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

Heim 2007.

Study characteristics
Methods Study design: quasi‐RCT
Number randomized: 63; 32 assigned to the exercise group and 31 to the control group
Study start and stop dates: not reported
Length of intervention: unclear
Length of follow‐up: 3 months' postrehabilitation
Participants Type cancer: breast cancer
Time since cancer diagnosis: not reported
Time beyond active treatment: not reported, but at least 6 weeks since surgery or chemotherapy
Inclusion criteria:
  • score of 4 or more on a linear analog scale evaluating fatigue ranging in value from 0 to 10


Eligibility criterion related to interest or ability to exercise, or both: not reported
Exclusion criteria:
  • psychiatric condition

  • < 6 weeks since surgery or chemotherapy


Gender: female
Current age, n (%):
  • exercise group: 31 to 50 years, 14 (44%); 51 to 70 years, 18 (56%)

  • control group: 31 to 50 years, 18 (58%); 51 to 70 years, 13 (42%)


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level: not reported
SES: not reported
Employment status, n (%):
  • exercise group: working, professional life, 19 (59%)

  • control group: working, professional life, 23 (74%)


Comorbidities: not reported
Past exercise history (before disease), n (%):
  • exercise group: no sports, 8 (25%); < 1 hour per week, 11 (34%); 1 to 2 hours per week, 11 (34%); ≥ 3 hours per week, 2 (6%)

  • control group: no sports, 8 (26%); < 1 hour per week, 10 (32%); 1 to 2 hours per week, 10 (32%); ≥ 3 hours per week, 3 (10%)


On hormone therapy: none
Interventions 32 participants assigned to the exercise intervention, including:
  • educational program, physical therapy, group exercise, and psycho‐oncologic interventions

  • brochure with instructions for 9 muscle strength and 9 stretching exercises for all large muscle groups, demonstrated by instructor

  • instructions for aerobic exercises (walking program), coordination, and relaxation


Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: not reported
Frequency: instructions were to complete strength training 3 times per week and aerobic exercise for 30 minutes twice per week
Duration of exercise session: not reported
Duration of exercise program: not reported
Total number of exercise sessions: not reported
Format: individual
Facility: inpatient rehabilitation center, but exercises could also be completed at home
Professionally led: initial instruction and printed brochures, but no further instruction
Adherence: assessed as percentage (where adherence to program was equal to 100%), adherence to:
  • muscle strength was 26% at end of rehabilitation and 37% at 3 months after rehabilitation

  • stretching was 30% at end of rehabilitation and 42% at 3 months after rehabilitation

  • aerobic exercises were 163% at end of rehabilitation and 192% at 3 months after rehabilitation


31 participants assigned to control group, including:
  • educational program, physical therapy, group exercise, and psycho‐oncological interventions


Contamination of control group: not reported, although this group received group exercises
Outcomes Outcomes: QoL outcomes, including:
  • FACIT

  • HADS

  • MFI

  • questionnaire on physical activity and motivation to perform exercises and sport

  • aerobic capacity, using Harvard step test

  • muscular strength, using Digimax Multifunktionstest


Outcomes were measured at baseline, after rehabilitation and at 3 months, 59 participants with complete data:
  • exercise group: number at baseline not reported, n = 32 at 3 months

  • control group: number at baseline not reported, n = 31 at 3 months

  • total number of participants at 6 months = 59, not reported by group assignment


Adverse events: not reported
Notes Country: Germany
Funding: German Fatigue Society
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "according to their admission to hospital; depending on the alternating weeks they were allocated to the intervention group or the control group."
Allocation concealment (selection bias) High risk Because of alternation, the investigators were aware of the next treatment assignment
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 There were complete data packets for 59 participants, but no information on missing patients.  Also, "More patients in the control group (15) than in the training group (12) did not continue the study"
Selective reporting (reporting bias) Low risk There appears to be no selective reporting of outcomes
Other bias Unclear risk Poorly described study