van der Kolk 2015.
Trial name or title | Park‐in‐Shape study: a phase II double blind randomised controlled trial evaluating the effects of exercise on motor and non‐motor symptoms in Parkinson’s disease |
Methods | RCT |
Participants | 130 people with Parkinson’s disease Inclusion criteria: clinical diagnosis of PD, H&Y I to II, 30 to 75 years old, sedentary lifestyle, stable medication, MMSE ≥ 24 Exclusion criteria: history of other neurological, psychiatric, mellitus, pulmonary, or orthopaedic diseases, no Internet at home, unavailability |
Interventions | Experimental group (EG: n = 65); control group (CG: n = 65) 3 times per week/6 months EG: 30 to 45 min aerobic exercise equipped with gaming elements CG: 30 to 45 min non‐aerobic intervention including stretching, flexibility, and relaxation exercises |
Outcomes | Outcomes recorded at baseline and postintervention Primary outcome: MDS‐UPDRS motor score (Off) Secondary outcomes: MDS‐UPDRS (On), Mini‐Balance Evaluation Systems Test, Timed Up and Go Test, Dexterity device of Objective Parkinson's Disease Measurement system, falls and near‐falls, Montreal Cognitive Assessment scale, Test of Attentional Performance, Trail Making Test A and B, Hamilton Anxiety and Depression Scale, Scales for Outcomes in Parkinson’s Disease–Sleep and Gastrointestinal, Fatigue Severity Scale, PDQ‐39, Six‐Minute Walk Test, therapy adherence |
Starting date | ‐ |
Contact information | Bas R Bloem: bas.bloem@radboudumc.nl |
Notes | Registered on trialregister.nl (NTR4743) Protocol paper van der Kolk 2015 |