Design and baseline characteristics of the ParkFit study, a randomized controlled trial evaluating the effectiveness of a multifaceted behavioral program to increase physical activity in Parkinson patients

Abstract

Background: Many patients with Parkinson's disease (PD) lead a sedentary lifestyle. Promotion of physical activities may beneficially affect the clinical presentation of PD, and perhaps even modify the course of PD. However, because of physical and cognitive impairments, patients with PD require specific support to increase their level of physical activity.

Methods: We developed the ParkFit Program: a PD-specific and multifaceted behavioral program to promote physical activity. The emphasis is on creating a behavioral change, using a combination of accepted behavioral motivation techniques. In addition, we designed a multicentre randomized clinical trial to investigate whether this ParkFit Program increases physical activity levels over two years in sedentary PD patients. We intended to include 700 sedentary patients. Primary endpoint is the time spent on physical activities per week, which will be measured every six months using an interview-based 7-day recall.

Results: In total 3453 PD patients were invited to participate. Ultimately, 586 patients--with a mean (SD) age of 64.1 (7.6) years and disease duration of 5.3 (4.5) years--entered the study. Study participants were younger, had a shorter disease duration and were less sedentary compared with eligible PD patients not willing to participate.

Discussion: The ParkFit trial is expected to yield important new evidence about behavioral interventions to promote physical activity in sedentary patients with PD. The results of the trial are expected in 2012.

Trial registration: http://clinicaltrials.gov (nr NCT00748488).

Figure 1

Design of the ParkFit study.

Figure 2

Flow chart of the inclusion procedure. * No Parkinson's disease = patient is diagnosed with parkinsonism or patient declared to have no gratifying and sustained response to dopaminergic therapy; ** No sedentary lifestyle = > 3 times a week vigorous-intensity physical activity > 60 minutes; or > 3 times a week moderate-intensity physical activity > 150 minutes; *** Severe disease = H&Y > III; MMSE < 24; severe co-morbidity interfering with daily functioning; use of daily care in an institution; or deep brain stimulation.