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Optimal Type of Aerobic Training in Breast Cancer (Excite)

This study is currently recruiting participants.
Verified November 2012 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01186367
First received: August 19, 2010
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to determine the effect of exercise training on women who have completed adjuvant therapy for early stage breast cancer.


Condition Intervention Phase
Breast Cancer
 Behavioral: High-Intensity Aerobic Training
Behavioral: Moderate-Intensity Aerobic Training
Behavioral: Progressive Stretching
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of Optimal Type of Aerobic Training in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • To compare the effect of high-intensity to moderate-intensity aerobic training, relative to attention-control, on peak oxygen consumption. [ Time Frame: 3 time-points ] [ Designated as safety issue: Yes ]
    VO2 or peak oxygen consumption will be measured at 3 time-points. Baseline, mid-point (8 weeks), and post-intervention (16 weeks).


Estimated Enrollment: 174
Study Start Date: August 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-intensity Training
Aerobic training will be prescribed based on the principles of the ACSM guidelines based on the investigator preference and prior published data with the aim of improving VO2 peak. All session will be on a cycle ergometry and last 30-45 minutes in duration. The goal is to perform 100% of baseline peak.
 Behavioral: High-Intensity Aerobic Training
Exercise will take place at the Center for Living in Durham, North Carolina three days per week. All exercise is supervised by a master's trained Exercise Physiologist.
Experimental: Moderate-Intensity Training
The goal for moderate-intensity training is 5 cycle ergometry 3 times per week at 75% pf baseline VO2 for 30-45 minutes per session.
 Behavioral: Moderate-Intensity Aerobic Training
Exercise will take place at the Center for Living in Durham, North Carolina three days per week. All exercise is supervised by a master's trained Exercise Physiologist.
Experimental: Progressive Stretching
The progressive stretching program will be prescribed according to the ACSM guidelines for older adults and aimed at increasing whole-body flexibility.
 Behavioral: Progressive Stretching
Exercise will take place at the Center for Living in Durham, North Carolina three days per week. All exercise is supervised by a master's trained Exercise Physiologist.

Detailed Description:

In this study we want to compare the effect of high-intensity to moderate-intensity aerobic training, relative to attention-control, on peak oxygen consumption.

This study will include women who are at least 21 years old, an interval of no longer than 5 years following completion of primary therapy, life expectancy of greater than 6 months, sedentary, willingness to be randomized, and signed consent form prior to all study assessments.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 21 years old
  • An interval of at least 1 year following completion of primary therapy
  • An interval of no longer than 5 years following completion of primary therapy.
  • Estimated life expectancy > 6 months
  • Ability to read and understand English
  • Primary attending oncologist approval
  • Sedentary
  • Willingness to be randomized
  • Signed informed consent form prior to initiation of study-related procedures

Exclusion Criteria:

  • Presence of a concurrent, actively treated other malignancy or history of other malignancy treated within the past three years.
  • Presence of metastatic disease
  • No contraindication to a maximal exercise test or aerobic training and defined by the American Thoracic Society
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186367

Contacts
Contact: Lee W Jones, PhD 919-668-6791 lee.w.jones@duke.edu
Contact: Miranda West, B.S. 919-681-5494 miranda.west@duke.edu

Locations
United States, North Carolina
Duke Center for Living Recruiting
Durham, North Carolina, United States, 27710
Contact: Miranda West, BS     919-681-5494     miranda.west@duke.edu    
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Lee W Jones, PhD Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01186367     History of Changes
Other Study ID Numbers: Pro00022294
Study First Received: August 19, 2010
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013