NCT00249015

Brief Summary

Endurance exercise such as walking has been shown to help breast cancer survivors maintain their energy and quality of life while they are receiving chemotherapy, but there have not been any studies on weight training. In this study, the researchers want to determine if a combined program of endurance and weight training exercises is better than a standard amount of endurance exercise or even a higher amount of endurance exercise in breast cancer survivors receiving chemotherapy. The study will be an experimental design in which the researchers have breast cancer survivors participate in one of the three different exercise programs. The researchers' main interest is in patient rated physical functioning and quality of life, which they will measure before and after the exercise programs by asking participants how they feel on various rating scales. The researchers will also measure their aerobic fitness on a treadmill and how strong they are by having them lift weights.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Jan 2008

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 18, 2016

Status Verified

June 1, 2014

Enrollment Period

6.2 years

First QC Date

November 4, 2005

Last Update Submit

July 14, 2016

Conditions

Breast Cancer

Keywords

aerobic exerciseresistance exercisephysical fitnessbody compositionquality of liferehabilitationpsychosocial oncologyadherence

Outcome Measures

Primary Outcomes (1)

  • Patient rated physical functioning

    at 8 weeks and 24 weeks

Secondary Outcomes (1)

  • Physical fitness, body composition, treatment completion rates, exercise adherence rates, adverse events

    at 8 weeks and 24 weeks

Study Arms (3)

1

EXPERIMENTAL

Combined Aerobic and Resistance Exercise Program: perform three exercise sessions per week consisting of about 25-30 minutes of aerobic exercise at a moderate-to-vigorous intensity as well as some weight training consisting of two sets of 8-12 repetitions of 9-10 different exercises. For the aerobic exercise, participant can choose from different exercise equipment such as a treadmill or stationary bicycle.

Behavioral: Physical exercise

2

ACTIVE COMPARATOR

Moderate Aerobic Exercise Group: perform three exercise sessions per week consisting of about 25-30 minutes of aerobic exercise at a moderate-to-vigorous intensity. Again, participant can choose from different exercise equipment.

Behavioral: Physical exercise

3

EXPERIMENTAL

High Aerobic Exercise Group: perform three exercise sessions per week consisting of about 45-60 minutes of aerobic exercise at a moderate-to-vigorous intensity. Again, participant can choose from different exercise equipment.

Behavioral: Physical exercise

Interventions

Physical exerciseBEHAVIORAL

perform exercise program 3 days per week and 5 minutes of warm-up and cool-down exercises before and after the main exercise component

123

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Have not received transabdominal rectus abdominis muscle (TRAM) reconstructive surgery
  • Are 18 years or older
  • Received approval from their treating oncologist
  • No uncontrolled hypertension, cardiac illness or psychiatric condition or any other medical condition that would be a contraindication to exercise
  • Able to understand and provide written informed consent in English or French (Ottawa)
  • Complete maximal aerobic and strength tests. No contraindication to exercise as determined by fitness tests
  • Are not pregnant
  • Willing to accept randomization and complete their assigned exercise program
  • If participant is currently exercising (e.g., swimming at the Y 3 times per week) must be willing to give this up in place of their randomly assigned program
  • Willing to travel to fitness center 3 times/week to complete exercise program
  • Willing to complete all assessments (except blood) at all timepoints including 6, 12, and 24 month follow-ups
  • Must not have a planned/known absence of greater than 2 weeks during the intended intervention period and must be able/willing to perform exercise sessions on their own during any planned absences of less than 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Publications (3)

  • An KY, Arthuso FZ, Kang DW, Morielli AR, Ntoukas SM, Friedenreich CM, McKenzie DC, Gelmon K, Mackey JR, Courneya KS. Exercise and health-related fitness predictors of chemotherapy completion in breast cancer patients: pooled analysis of two multicenter trials. Breast Cancer Res Treat. 2021 Jul;188(2):399-407. doi: 10.1007/s10549-021-06205-8. Epub 2021 Mar 29.

    PMID: 33779887DERIVED

  • An KY, Kang DW, Morielli AR, Friedenreich CM, Reid RD, McKenzie DC, Gelmon K, Mackey JR, Courneya KS. Patterns and predictors of exercise behavior during 24 months of follow-up after a supervised exercise program during breast cancer chemotherapy. Int J Behav Nutr Phys Act. 2020 Feb 14;17(1):23. doi: 10.1186/s12966-020-00924-9.

    PMID: 32059728DERIVED

  • Courneya KS, Segal RJ, Vallerand JR, Forbes CC, Crawford JJ, Dolan LB, Friedenreich CM, Reid RD, Gelmon K, Mackey JR, McKenzie DC. Motivation for Different Types and Doses of Exercise During Breast Cancer Chemotherapy: a Randomized Controlled Trial. Ann Behav Med. 2016 Aug;50(4):554-63. doi: 10.1007/s12160-016-9782-z.

    PMID: 26896305DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kerry Courneya, PhD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2005

First Posted

November 7, 2005

Study Start

January 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 18, 2016

Record last verified: 2014-06

Locations

CA(1)