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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p><url>http://clinicaltrials.gov</url> (nr NCT00748488).</p

Low Physical Activity and Cardiorespiratory Fitness in People With Schizophrenia: A Comparison With Matched Healthy Controls and Associations With Mental and Physical Health

Introduction: The aim of this study was to objectively assess time spent in physical activity (PA) and sedentary behavior (SB) in patients with schizophrenia compared to healthy controls matched for age, gender and socioeconomic status. Associations between both PA and cardiorespiratory fitness (CRF) and mental and physical health parameters in patients with schizophrenia were examined. Materials and Methods: Moderate and vigorous PA (MVPA), moderate PA, vigorous PA, total and active energy expenditure (TEE and AEE), number of steps, lying down and sleeping time was assessed with SenseWear Pro-2 body monitoring system for three 24-h bouts in patients with schizophrenia (n = 63) and matched healthy controls (n = 55). Severity of symptoms (Positive and Negative Syndrome Scale and Montgomery and Åsberg Depression Rating Scale), CRF (peak oxygen uptake, VO2peak), body mass index (BMI), and metabolic syndrome were assessed. Results: Patients with schizophrenia performed less MVPA and moderate activity had lower TEE and AEE, spent more time per day lying down and sleeping, and had poorer CRF compared to healthy controls. The amount of MVPA, but especially CRF was associated with severity of negative symptoms in patients with schizophrenia. Only CRF was associated with BMI. Discussion: The current data offer further evidence for interventions aiming to increase physical activity and decrease sedentary behavior. Given strong associations of CRF with both negative symptoms and BMI, treatment aimed at CRF-improvement may prove to be effective.status: publishe

The associations of cardiorespiratory fitness, adiposity and sports participation with arterial stiffness in youth with chronic diseases or physical disabilities

Background The evidence on the associations of cardiorespiratory fitness, body adiposity and sports participation with arterial stiffness in children and adolescents with chronic diseases or physical disabilities is limited. Methods Altogether 140 children and adolescents with chronic diseases or physical disabilities participated in this cross-sectional study. Cardiorespiratory fitness was assessed using maximal exercise test with respiratory gas analyses either using shuttle run, shuttle ride, or cycle ergometer test. Cardiorespiratory fitness was defined as peak oxygen uptake by body weight or fat-free mass. Body adiposity was assessed using waist circumference, body mass index standard deviation score and body fat percentage. Sports participation was assessed by a questionnaire. Aortic pulse wave velocity and augmentation index were assessed by a non-invasive oscillometric tonometry device. Results Peak oxygen uptake/body weight (standardised regression coefficient β −0.222, 95% confidence interval (CI) −0.386 to −0.059, P = 0.002) and peak oxygen uptake/fat-free mass (β −0.173, 95% CI −0.329 to −0.017, P = 0.030) were inversely and waist circumference directly (β 0.245, 95% CI 0.093 to 0.414, P = 0.002) associated with aortic pulse wave velocity. However, the associations of the measures of cardiorespiratory fitness with aortic pulse wave velocity were attenuated after further adjustment for waist circumference. A higher waist circumference (β −0.215, 95% CI −0.381 to −0.049, P = 0.012) and a higher body mass index standard deviation score (β 0.218, 95% CI −0.382 to −0.054, P = 0.010) were related to lower augmentation index. Conclusions Poor cardiorespiratory fitness and higher waist circumference were associated with increased arterial stiffness in children and adolescents with chronic diseases and physical disabilities. The association between cardiorespiratory fitness and arterial stiffness was partly explained by waist circumference.peerReviewe

Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study) : study protocol for a randomized controlled trial

BACKGROUND: Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design. METHODS/DESIGN: The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function. DISCUSSION: The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection. TRIAL REGISTRATION: NCT01893008

Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial

BACKGROUND: Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design. METHODS/DESIGN: The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function. DISCUSSION: The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection. TRIAL REGISTRATION: NCT01893008.status: publishe