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

March 22, 2007 updated by: University of Alberta, Physical Education

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2H9
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T123
        • University of British Columbia
    • Ontario
      • Ottawa, Ontario, Canada
        • Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of Life

Secondary Outcome Measures

Outcome Measure
Body Composition
Physical Fitness
Lymphedema
Treatment Completion Rates
Selected Biomarkers
Exercise Adherence Rates and Determinants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta, Physical Education

Collaborators

Canadian Breast Cancer Research Alliance

Investigators

  • Principal Investigator: Kerry S Courneya, PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

June 23, 2005

First Submitted That Met QC Criteria

June 23, 2005

First Posted (Estimate)

June 24, 2005

Study Record Updates

Last Update Posted (Estimate)

March 23, 2007

Last Update Submitted That Met QC Criteria

March 22, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETH-02-70-85

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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