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

Payne 2008.

Study characteristics
Methods Study design: RCT
Number randomized: 20; 10 to the exercise group and 10 to the control group
Study start and stop dates: 9‐month period but dates not reported
Length of intervention: 14 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: breast cancer
Time since cancer diagnosis: not reported
Time beyond active treatment: not reported
 Inclusion criteria:
  • postmenopausal women

  • diagnosis of breast cancer

  • receiving hormonal therapy with tamoxifen, anastrozole, or letrozole during the period of recruitment and study enrolment

  • ≥ 55 years old

  • complaints of fatigue

  • speak English

  • KPS score of ≥ 80


Eligibility criterion related to interest or ability to exercise, or both:
  • no neuromuscular deficits


Exclusion criteria:
  • documented history of neurologic deficits or mental illness (e.g. psychotic deficits) within the past year


Gender: female
Current age, mean (SD) years: 64.7 (6.3) years
Age at cancer diagnosis: not reported
Ethnicity/race, n (%): 18 (90%) Caucasian and 2 (10%) African‐American
Education level, n (%): 11th or 12th grade education, 5 (25%); some college level education, 7 (35%); college degree or higher level of education, 8 (40%)
SES, household income, n (%): ≤ USD20,000, 4 (20%); USD20,001 to USD40,000, 5 (25%); USD40,001 to USD60,000, 4 (20%); > USD60,000, 6 (30%); refused to answer 1 (5%)
Employment status, n (%): employed, 3 (15%); homemaker, 1 (5%); retired, 11 (55%); other employment status, 2 (10%); did not provide employment information, 3 (15%)
Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: all used tamoxifen, anastrozole, or letrozole
Interventions 10 participants assigned to the exercise intervention, including:
  • home based walking activity


Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: moderate
Frequency: 4 times per week
Duration of individual sessions: 20 minutes
Duration of exercise program: 14 weeks
Total number of exercise sessions: 56 sessions
Format: individual
Facility: home
Not professionally led, but explained by study coordinator
10 participants assigned to the control group, including:
  • usual care


Adherence: 9 out of the 10 women completed the study, adherence data on number of sessions completed are not specified
Contamination of control group: not reported
Outcomes No primary outcome was identified. QoL outcomes included:
  • fatigue, measured using the Piper Revised Fatigue Scale

  • sleep disturbance, measured using the PSQI

  • depressive symptoms, measured using the CES‐D


Physiologic outcomes included:
  • blood chemistry, including cortisol, serotonin, interleukin‐6, bilirubin markers


Outcomes were measured at baseline, 12 weeks, and 14 weeks:
  • exercise group: n = 10 at baseline, n = 10 at 12 weeks, n = 9 at 14 weeks

  • control group: n = 10 at baseline, n = 9 at 12 weeks, n = 9 at 14 weeks


Subgroup analysis: none reported
Adverse events: none reported
Notes Country: US
Funding: NIH/National Institute of Nursing Research
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Generation of allocation sequence was not described
Allocation concealment (selection bias) Unclear risk Whether the treatment assignment was concealed from study personnel and participants was not described
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 was no description on how missing data were handled. Participants in each group withdrew from the study
Selective reporting (reporting bias) Low risk There is no evidence of selective reporting of outcomes
Other bias High risk Small sample size and low recruitment rate can put study at risk of bias