title: Design of the Park-in-Shape study: a phase II double blind randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson's disease.
abstract: BACKGROUND
  Parkinson's disease (PD) is a neurodegenerative disorder with a wide range of motor and non-motor symptoms. Despite optimal medical management, PD still results in a high disability rate and secondary complications and many patients lead a sedentary lifestyle, which in turn is also associated with a higher co-morbidity and mortality. Exercise has been explored as a strategy to reduce secondary complications and results suggests that it not only provides general health benefits, but may also provide symptomatic relief. If this holds true exercise would be a very attractive addition to the therapeutic arsenal in PD. The supportive evidence remains incomplete. Here, we describe the design of the Park-in-Shape study, which primarily aims to evaluate whether aerobic exercise affords clinically relevant improvements in motor symptoms in sedentary PD patients. A specific new element is the introduction of gaming to optimize compliance to the exercise intervention.
  
  
  METHODS
  The Park-in-Shape study is a randomized controlled, assessor- and patient-blinded single center study. Two parallel groups will include a total of 130 patients, receiving either aerobic exercise on a home trainer equipped with gaming elements ("exergaming"), or a non-aerobic intervention (stretching, flexibility and relaxation exercises). Both groups are supported by a specifically designed motivational app that uses gaming elements to stimulate patients to exercise and rewards them after having completed the exercise. Both interventions are delivered at home at least 3 times a week for 30-45 minutes during 6 months. Eligible patients are community-dwelling, sedentary patients diagnosed with mild-moderate PD. The primary outcome is the MDS-UPDRS motor score (tested in the off state) after 6 months. Secondary outcomes include various motor and non-motor symptoms, quality of life, physical fitness, and adherence.
  
  
  CONCLUSIONS
  This Park-in-Shape study is anticipated to answer the question whether high intensity aerobic exercise combined with gaming elements ("exergaming") provides symptomatic relief in PD. Strong elements include the double-blinded randomized controlled trial design, the MDS-UPDRS as valid primary outcome, the large sample size and unique combination of home-based pure aerobic exercise combined with gaming elements and motivational aspects.
  
  
  BACKGROUND
  Dutch trial register NTR4743.
authors.affiliation: Department of Neurology, Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center Nijmegen, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Nicolien.vanderKolk@radboudumc.nl.
authors.forename: Nicolien M
authors.initials: NM
authors.lastname: van der Kolk
authors.affiliation: Department of Neurology, Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center Nijmegen, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Sebastiaan.Overeem@radboudumc.nl.
authors.forename: Sebastiaan
authors.initials: S
authors.lastname: Overeem
authors.affiliation: Department of Neurology, Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center Nijmegen, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Nienke.deVries-Farrouh@radboudumc.nl.
authors.forename: Nienke M
authors.initials: NM
authors.lastname: de Vries
authors.affiliation: Department of Medical Psychology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, the Netherlands. Roy.Kessels@radboudumc.nl.
authors.forename: Roy P C
authors.initials: RP
authors.lastname: Kessels
authors.affiliation: Department of Health Evidence, Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands. Rogier.Donders@radboudumc.nl.
authors.forename: Rogier
authors.initials: R
authors.lastname: Donders
authors.affiliation: Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Marc.Brouwer@radboudumc.nl.
authors.forename: Marc
authors.initials: M
authors.lastname: Brouwer
authors.affiliation: Department of Neurodegeneration, Center for Neurology and Hertie-Institute for Clinical Brain Research, Tübingen, Germany. Daniele.Berg@uni-tuebingen.de.
authors.forename: Daniela
authors.initials: D
authors.lastname: Berg
authors.affiliation: Department of Neurology, Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center Nijmegen, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Bart.Post@radboudumc.nl.
authors.forename: Bart
authors.initials: B
authors.lastname: Post
authors.affiliation: Department of Neurology, Donders Institute for Brain, Cognition, and Behavior, Radboud University Medical Center Nijmegen, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Bas.Bloem@radboudumc.nl.
authors.forename: Bas R
authors.initials: BR
authors.lastname: Bloem
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009048:Motor Skills; D010300:Parkinson Disease / Q000534:rehabilitation*; D010349:Patient Compliance; D010809:Physical Fitness; D011788:Quality of Life; D012107:Research Design; D012944:Social Support; D016896:Treatment Outcome