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“Exercise and Parkinson”: The Park-in-Shape study


- candidate number19301
- NTR NumberNTR4743
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-aug-2014
- Secondary IDsNL 47747.091.14 
- Public Title“Exercise and Parkinson”: The Park-in-Shape study
- Scientific TitleThe Park-in-Shape study: a randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson’s disease.
- ACRONYM
- hypothesisWe hypothesize that intensive aerobic exercise in sedentary PD patients results in clinically relevant improvements of several disease-related symptoms.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Physical activity
- Inclusion criteria1) Idiopathic Parkinson’s disease, according to the UK Brain Bank criteria, diagnosed by a neurologist
2) H&Y stage ≤2
3) Age 30-75 years
4) Sedentary lifestyle (insufficient aerobic physical activity, as defined by the current American College of Sports Medicine (ACSM) recommendations for older adults23).
5) Both medicated and unmedicated patients are eligible, if they:
 Receive a stable dopaminergic medication dose (both levo-dopa and/or a dopamine agonist are allowed) for one month before the study
 Are umedicated and deemed unlikely to start treatment within the next month by their treating neurologist
- Exclusion criteria1) Use of beta-blockers
2) Use of anti-psychotics
3) Inability to cycle or perform stretching exercises due to (other) neurologic or orthopedic co-morbidities
4) Inability to fill out questionnaires or perform a computer task (i.e due to poor vision, inability to read Dutch (illiteracy or foreign language)
5) Psychiatric diseases, including major depressive disorder, severe or moderate depressive episode or any form of psychosis, diagnosed by a psychiatrist in the last year.
6) No internet at home
7) MMSE <24
8) Contra-indications for aerobic exercise including diagnosed cardiac diseases (for instance but not exclusive: unstable angina, heart block, arrhythmia’s, uncontrolled hypertension), diagnosed but poorly controlled diabetes mellitus or pulmonary diseases (e.g. but not exclusive COPD, exertional asthma, pulmonary emphysema).
9) Unavailable for more than 10% (approximately 2.5 weeks) of the 6 months
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2014
- planned closingdate1-okt-2017
- Target number of participants130
- InterventionsAerobic exercise, exergaming; 3-5x/wk for 6 months
- Primary outcomeUPDRS-motor score after six months
- Secondary outcomeOther motor and non-motor symptoms, quality of life, physical fitness after 6 months
- TimepointsAssessments at baseline and after 6 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD N.M. Kolk, van der
- CONTACT for SCIENTIFIC QUERIESProf. Dr. B.R. Bloem
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Private fund
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-aug-2014 - 21-jan-2015


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