=qPRZcNx_C0A; Diver: https://www.youtube.com/watch?v=3JwxQy2OSus)

For the calf prevention study (CIP) female basketball players will be randomized to i) modified eccentric Alfredson’s heel drop exercises; ii) concentric heel drop exercises or iii) no-training specific calf intervention. Basketball players are instructed to perform each repetition in 2 seconds.2 Duration, sessions per week and sets/repetitions for calf prevention exercises are based on previous reports with a total duration of 3 months. These calf exercises are well described in the current literature and examples are presented on YouTube (Alfredson’s heel drop exercise: https://www.youtube.com/watch?v=ge3XDjjKofk)
- Primary outcomeThe two DT-MRI derived parameters to evaluate muscle characteristics include the pennation angle (PA: the angle of the fascicles relative to the tendon; degrees); fascicle length (FL: the length of the muscle fascicles running between the aponeuroses/tendons; mm) of the Biceps Femoris, Semitendinosus and Semimembranosus or Gastrocnemius and soleus muscle.
- Secondary outcomeClinical examination will be performed at every visit. Findings will be scored accordingly on a standardized form and include pain on palpation, active and passive range of motion. Hamstring and calf strength will be evaluated with dynamometer.19-22
• Hamstring strength
• Calf strength
• Playing hours per participant
• MR outcome parameters to assess muscle characteristics
o cross-sectional area (CSA; mm2)
o muscle thickness (MT; mm)
o muscle volume (MV; mm3)
• Injury rate (injury per 1000 playing hours) with injury type and location
o Severity defined as time-loss injuries. Time-loss is defined as time (in days) absent from either training or matches.
o Patient reported Outcome score: Functional Assessment Scale for Acute Hamstring Injuries.14
• EMG amplitude and activation patterns of the following muscles:
o Hamstrings
o Gastrocnemius
o Quadriceps
o Adductor
o Gluteal and trunk muscles
• Spatiotemporal EMG distribution within the hamstring muscle
• Joint kinematics of the:
o Ankle
o Knee
o Hip
o Trunk
- TimepointsAll outcomes will be measured at two timepoints, namely baseline and 3 months follow-up. The outcomes will be measured as described above in primary and secondary outcomes.
- Trial web sitewww.hamstringonderzoek.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES O. Kilic
- CONTACT for SCIENTIFIC QUERIES J. Tol
- Sponsor/Initiator Amsterdam UMC
- Funding
(Source(s) of Monetary or Material Support)
National Basketball Association (NBA), General Electric Healthcare
- Publications
- Brief summaryThe current literature on prevention of muscle injuries in basketball is limited and there are no clinical outcome studies in elite female basketball. Previous studies among football players have shown that preventive exercises can be successful in the prevention of muscle injuries. These exercises seem to induce changes in muscle characteristics e.g. lengthening of fascicle length (FL) and alteration of pennation angle (PA), which are measured by ultrasound. There are some concerns about the reliability of ultrasound measurements as it is an investigator-dependent procedure and only allows indirect calculation of FL and PA. With diffusion tension magnetic resonance imagining (DT-MRI) it is possible to directly assess these muscle characteristics with a high reliability. For this reason two randomized controlled trials will be performed among dutch male and female basketball players. The basketball players will be asked to perform a preventive exercise for 3 months (or no exercise for the control group) whereafter alterations within their hamstring (male) and calf (female) muscle architecture will be assessed through DT-MRI measures. Volunteers will be recruited in the Netherlands.
- Main changes (audit trail)
- RECORD9-sep-2018 - 9-sep-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl