Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer

<p>Abstract</p> <p>Background</p> <p>The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologic mechanisms, patient-reported outcomes, and biomarkers in women with operable breast cancer following the completion of definitive adjuvant therapy.</p> <p>Methods/Design</p> <p>Using a single-center, randomized design, 174 postmenopausal women (58 patients/study arm) with histologically confirmed, operable breast cancer presenting to Duke University Medical Center (DUMC) will be enrolled in this trial following completion of primary therapy (including surgery, radiation therapy, and chemotherapy). After baseline assessments, eligible participants will be randomized to one of two supervised aerobic training interventions (moderate-intensity or moderate/high-intensity aerobic training) or an attention-control group (progressive stretching). The aerobic training interventions will include 150 mins.wk^-1of supervised treadmill walking per week at an intensity of 60%-70% (moderate-intensity) or 60% to 100% (moderate to high-intensity) of the individually determined peak oxygen consumption (VO_2peak) between 20-45 minutes/session for 16 weeks. The progressive stretching program will be consistent with the exercise interventions in terms of program length (16 weeks), social interaction (participants will receive one-on-one instruction), and duration (20-45 mins/session). The primary study endpoint is VO_2peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO_2peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks).</p> <p>Discussion</p> <p>EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO_2peakand other pertinent outcomes in women who have completed definitive adjuvant therapy for operable breast cancer. Overall, this trial will inform and refine exercise guidelines to optimize recovery in breast and other cancer survivors following the completion of primary cytotoxic therapy.</p> <p>Trial Registration</p> <p>NCT01186367</p

The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design

<p>Abstract</p> <p>Background</p> <p>The Lung Cancer Exercise Training Study (LUNGEVITY) is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO_2peak), patient-reported outcomes, and the organ components that govern VO_2peakin post-operative non-small cell lung cancer (NSCLC) patients.</p> <p>Methods/Design</p> <p>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 VO_2peakfor 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 VO_2peak. 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.</p> <p>Discussion</p> <p>VO_2peakis 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.</p> <p>Trial Registration</p> <p>NCT00018255</p

Effect of exercise on cardiac autonomic function in females with rheumatoid arthritis

The objective of this study is to evaluate the effect of exercise on cardiac autonomic function as measured by short-term heart rate variability (HRV) in females suffering from rheumatoid arthritis (RA). Females with confirmed RA were randomly assigned to an exercise group (RAE) and a sedentary group (RAC). RAE was required to train under supervision two to three times per week, for 3 months. Three techniques (time domain, frequency domain and Poincaré plot analyses) were used to measure HRV at baseline and study completion. At baseline, RAC (n018) had a significantly higher variability compared to RAE (n019) for most HRV indicators. At study completion, the variables showing significant changes (p00.01 to 0.05) favoured RAE in all instances. Wilcoxon signed rank tests were performed to assess changes within groups from start to end. RAE showed significant improvement for most of the standing variables, including measurements of combined autonomic influence, e.g. SDRR (p00.002) and variables indicating only vagal influence, e.g. pNN50 (p00.014). RAC mostly deteriorated with emphasis on variables measuring vagal influence (RMSSD, pNN50, SD1 and HF (ms2)). Study results indicated that 12 weeks of exercise intervention had a positive effect on cardiac autonomic function as measured by short-term HRV, in females with RA. Several of the standing variables indicated improved vagal influence on the heart rate. Exercise can thus potentially be used as an instrument to improve cardiac health in a patient group known for increased cardiac morbidity.http://www.springerlink.com/content/102818

Efeitos de exercícios aquáticos sobre a aptidão cardiorrespiratória e a pressão arterial em hipertensas Effects of aquatic exercise on cardiorespiratory fitness and blood pressure in hypertensive women

O estudo visou avaliar a influência de um programa de exercícios aquáticos sobre a aptidão cardiorrespiratória e a pressão arterial em mulheres hipertensas. Dez hipertensas participaram do programa de exercícios aquáticos - aeróbicos, de fortalecimento, alongamento e relaxamento - duas vezes por semana durante 7 semanas, totalizando 14 sessões. Foram avaliadas pelo teste de esforço cardiorrespiratório antes e após o desenvolvimento do programa. A pressão arterial foi mensurada ao repouso e aos 10, 20 e 30 minutos após o exercício em cada sessão. As variáveis cardiorrespiratórias não apresentaram alterações significativas após o programa, tanto dos valores de limiar de anaerobiose quanto os do pico de esforço. As pressões arteriais sistólica, diastólica e média de repouso permaneceram estáveis no decorrer do programa. Entretanto, no período pós-exercício, os níveis da pressão arterial sistólica (PAS) e média (PAM) foram significativamente menores, quando comparados aos valores pré-exercício: houve redução média de 6,43 mmHg da PAS e 3,08 mmHg da PAM aos 30 minutos pós-exercício. Assim, o programa de exercícios aquáticos proposto não promove ganho aeróbico efetivo, mas os resultados sugerem que exercícios aquáticos como os propostos, em intensidade próxima ao limiar de anaerobiose, desencadeiam redução dos níveis de pressão arterial no período pós-exercício, em mulheres hipertensas.<br>The aim of this study was to assess the influence of an aquatic exercise program on cardiorespiratory fitness and blood pressure in hypertensive women. Ten hypertensive women took part in the study. The program consisted of aquatic aerobic, strengthening, and stretching exercises in intensity near the anaerobic threshold, besides relaxation, twice a week during 7 weeks, totalling 14 sessions. They were assessed by cardiorespiratory exercise testing before and after program development. Blood pressure was measured at rest before and at 10, 20, and 30 minutes after exercise, at the end of each session. After the hydrotherapy program, cardiorespiratory ranges did not show significant changes, neither at the anaerobic threshold nor at the effort peak. Systolic (SBP), diastolic (DBP), and mean (MBP) blood pressure at rest remained stable all through the program. However, SBP and MBP levels at 30-minute rest after exercises, at the end of the program, were significantly lower when compared to pre-exercise ones: there was a mean 6,43 mmHg SBP decrease and a 3,08 mmHg MBP decrease. The hydrotherapy program thus did not promote effective aerobic increase, but results suggest that the proposed exercises, performed at near-anaerobic threshold, may reduce post-exercise SBP and MBP levels in hypertensive women