Limits...
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 LW, Douglas PS, Eves ND, Marcom PK, Kraus WE, Herndon JE, Inman BA, Allen JD, Peppercorn J - BMC Cancer (2010)

Bottom Line: 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 VO₂peak, as measured by an incremental cardiopulmonary exercise test.All endpoints will be assessed at baseline and after the intervention (16 weeks).

View Article: PubMed Central - HTML - PubMed

Affiliation: Duke University Medical Center, Durham, NC, USA. lee.w.jones@duke.edu

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 (VO₂peak) 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 VO₂peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO₂peak, 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 VO₂peak 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.

Show MeSH

Related in: MedlinePlus

Study Flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC2965727&req=5

Figure 1: Study Flow.

Mentions: The study flow is presented in Figure 1. Using a three-arm, randomized design, potential subjects will be identified and screened for eligibility by the study research coordinators via medical record review of patients scheduled to attend a 'follow-up' consultation at the Duke Breast Cancer Survivorship Clinic as per standard of care or following direct referral from their oncologist. Following primary attending oncologist approval, potential eligible subjects will be provided with a thorough review of the study and asked if they are willing to participate. After obtaining written consent, all participants will complete the following assessments in order of presentation: (1) fasting blood draw and oral glucose tolerance test, (2) peripheral vascular endothelial function, (3) spirometry and cardiopulmonary exercise test, and (4) echocardiogram at rest and during exercise and (5) PRO survey forms. On the following day, patients will undergo a tissue biopsy of the vastus lateralis. Participants will be asked to adhere to a water-only fast for 8 hours prior to testing on both days. All baseline assessments will be repeated at the end of the intervention (16 weeks). To maximize internal validity, study personnel, time of the day, equipment, and assessment order and timing will be the same at baseline and postintervention.


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 LW, Douglas PS, Eves ND, Marcom PK, Kraus WE, Herndon JE, Inman BA, Allen JD, Peppercorn J - BMC Cancer (2010)

Study Flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2965727&req=5

Figure 1: Study Flow.
Mentions: The study flow is presented in Figure 1. Using a three-arm, randomized design, potential subjects will be identified and screened for eligibility by the study research coordinators via medical record review of patients scheduled to attend a 'follow-up' consultation at the Duke Breast Cancer Survivorship Clinic as per standard of care or following direct referral from their oncologist. Following primary attending oncologist approval, potential eligible subjects will be provided with a thorough review of the study and asked if they are willing to participate. After obtaining written consent, all participants will complete the following assessments in order of presentation: (1) fasting blood draw and oral glucose tolerance test, (2) peripheral vascular endothelial function, (3) spirometry and cardiopulmonary exercise test, and (4) echocardiogram at rest and during exercise and (5) PRO survey forms. On the following day, patients will undergo a tissue biopsy of the vastus lateralis. Participants will be asked to adhere to a water-only fast for 8 hours prior to testing on both days. All baseline assessments will be repeated at the end of the intervention (16 weeks). To maximize internal validity, study personnel, time of the day, equipment, and assessment order and timing will be the same at baseline and postintervention.

Bottom Line: 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 VO₂peak, as measured by an incremental cardiopulmonary exercise test.All endpoints will be assessed at baseline and after the intervention (16 weeks).

View Article: PubMed Central - HTML - PubMed

Affiliation: Duke University Medical Center, Durham, NC, USA. lee.w.jones@duke.edu

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 (VO₂peak) 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 VO₂peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO₂peak, 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 VO₂peak 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.

Show MeSH
Related in: MedlinePlus