Travier, N., Velthuis, M.J., Steins Bisschop, C.N., van den Buijs, B., Monninkhof, E.M., Backx, F., . . . May, A.M. (2015). Effects of an 18-week exercise programme started early during breast cancer treatment: A randomised controlled trial. BMC Medicine, 13, 121. 

DOI Link

Study Purpose

To examine the effects of an 18-week exercise program on preventing an increase in fatigue. The intervention is offered early after diagnosis and incorporated into the daily clinical practice setting.

Intervention Characteristics/Basic Study Process

An 18-week exercise program (two 60 minute aerobic and strength exercise session per week and including cognitive behavioral principles) supervised by a physical therapist. The control arm of usual care maintained their usual physical activity pattern for 18 weeks and then could participate in an exercise program.

Sample Characteristics

  • N = 164  
  • MEAN AGE: 49.7 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer diagnosis less than six weeks before recruitment; scheduled for chemotherapy; stage M0; performance status > 60
  • OTHER KEY SAMPLE CHARACTERISTICS: No contraindications for physical activity


  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Netherlands

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Two-arm, randomized controlled trial using computer generated 1:1 randomization

Measurement Instruments/Methods

  • Quantitative data of outcome assessments at baseline, 18, and 36 weeks postintervention.
  • Fatigue: Multidisciplinary Fatigue Inventory (MFI) and Fatigue Quality List (FQL
  • Quality of Life: EORTC QOL Core-30 and SF-36®
  • Anxiety/Depression: Validated Dutch language version of the 20-item Hospital Anxiety and Depression Scale
  • Aerobic capacity by cardiopulmonary exercise test with continuous breathing gas analysis; thigh muscle strength by Cybex dynameter; handgrip strength by mechanical handgrip dynameter; body weight/height and physical activity level by Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH)


Effects were based on an intention-to-treat analysis using within-group and between-group differences. On the MFI, the only between-group difference seen was a lower increase in physical fatigue at 18 weeks in the intervention group. Although there were decreases in general and mental fatigue in the intervention group at 18 weeks, there was no significant between-group differences. There was no between-group difference on the FQL. The EORTC and Hospital Anxiety/Depression Scale showed decreased QOL, decreased anxiety, and increased depression in both groups at 18 weeks with no between-group difference and improvement in both groups at 36 weeks with decreased improvement in the intervention group. Aerobic capacity and muscle strength were improved in the intervention group at 18 weeks but not at 36 weeks.


An exercise program offered early in the treatment phase of breast cancer appears to positively impact physical fatigue, aerobic capacity, and muscle strength.


  • Key sample group differences that could influence results
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals of 10% or greater 
  • Other limitations/explanation:  The control group may have had a high baseline activity level that continued throughout the study. Multiple measurements make interpretation difficult. Requires resources to implement exercise program.

Nursing Implications

There is an opportunity to continue to study the effect of exercise on fatigue in all patients with cancer. It may be challenging to implement a structured exercise program in clinical practice.