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

Mehnert 2011.

Study characteristics
Methods Study design: RCT
Number randomized: 63; 35 to the exercise group and 28 to the control group
Study start and stop dates: not reported
Length of intervention: 10 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: non‐metastatic breast cancer, stages I to III
Stage of cancer, n (%):
  • exercise group: Stage I, 17 (56.7%); Stage IIA, 8 (26.7%); Stage IIB, 3 (10.0%); Stage IIIA, 1 (3.3%); Stage IIIB, 1 (3.3%)

  • control group: Stage I, 13 (46.4%); Stage IIA, 7 (25.0%); Stage IIB, 5 (17.9%); Stage IIIA, 3 (10.7%); Stage IIIB, 0 (0%)


Time since cancer diagnosis: not reported
Time beyond active treatment: at least 4 weeks following chemotherapy, radiation therapy, or both
 Inclusion criteria:
  • 18 to 65 years old

  • primary nonmetastatic breast cancer

  • minimum 4 weeks after completion of chemotherapy, radiation therapy, or both


Eligibility criterion related to interest or ability to exercise, or both:
  • any disorder that could interfere with ability to perform the physical exercise program


Exclusion criteria:
  • severe acute or chronic illness other than cancer (e.g. disorders of the musculoskeletal system)


Gender: female
Current age, mean (SD) years:
  • exercise group: 53.03 (7.40) years

  • control group: 50.64 (9.44) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level, n (%):
  • exercise group: elementary school, 2 (6.9%); junior high school, 17 (58.6%); high school, 2 (6.9%); university degree, 8 (27.6%)

  • control group: elementary school, 4 (14.3%); junior high school, 11 (39.3%); high school, 6 (21.4%); university degree, 7 (25.0%)


SES: not reported
Employment status, n (%):
  • exercise group: employed, 17 (60.7%); retired, 5 (17.8%); housewife, 4 (14.3%); unemployed, 1 (3.6%); unable to work/sick leave, 1 (3.6%)

  • control group: employed, 14 (50.0%); retired, 3 (10.7%); housewife, 4 (14.3%); unemployed, 6 (21.4%); unable to work/sick leave, 1 (3.6%)


Comorbidities: not reported
Past exercise history:
  • exercise group: 19/30 (63.3%) engaged in regular sport and fitness activities for a mean (SD) of 2.3 (1.4) training hours per week

  • control group: 10/28 (35.7%) engaged in regular sport and fitness activities for a mean (SD) of 1.7 (0.9) training hours per week


On hormone therapy: not reported
Interventions 35 participants assigned to a structured physical training program developed to promote muscular strength and exposure, including:
  • gymnastics, movement games, and relaxation

  • moderate walking and jogging conducted outside


Although 35 women were assigned to the exercise intervention, 5 women refused to participate prior to the baseline assessment
Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: maximum of 60% VO2
Frequency: twice per week
Duration of individual sessions: 90 minutes
Duration of exercise program: 10 weeks
Total number of exercise sessions: 20
Format: group
Facility: indoor sports facility and outdoors
Professionally led by trained member of study staff (qualified physical therapist or sport therapist)
28 participants assigned to control group, including:
  • usual care


Adherence: not reported
Contamination of control group: not reported
Outcomes No primary outcome was identified. QoL outcomes included:
  • anxiety, measured using HADS

  • depression, measured using HADS

  • cancer‐specific HRQoL, measured using the EORTC QLQ‐C30 subscale

  • generic HRQoL, measured using MOS SF‐36

  • psychological symptoms, measured using SCL‐90‐R

  • body image, measured using a German version of the BIQ


Outcomes were measured at baseline and 10 weeks:
Different numbers of participants had data at the 2 time points as follows:
Anxiety and depression:
  • exercise group: n = 30 at baseline, n = 30 at 10 weeks

  • control group: n = 28 at baseline, n = 28 at 10 weeks


Individual body Image:
  • exercise group: n = 27 at baseline, n = 27 at 10 weeks

  • control group: n = 27 at baseline, n = 27 at 10 weeks


Social body image:
  • exercise group: n = 30 at baseline, n = 27 at 10 weeks

  • control group: n = 27 at baseline, n = 27 at 10 weeks


Numbers of individuals with data for cancer‐specific HRQoL, generic HRQoL, and psychological symptoms were not reported
Subgroup analysis: none reported
Adverse events: no cancer recurrences or adverse events reported
Notes Country: Germany
Funding: Friedrich and Louise Homann Foundation, Hamburg, Germany
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk It is unclear how the allocation sequence was generated
 
Allocation concealment (selection bias) Low risk The randomization was adequately concealed through external randomization
 
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 It is unclear how missing data were handled. 5 randomized participants were reported to have "cancelled" participation in the exercise group
Selective reporting (reporting bias) Low risk There appears to be no selective reporting of outcomes
Other bias High risk The small sample size and participation in physical exercise by women in the study groups can contribute to bias