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Promotion of physical activity and fitness in sedentary patients with Parkinson's disease: randomised controlled trial [with consumer summary]
van Nimwegen M, Speelman AD, Overeem S, van de Warrenburg BP, Smulders K, Dontje ML, Borm GF, Backx FJG, Bloem BR, Munneke M, on behalf of the ParkFit Study Group
BMJ 2013 Mar 1;346:f576
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. DESIGN: Multicentre randomised controlled trial. SETTING: 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). PARTICIPANTS: 586 sedentary patients with idiopathic Parkinson's disease aged between 40 and 75 years with mild to moderate disease severity (Hoehn and Yahr stage <= 3). INTERVENTION: Patients were randomly assigned to the ParkFit programme or a matched general physiotherapy intervention. ParkFit is a multifaceted behavioural change programme, designed specifically to achieve an enduring increase in the level of physical activity (coaches using motivational strategies; ambulatory feedback). MAIN OUTCOME MEASURES: The primary endpoint was the level of physical activity, measured every six months with a standardised seven day recall (LASA physical activity questionnaire-LAPAQ). Secondary endpoints included two other measures of physical activity (activity diary and ambulatory activity monitor), quality of life (Parkinson's disease questionnaire-PDQ-39), and fitness (six minute walk test). RESULTS: 540 (92.2%) patients completed the primary outcome. During follow-up, overall time spent on physical activities (LAPAQ) was comparable between the groups (adjusted group difference 7%, 95% confidence interval -3 to 17%; p = 0.19). Analyses of three secondary outcomes indicated increased physical activity in ParkFit patients, as suggested by the activity diary (difference 30%; p < 0.001), the activity monitor (difference 12%; p < 0.001), and the six minute walk test (difference 4.8 m; p = 0.05). PDQ-39 did not differ between ParkFit patients and controls (difference -0.9 points; p = 0.14). The number of fallers was comparable between ParkFit patients (184/299; 62%) and controls (191/287; 67%). CONCLUSIONS: The ParkFit behavioural change programme did not increase overall physical activity, as measured with the LAPAQ. The analysis of the secondary endpoints justifies further work into the possible merits of behavioural change programmes to increase physical activities in daily life in Parkinson's disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT00748488.
Reproduced with permission from the BMJ Publishing Group.

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