Effects of Aerobic Exercise Versus Weight Training in Breast Cancer Survivors During Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Research Alliance
Information provided by:
University of Alberta, Physical Education
ClinicalTrials.gov Identifier:
NCT00115713
First received: June 23, 2005
Last updated: March 22, 2007
Last verified: March 2007
  Purpose

The purpose of this study is to compare the effects of two different types of exercise, aerobic exercise training (AET) and resistance exercise training (RET), on quality of life (QoL) in early stage breast cancer survivors receiving chemotherapy. It is hypothesized that both AET and RET would have beneficial effects on QoL.


Condition Intervention Phase
Breast Neoplasms
Behavioral: Aerobic Exercise Training
Behavioral: Resistance Exercise Training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of Aerobic Versus Resistance Exercise Training in Enhancing Quality of Life in Early Stage Breast Cancer Survivors Receiving Chemotherapy: A Multi-Centre Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Alberta, Physical Education:

Primary Outcome Measures:
  • Quality of Life

Secondary Outcome Measures:
  • Physical Fitness
  • Body Composition
  • Lymphedema
  • Treatment Completion Rates
  • Selected Biomarkers
  • Exercise Adherence Rates and Determinants

Estimated Enrollment: 240
Study Start Date: April 2003
Study Completion Date: December 2005
Detailed Description:

The study was a prospective, three-armed, randomized controlled trial. Participants were stratified by site (Edmonton, Ottawa, and Vancouver) and planned chemotherapy protocol (taxane-based versus nontaxane-based) and randomly assigned to AET, RET, or usual care (UC) in a 1:1:1 ratio using a random-numbers table. Participants assigned to the AET group were asked to perform aerobic exercise three times per week on a recumbent or upright cycle ergometer, treadmill, or elliptical. Exercise duration began at 15 minutes for weeks 0 through 2, and then systematically increased by 5 minutes every three weeks thereafter to 45 minutes for weeks 18 and beyond. Exercise intensity began at 60% of VO2max for weeks 0 through 2 and then systematically increased by 10% every 6 weeks thereafter to 80% of VO2max for weeks 12 and beyond. Warm-up and cool-down periods consisted of 5 minutes of aerobic activity at the power output of the ventilatory equivalent for oxygen (approximately 50% of peak oxygen consumption). Participants assigned to the RET group were asked to perform resistance exercise three times per week, which consisted of two sets of 10 repetitions of 9 different exercises performed at 60-70% of 1-repetition maximum. The specific exercises were: leg extension, leg curl, calf raises, chest press, latissimus pulldown, overhead press, triceps extension, biceps curls, and modified curl-ups. Resistance was increased by approximately 10% or the next weight level when the participant was able to complete 12 repetitions per set without difficulty.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer early stage I –IIIA
  • Completed axillary surgery
  • Scheduled to receive adjuvant chemotherapy for 9 – 24 weeks
  • Approval of the treating oncologist
  • Able to understand and provide written informed consent in English or French (Ottawa)
  • 18+ years of age
  • No uncontrolled hypertension, cardiac illness, psychiatric condition
  • No contraindication to exercise as determined by a fitness test

Exclusion Criteria:

  • Pregnant.
  • Unwilling to accept randomization.
  • Any medical condition that would be a contraindication to exercise. The clinicians will make this decision.
  • Unwilling to travel to/participate in the exercise program as defined by the protocol.
  • Previous chemotherapy (previous cancer is NOT an exclusion criteria).
  • Cancer recurrence.
  • Planned/known absence of greater than 2 weeks during the intended study period.
  • Previous therapy for known breast cancer.
  • Those who have had TRAM (i.e., Transabdominal Rectus Abdominus Muscle Reconstructive Surgery) done.
  • Moderate lymphedema (>20% or >200mL difference between the affected arm and the unaffected arm).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115713

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G2H9
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T123
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada
Sponsors and Collaborators
University of Alberta, Physical Education
Canadian Breast Cancer Research Alliance
Investigators
Principal Investigator: Kerry S Courneya, PhD University of Alberta
  More Information

No publications provided by University of Alberta, Physical Education

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00115713     History of Changes
Other Study ID Numbers: ETH-02-70-85
Study First Received: June 23, 2005
Last Updated: March 22, 2007
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta, Physical Education:
Aerobic Exercise
Weight Lifting
Breast Cancer
Quality of Life

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

ClinicalTrials.gov processed this record on September 22, 2014