Contemporary clinical trials
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Contemp Clin Trials · Jan 2013
Randomized Controlled Trial Comparative StudyDose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods.
Although progress has been made to elucidate the effects of exercise as a strategy for reducing obesity and related cardiometabolic risk factors, the specific exercise exposures required to achieve optimal benefit continue to be the source of considerable uncertainty and debate. Despite the inference of a dose-dependent relationship between exercise and health benefit, absent from the literature are randomized trials that, without alteration in caloric intake, examine the separate effects of exercise dose and intensity on obesity and associated cardiometabolic risk. We will perform a randomized, controlled trial designed to study the separate effects of habitual exercise differing in dose (energy expenditure, kcal/session) and intensity (relative to VO(2)peak) on abdominal obesity and selected cardiometabolic risk factors. ⋯ Duration of all treatments will be 6 months. The findings from this study may help resolve the following unanswered questions, "For a given exercise dose does higher exercise intensity result in greater health benefits?" "For a given exercise intensity does higher exercise dose result in greater health benefits?". Identification of the separate effects of exercise dose and intensity on obesity and related cardiometabolic risk factors under controlled conditions is important for development of optimal, lifestyle-based strategies that can subsequently be tested in long-term effectiveness trials.
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Contemp Clin Trials · Jan 2013
Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: the model used by the American College of Radiology arm of the National Lung Screening Trial.
In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. ⋯ We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information.
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Contemp Clin Trials · Jan 2013
Randomized Controlled TrialProgressive resistance versus relaxation training for breast cancer patients during adjuvant chemotherapy: design and rationale of a randomized controlled trial (BEATE study).
Cancer-related fatigue is a common severe symptom in breast cancer patients, especially during chemotherapy. Exercise appears to be promising in prevention or treatment of fatigue. Resistance training as an accompanying treatment to chemotherapy has been minimally investigated, yet might counteract muscle degradation and inflammation caused by many chemotherapeutics, and thus forestall or reduce fatigue. Previous exercise trials mostly compared the intervention with 'usual care'. Therefore, it is unclear to what extent the observed effects on fatigue are based on physical adaptations by exercise itself, or rather on psycho-social factors linked to the group support or attention by the trainer. ⋯ Strengths of the BEATE study include the investigation of progressive resistance training parallel with chemotherapy, the choice of a control group that enables an evaluation of the physiological effects of exercise beyond potential psycho-social effects, and the comprehensive and high-quality assessment of physiological factors and biomarkers potentially related to fatigue.
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Contemp Clin Trials · Nov 2012
Randomized Controlled Trial Multicenter StudyEthical considerations and rationale of the MAKI trial: a multicenter double-blind randomized placebo-controlled trial into the preventive effect of palivizumab on recurrent wheezing associated with respiratory syncytial virus infection in children with a gestational age of 33-35 weeks.
Respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) is the most frequent cause of bronchiolitis during infancy. Long-term airway morbidity with recurrent post bronchiolitis wheezing (PBW) episodes, which are probably associated with respiratory infections, occurs in 30 to 70% of infants that were hospitalised with RSV LRTI. ⋯ The Institutional review board (IRB) concluded the study has high clinical relevance because the benefit of 50% chance of protection by palivizumab outweighs the risk of side adverse events due to intramuscular administration of placebo.
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Contemp Clin Trials · Nov 2012
Randomized Controlled Trial Multicenter StudyThe MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features.
This paper presents the rationale and design features of the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research; Clinical Trials.gov NCT00597012). MeTeOR is an NIH-funded seven-center prospective randomized controlled trial (RCT) designed to establish the efficacy of arthroscopic partial meniscectomy combined with a standardized physical therapy program as compared with a standardized physical therapy program alone in patients with a symptomatic meniscal tear in the setting of mild to moderate knee osteoarthritic change (OA). The design and execution of a trial that compares surgery with a nonoperative treatment strategy presents distinctive challenges. The goal of this paper is to provide the clinical rationale for MeTeOR and to highlight salient design features, with particular attention to those that present clinical and methodologic challenges.