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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.

van der Kolk NM, Overeem S, de Vries NM, Kessels RP, Donders R, Brouwer M, Berg D, Post B, Bloem BR - BMC Neurol (2015)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

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.

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/design: 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.

Discussion: 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.

Trial registration: Dutch trial register NTR4743.

No MeSH data available.


Related in: MedlinePlus

Study designPark-in-shape.
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Fig1: Study designPark-in-shape.

Mentions: The Park-in-Shape study is a randomized controlled, double-blinded study performed in a single center (Figure 1). Patients are randomly assigned to the intervention (aerobic exercise) or the active control group (stretching), but are unaware of the allocation possibilities. The assessors performing the baseline and follow-up assessments (directly after the intervention period of 6 months) are also blinded for allocation. Motivational aspects are applied in both groups to increase compliance (see below for further details).Figure 1


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.

van der Kolk NM, Overeem S, de Vries NM, Kessels RP, Donders R, Brouwer M, Berg D, Post B, Bloem BR - BMC Neurol (2015)

Study designPark-in-shape.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4418070&req=5

Fig1: Study designPark-in-shape.
Mentions: The Park-in-Shape study is a randomized controlled, double-blinded study performed in a single center (Figure 1). Patients are randomly assigned to the intervention (aerobic exercise) or the active control group (stretching), but are unaware of the allocation possibilities. The assessors performing the baseline and follow-up assessments (directly after the intervention period of 6 months) are also blinded for allocation. Motivational aspects are applied in both groups to increase compliance (see below for further details).Figure 1

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

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.

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/design: 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.

Discussion: 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.

Trial registration: Dutch trial register NTR4743.

No MeSH data available.


Related in: MedlinePlus