Dataset Information

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.

ABSTRACT:

Background

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.

Methods/design

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?¹ of 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?peak) 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?peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO?peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks).

Discussion

EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO?peak and 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.

Trial registration

NCT01186367.

SUBMITTER: Jones LW

PROVIDER: S-EPMC2965727 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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Publications

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.

Jones Lee W LW Douglas Pamela S PS Eves Neil D ND Marcom P Kelly PK Kraus William E WE Herndon James E JE Inman Brant A BA Allen Jason D JD Peppercorn Jeffrey J

BMC cancer 20101006

<h4>Background</h4>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.<h4>Methods/design</h4>Using a single-center, randomized design, 174 postmenopausal wome ...[more]

PMID: 20925920

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Project description:BackgroundModerate-intensity continuous training (MICT) is strongly recommended for polycystic ovarian syndrome (PCOS) treatment. However, recent studies have suggested that high-intensity interval training (HIIT) would promote great benefits for cardiac autonomic control. Therefore, we investigated whether the benefits of HIIT related to cardiovascular autonomic control were greater than those of MICT in women with PCOS.MethodsWomen with PCOS were randomly allocated through a blind draw into three groups: control, MICT, and HIIT. The control group did not undergo exercise, whereas those in the MICT and HIIT groups underwent 16 weeks of aerobic physical training. All groups were evaluated before and after the 16 weeks of intervention in the following aspects: quantification of serum lipids, testosterone, fasting insulin and blood glucose; physical fitness through cardiopulmonary testing; analysis of heart rate variability (HRV) by linear (time domain and frequency domain) and non-linear (symbolic analysis) methods, analysis of blood pressure variability (BPV) and spontaneous baroreflex sensitivity (BRS).ResultsThe final analysis, each group comprised 25 individuals. All groups had similar baseline parameters. After 16 weeks, intragroup comparison showed that the MICT and HIIT groups had a reduction in baseline heart rate (P < 0.001; P < 0.001, respectively) and testosterone levels P < 0.037; P < 0.012, respectively) associated with an increase in VO2peak (MICT, P < 0.001; HIIT, P < 0.001). The MICT (P < 0.36) and HIIT (P < 0.17) groups also showed an increase in cardiac vagal modulation, however only observed in the non-linear analysis. The intergroup comparison showed no differences between the MICT and HIIT groups in any of the hormonal, metabolic and autonomic parameters evaluated, including testosterone, peak oxygen uptake (VO2peak), HRV, BPV and BRS.ConclusionHIIT and MICT showed similar results for the different parameters evaluated. This suggests that both training protocols can be recommended for the treatment of PCOS. Brazilian Clinical Trials Registry (RBR-78qtwy).

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Dataset Information

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.

Background

Methods/design

Discussion

Trial registration

Publications

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.

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