The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design.
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2010-04-21
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BACKGROUND: The Lung Cancer Exercise Training Study (LUNGEVITY) is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO2peak), patient-reported outcomes, and the organ components that govern VO2peak in post-operative non-small cell lung cancer (NSCLC) patients. METHODS/DESIGN: Using a single-center, randomized design, 160 subjects (40 patients/study arm) with histologically confirmed stage I-IIIA NSCLC following curative-intent complete surgical resection at Duke University Medical Center (DUMC) will be potentially eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of four conditions: (1) aerobic training alone, (2) resistance training alone, (3) the combination of aerobic and resistance training, or (4) attention-control (progressive stretching). The ultimate goal for all exercise training groups will be 3 supervised exercise sessions per week an intensity above 70% of the individually determined VO2peak for aerobic training and an intensity between 60 and 80% of one-repetition maximum for resistance training, for 30-45 minutes/session. Progressive stretching will be matched to the exercise groups in terms of program length (i.e., 16 weeks), social interaction (participants will receive one-on-one instruction), and duration (30-45 mins/session). The primary study endpoint is VO2peak. Secondary endpoints include: patient-reported outcomes (PROs) (e.g., quality of life, fatigue, depression, etc.) and organ components of the oxygen cascade (i.e., pulmonary function, cardiac function, skeletal muscle function). All endpoints will be assessed at baseline and postintervention (16 weeks). Substudies will include genetic studies regarding individual responses to an exercise stimulus, theoretical determinants of exercise adherence, examination of the psychological mediators of the exercise - PRO relationship, and exercise-induced changes in gene expression. DISCUSSION: VO2peak is becoming increasingly recognized as an outcome of major importance in NSCLC. LUNGEVITY will identify the optimal form of exercise training for NSCLC survivors as well as provide insight into the physiological mechanisms underlying this effect. Overall, this study will contribute to the establishment of clinical exercise therapy rehabilitation guidelines for patients across the entire NSCLC continuum. TRIAL REGISTRATION: NCT00018255.
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Jones, Lee W, Neil D Eves, William E Kraus, Anil Potti, Jeffrey Crawford, James A Blumenthal, Bercedis L Peterson, Pamela S Douglas, et al. (2010). The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. BMC Cancer, 10. p. 155. 10.1186/1471-2407-10-155 Retrieved from https://hdl.handle.net/10161/4354.
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Scholars@Duke
![Kraus](https://scholars.duke.edu/profile-images/thumbnail200/0078469.jpg)
William Erle Kraus
My training, expertise and research interests range from human integrative physiology and genetics to animal exercise models to cell culture models of skeletal muscle adaptation to mechanical stretch. I am trained clinically as an internist and preventive cardiologist, with particular expertise in preventive cardiology and cardiac rehabilitation. My research training spans molecular biology and cell culture, molecular genetics, and integrative human exercise physiology and metabolism. I practice as a preventive cardiologist with a focus on cardiometabolic risk and exercise physiology for older athletes. My research space has both a basic wet laboratory component and a human integrative physiology one.
One focus of our work is an integrative physiologic examination of exercise effects in human subjects in clinical studies of exercise training in normal individuals, in individuals at risk of disease (such as pre-diabetes and metabolic syndrome; STRRIDE), and in individuals with disease (such as coronary heart disease, congestive heart failure and cancer).
A second focus of my research group is exploration of genetic determinates of disease risk in human subjects. We conduct studies of early onset cardiovascular disease (GENECARD; CATHGEN), congestive heart failure (HF-ACTION), peripheral arterial disease (AMNESTI), and metabolic syndrome. We are exploring analytic models of predicting disease risk using established and innovative statistical methodology.
A third focus of my group’s work is to understand the cellular signaling mechanisms underlying the normal adaptive responses of skeletal muscle to physiologic stimuli, such as occur in exercise conditioning, and to understand the abnormal maladaptive responses that occur in response to pathophysiologic stimuli, such as occur in congestive heart failure, aging and prolonged exposure to microgravity.
Recently we have begun to investigate interactions of genes and lifestyle interventions on cardiometabolic outcomes. We have experience with clinical lifestyle intervention studies, particularly the contributions of genetic variants to interventions responses. We call this Lifestyle Medicopharmacogenetics.
KEY WORDS:
exercise, skeletal muscle, energy metabolism, cell signaling, gene expression, cell stretch, heart failure, aging, spaceflight, human genetics, early onset cardiovascular disease, lifestyle medicine
![Crawford](https://scholars.duke.edu/profile-images/thumbnail200/0112878.jpg)
Jeffrey Crawford
- Lung cancer/new treatment approaches.
2. Clinical trials of hematopoietic growth factors, biological agents and targeted drug development.
3. Cancer in the elderly and supportive care
Accomplishments
1. Lead Investigator of the U. S. multicenter, randomized trial of Filgrastim (G-CSF, Neupogen) to reduce the morbidity of chemotherapy-related neutropenia, leading to FDA approval 2/91.
2. Lead Investigator of the U. S. multicenter, randomized trial of Vinorelbine (Navelbine) in treatment of patients with advanced non small cell carcinoma of lung (NSCLC), leading to FDA approval 12/94.
3. Principal Investigator in initial phase I clinical trials of stem cell factor (SCF), megakaryocyte growth and development factor (MGDF), pegylated granulocyte-colony-stimulating factor and other novel hematopoietic growth factors.
![Blumenthal](https://scholars.duke.edu/profile-images/thumbnail200/0097908.jpg)
James Alan Blumenthal
Psychosocial factors and coronary heart disease, including such factors as social support, Type A behavior and hostility, and depression, exercise training and depression in the elderly; behavioral approaches to the treatment of hypertension (e.g., weight loss and exercise); cardiac rehabilitation; neuropsychological outcomes following cardiac surgery; psychosocial aspects of heart and lung transplantation; exercise training and osteoarthritis and fibromyalgia; compliance.
![Douglas](https://scholars.duke.edu/profile-images/thumbnail200/0330178.jpg)
Pamela Susan Douglas
Pamela S Douglas MD is the Ursula Geller Professor of Research in Cardiovascular Diseases in the Department of Medicine at Duke University and Director of the Multimodality Imaging Program at Duke Clinical Research Institute. During her 30+ years of experience she has led several landmark multicenter government studies and pivotal industry clinical trials along with outcomes research studies. She is renowned for her scientific and policy work in improving the quality and appropriateness of imaging in clinical care, clinical trials and registries and through development and dissemination of national standards for imaging utilization, informatics and analysis. She has been among the pioneers in a number of areas including heart disease in women, sports cardiology, and cardio-oncology. Dr. Douglas’ wealth of experience includes authorship of over 400 peer reviewed manuscripts and 30 practice guidelines, and service as the President of the American College of Cardiology, President of the American Society of Echocardiography, and Chief of Cardiology at both the University of Wisconsin and Duke University. She has also previously served on the faculties of the University of Pennsylvania and Harvard University. She currently serves on the External Advisory Council of the National Heart, Lung and Blood Institute and the Scientific Advisory Board of the Patient Advocate Foundation.
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