|- candidate number||6096|
|- NTR Number||NTR1906|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jul-2009|
|- Secondary IDs||METc 2007.217 / 75020009 METc UMC Groningen / ZonMw|
|- Public Title||The GRONORUN 2 study: is a preconditioning program for novice runners effective in preventing running related injuries? A randomized controlled trial.|
|- Scientific Title||The GRONORUN 2 study: is a preconditioning program for novice runners effective in preventing running related injuries? A randomized controlled trial.|
|- ACRONYM||GRONORUN 2|
|- hypothesis||A preconditioning program with a gradual increase of biomechanical load, prior to the start of a training program, will result in a reduction in running related injuries in novice runners compared to the control group.|
|- Healt Condition(s) or Problem(s) studied||Prevention, Running related injuries|
|- Inclusion criteria||Healthy novice runners between 18 and 65 years of age.|
|- Exclusion criteria||1. Running experience in the last 12 months prior to the start of the study;|
2. No injury of the lower limb or lower back in the past 3 months prior to start of the study;
3. Absolute contraindications for vigourous physicla activities according to the American College of Sports Medicine (ACSM).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2008|
|- planned closingdate||11-okt-2009|
|- Target number of participants||414|
|- Interventions||A 4 week preconditioning program prior to the start of a traditional running training program. The preconditioning program includes walking three times a week and hopping exercises during two walking sessions. |
|- Primary outcome||The incidence of running related injuries.|
|- Secondary outcome||1. The severity of running related injuries;|
2. The compliance of the training program;
3. The compliance of running in the consecutive year.
|- Timepoints||1. Inclusion July 2008;|
2. Endpoint: Four mile run 2009 ('4 Mijl van Groningen 11-10-2009').
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD S.W. Bredeweg|
|- CONTACT for SCIENTIFIC QUERIES||MD S.W. Bredeweg|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), University Center for Sport, Exercise and Health|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Running is a popular form of recreational exercise. Although running has positive effects on health and fitness, the risk of a running related injury (RRI) has to be considered. The incidence of RRI’s is high and varies from 30-79%. In novice runners an RRI can negatively affect future physical activity, so the prevention of running injuries especially in novice runners is important.
High quality studies on the prevention of RRI’s are scarce. When conducting a randomized controlled trial (RCT) it is important that the intervention can be implemented in the real world, has a good compliance and will be adopted by runners and coaches.|
Therefore in this two-arms RCT we propose a preconditioning program of 4 weeks prior to a 10 week training program in a group of novice runners compared to a 10 week training program without preconditioning. We hypothesize that the novice runner can adapt more gradually to the high mechanical loads of running and therefore will be less susceptible for sustaining a RRI. The concept of preconditioning is already proven in other preventive sports injuries research.
In the long follow-up period, valuable information will be gathered for a better understanding of modifiable risk factors in running-related overuse injuries.
|- Main changes (audit trail)|
|- RECORD||14-jul-2009 - 10-okt-2009|