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. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2

Fillion 2008.

Study characteristics
Methods Study design: RCT
Number randomized: 94; 48 to the exercise group and 46 to the control group
Study start and stop dates: not reported
Length of intervention: 4 weeks
Length of follow‐up: 3 months
Participants Type cancer: breast cancer, stages 0 to III
Time since cancer diagnosis, mean (SD) days:
  • exercise group: 256.7 (101.5) days

  • control group: 256.8 (112.7) days


Time beyond active treatment: no more than 2 years
Inclusion criteria:
  • women diagnosed with an initial nonmetastatic breast cancer

  • completion of initial breast cancer treatment no longer than 2 years before enrolment

  • received 1 series of adjuvant treatments of radiation therapy, or had received radiation therapy in combination with other adjuvant treatments (e.g. chemotherapy or hormonal therapy)

  • understand and speak French

  • live near the cancer center and available to take part in a series of 4 weekly sessions

  • accept the randomization procedure


Eligibility criterion related to interest or ability to exercise, or both:
  • pass revised Physical Activity Readiness Medical Examination

  • obtain the authorization of supervising physician before performing the fitness assessment


Exclusion criteria:
  • clinical levels of depression symptoms, as measured by HADS (score > 10)

  • insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition

  • any symptom of cancer recurrence

  • known severe health problems other than cancer


Gender: female
Current age, mean (SD) years:
  • exercise group: 53.09 (9.65) years

  • control group: 51.84 (10.25) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level, n (%):
  • exercise group: high school, 13 (29.5%); college graduate, 13 (29.5%); university graduate, 18 (40.9%)

  • control group: high school, 15 (34.9%); college graduate, 13 (30.2%); university graduate, 15 (34.9%)


SES, n (%):
  • exercise group: < USD15,000, 2 (5.0%); USD15,000 to USD29,999, 1 (2.5%); USD30,000 to USD44,999, 6 (15.0%); > USD49,999, 31 (77.5%)

  • control group: < USD15,000, 3 (7.5%); USD15,000 to USD29,999, 6 (15.0%); USD30,000 to USD44,999, 5 (12.5%); > USD49,999, 26 (65.0%)


Employment status, n (%):
  • exercise group: full‐time, part‐time, 8 (12.8%); absence due to illness, retired, unemployed, 36 (81.8%)

  • control group: full‐time, part‐time, 16 (37.2%); absence due to illness, retired, unemployed, 27 (62.8%)


Comorbidities: not reported
Past exercise history: not reported
On hormone therapy, tamoxifen, nolvadex, zoladex, arimidex, n (%):
  • exercise group: 29 (65.9%)

  • control group: 35 (81.4%)

Interventions 48 participants assigned to the exercise intervention, including:
  • 4 weekly group meetings of 2.5 hours and 1 short telephone booster session (5 to 15 minutes). 1 hour was devoted to the supervision of walking training by a kinesiologist or a trained research nurse

  • 1.5 hours to the psycho‐educative, fatigue management sessions


Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: unclear
Frequency: 4 times per week
Duration of exercise session: 1 hour
Duration of program: 4 weeks
Total number of exercise sessions: 16
Format: group
Facility: facility and home
Professionally led: kinesiologist led the exercise, and an oncology nurse led the psycho‐educational component
Adherence: 45 of 48 participants completed the full treatment
Co‐intervention: psycho‐educative, fatigue management
46 participants assigned to the control group, including
  • normal activity


Contamination of control group: not reported
Outcomes Primary outcome: fatigue, measured with the General/Physical Fatigue subscale of the MFI
Secondary outcomes: physical measures and QoL measures, including:
  • fitness, measured as submaximal oxygen consumption (Vo2submax), was estimated from the Single‐Stage Treadmill Walking Test

  • QoL, measured with the MOS SF‐12

  • energy level, measured using the Vigor subscale of the shortened Profile of Mood States

  • anxiety and depression, measured using the Profile of Mood States


Outcomes were measured at baseline, 4 weeks, and 3 months:
  • exercise group: n = 48 at baseline, n = 45 at 4 weeks, n = 45 at 3 months

  • control group: n = 46 at baseline, n = 43 at 4 weeks, n = 43 at 3 months


Adverse events, cancer recurrence, n:
exercise group: 2
control group: 1
Notes Country: Canada
Funding: BFonds de Recherche en Sante du Quebec, Investigator Award
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk sequence of randomization was "computer generated"
Allocation concealment (selection bias) Low risk "sealed envelopes, which were concealed to both kinesiologist and patient"
Blinding of participants and personnel (performance bias)
All outcomes High risk Owing to the nature of the intervention, it was not possible to blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking
Blinding of outcome assessment (detection bias)
All outcomes High risk Study personnel and outcome assessors were not masked or blinded to the study interventions
Incomplete outcome data (attrition bias)
All outcomes High risk 4 participants from the exercise group were not included in the analyses (withdrew, n = 1; cancer recurrence, n = 2; metastatic breast cancer diagnosis, n = 1); 3 participants from the control group were not included in the analyses (withdrew, n = 2; cancer recurrence, n = 10)
Selective reporting (reporting bias) Low risk There appears to be no selective reporting of outcomes
Other bias Low risk The trial appears to be free of other problems that could put it at a high risk of bias