|- candidate number||13208|
|- NTR Number||NTR3561|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-aug-2012|
|- Secondary IDs||2012/56 NL Presto TWOR|
|- Public Title||Prevention study on physical complaints in conservatory students.|
|- Scientific Title||A multicentre, single blinded, randomized controlled trial on the (cost) effectiveness of a prevention course on reducing or preventing disabilities from musculoskeletal complaints in music students at Dutch conservatories.|
|- hypothesis||Is a prevention program, based on principles of health behavior change, education about playing-related musculoskeletal disorders and postural training, more effective in preventing and/ or reducing disabilities from musculoskeletal complaints in conservatory students when compared with a physical activity program based on health behavior change using pedometer monitoring?|
|- Healt Condition(s) or Problem(s) studied||Work-related disorders of upper limbs, Playing-related musculoskeletal disorders, Exercise therapy, Mensendieck|
|- Inclusion criteria||First year bachelor music students:|
1. Major classical music;
2. Major historical music;
3. Major music education.
|- Exclusion criteria||1. Singers;|
2. Jazz/pop/musical students;
3. Students with a specific comorbidity as: Rheumatoid Arthritis, Ankylosing Spondylitis, Multiple Sclerosis;
4. Non Dutch or English speakers.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2012|
|- planned closingdate||30-jun-2016|
|- Target number of participants||152|
|- Interventions||1. Presto-Play;|
“Presto-Play” is a prevention course based on theoretical models of behavior change, which comprises education about music playing-related health problems, evidence-based prevention strategies and postural training.
“Presto-Fit” is a physical activity program, directed at behavior change regarding physical activity behavior. In the latter program activity monitoring (by pedometry) is used to increase physical activity. Total duration of both programs is 18 hours in 8 months; lessons will start at beginning of year 1.
|- Primary outcome||Disability (DASH).|
|- Secondary outcome||1. Pain (McGill);|
2. Quality of Life (SF-36).
|- Timepoints||T0: Baseline (start school year 1 conservatory study);|
T1: Week 10;
T2: Week 20;
T3: Post treatment (end school year 1);
T4: Follow-up: 16 months (start school year 3);
T5: Follow-up: 24 months (end school year 3).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Vera Baadjou|
|- CONTACT for SCIENTIFIC QUERIES|| Vera Baadjou|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI, The Research Institute of the University Maastricht and University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|Limburg University Fund/ SWOL|
|- Publications||Baadjou VA, van Eijsden-Besseling MD, Samama-Polak AL, Smeets RJ, Passos VL, Westerterp KR. Energy expenditure in brass and woodwind instrumentalists: the effect of body posture. Med Probl Perform Art. 2011 Dec;26(4):218-23.|
|- Brief summary||Rationale: |
Up to 87% of professional classical musicians develop work-related complaints of the musculoskeletal system during their career. Previous research has identified several risk factors associated with music playing related complaints in physical, psychological and behavioral domains. Conservatory students are at specific risk for developing musculoskeletal complaints and disabilities. Prevention programs seem to be a promising development, although research on specific programs is insufficient.
The first study objective is to evaluate the effectiveness of a specific prevention course on reducing and preventing disabilities from playing-related musculoskeletal disorders in Dutch conservatory students compared with a physical activity program. The second objective is to evaluate the cost-effectiveness of the abovementioned interventions.
Multicentre, single-blinded, randomized controlled trial.
Healthy, first year conservatory students will be recruited for participation.
“Presto-Play” is a prevention course based on theoretical models of behavior change, which comprises education about music playing-related health problems, evidence-based prevention strategies and postural training. “Presto-Fit” is a physical activity program, directed at behavior change regarding physical activity behavior. In the latter program activity monitoring (by pedometry) is used to increase physical activity. Total duration of both programs is 18 hours in 8 months; lessons will start at beginning of year 1.
Main study parameters/endpoints:
Main study parameter is disability. A mediator and moderator analysis will be performed. Supposed mediators are self-efficacy, depression/anxiety/stress, coping, pain catastrophizing and perfectionism. Supposed moderators are expectancy & credibility, experiences with musculoskeletal complaints, hypermobility, and physical activity. Secondary endpoints are pain and quality of life. Parameters to measure behaviour change are based on awareness of musculoskeletal complaints in musicians, motivation for change, and effect factors such as disability. A fidelity check is integrated in the process evaluation.
|- Main changes (audit trail)|
|- RECORD||7-aug-2012 - 16-aug-2012|