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Randomized Controlled Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors. The CARE Trial.

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Randomized Controlled Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors. The CARE Trial.

BACKGROUND: Aerobic exercise has been shown to improve physical fitness and quality of life
(QoL) in breast cancer survivors receiving chemotherapy but no study to date has examined
the addition of resistance exercise to aerobic exercise in this population. Resistance
exercise has proven to be an important adjunct to aerobic exercise in the cardiac
rehabilitation population although few trials have controlled for the total volume of

PURPOSE: The primary purpose of the present trial is to compare the effects of a combined
aerobic and resistance exercise program (COMB) to a standard moderate volume of aerobic
exercise (STAN) and a higher volume of aerobic exercise (HIGH) that controls for the total
volume of exercise in the COMB arm.

METHODS: The study will be a prospective, three-armed, randomized controlled trial conducted
in Edmonton (coordinating center), Ottawa, and Vancouver. Participants will be 300 breast
cancer survivors scheduled to receive adjuvant chemotherapy. All three exercise groups will
be asked to perform supervised exercise 3 days/week for the length of their chemotherapy
treatment. The STAN group will be asked to perform approximately 500 kilocalories/week of
self-selected aerobic activities (e.g., treadmill, cycle ergometer, elliptical). This arm of
the trial is considered standard care based on the emerging consensus of recent systematic
reviews and recommendations from major cancer agencies. The HIGH group will be asked to
complete approximately 1,000 kilocalories/week of self-selected aerobic activities. The COMB
group will be asked to complete 1,000 kilocalories/week split equally between aerobic and
resistance exercise. The primary endpoint in the trial will be change in physical
functioning between baseline and post intervention as assessed by the physical functioning
subscale of the Short Form (SF) 36 scale. Secondary endpoints will include cardiorespiratory
fitness (maximal treadmill test), muscular strength (8 repetition maximum tests), muscular
endurance (standard load test at 50% of estimated baseline maximum), body composition (DEXA
scans), psychological distress, sleep quality, exercise adherence, and chemotherapy
completion rates.

RELEVANCE: An important issue for breast cancer survivors receiving chemotherapy is whether
there is any advantage to increasing the volume of aerobic exercise or adding resistance
exercise to a standard aerobic exercise program. If there is an advantage, then it is
important that breast cancer survivors receive this optimal exercise prescription to
maximize their ability to cope with their chemotherapy treatments and maintain their
physical function and QoL during this difficult time.

Inclusion Criteria

- Are diagnosed with stage I-IIIA breast cancer, histologically confirmed

- Are scheduled to receive adjuvant chemotherapy (receiving neoadjuvant chemotherapy
for locally advanced cancer is an exclusion criteria)

- Have not received previous chemotherapy (previous cancer is NOT an exclusion

- Have not received transabdominal rectus abdominis muscle (TRAM) reconstructive

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Outcome Measure:

Patient rated physical functioning

Outcome Time Frame:

at 8 weeks and 24 weeks

Safety Issue:


Principal Investigator

Kerry Courneya, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:

BR-01-0080 ethics 22148



Start Date:

January 2008

Completion Date:

January 2014

Related Keywords:

  • Breast Cancer
  • aerobic exercise
  • resistance exercise
  • physical fitness
  • body composition
  • quality of life
  • rehabilitation
  • psychosocial oncology
  • adherence
  • Breast Neoplasms