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. 2018 Jan 29;2018(1):CD011292. doi: 10.1002/14651858.CD011292.pub2

Cerulli 2014.

Methods Study design: single‐centre RCT
 Number randomised: 20; 10 to exercise, 10 to control
 Study start and stop dates: not reported
 Length of intervention: 16 weeks
 Length of follow‐up: to end of intervention
Country: Italy
Participants Age, years (mean SD):
  • Intervention: 45.3 (4.3)

  • Control: 46.0 (2.8)


Stage, n (%):
  • Intervention: stage I, 3 (30); stage II, 5 (50); stage III, 2 (20)

  • Control: stage I, 1 (10); stage II, 5 (50); stage III, 4 (40)


Inclusion criteria:
• Age 40 to 50 years
• Conclusion of all cancer‐related treatments at least 6 months previously
• Mastectomy
• No external physical activity for at least the preceding 12 months
• Medical eligibility for non‐competitive athletic activity
Interventions 10 participants assigned to exercise intervention:
  • All intervention group participants received two 1‐hour therapeutic horse‐riding treatments at an intensity of 65% to 70% of HR maximum (220‐age) per week, for 16 weeks. Each riding session consisted of 3 phases: (1) warm‐up, horse‐caring, and grooming; (2) riding; and (3) unsaddling and grooming activities.


Adherence: not reported
10 assigned to control:
  • Participants randomly assigned to control group were instructed not to begin any new formal physical exercise programme

Outcomes Outcomes:
  • Maximal oxygen consumption (VO₂max) obtained via the Astrand–Rhyming cycle ergometer test

  • Maximal strength of principal muscle groups assessed by an inertial measurement system (Free‐Power; Sensorize, Rome, Italy). Maximal strength evaluated for each of 5 weight lifting machines (Technogym SpA, Cesena, Italy): leg press, leg extension, leg curl, shoulder press, and vertical traction. Participants were asked to perform at least 2 repetitions at 30%, 50%, and 70% of presumed 1RM.

  • Body composition (fat mass % and total body water %) assessed via a portable multi‐frequency digital bioelectrical impedance device (Handy 3000; DS Medica, Milano, Italy)

  • Quality of life assessed via FACT‐G

  • Fatigue assessed by FACT‐F


Numbers of participants assessed:
  • Intervention: baseline, 10; at 16 weeks, 10

  • Control: baseline, 10; at 16 weeks, 10


Adverse events: none reported
Notes Trial registration link: none available
Trial authors contacted: no
Intention‐to‐treat analysis: no dropouts reported
Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomly divided into two groups". It is unclear how the allocation sequence was generated.
Allocation concealment (selection bias) Unclear risk Whether 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 participants.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Whether study personnel and outcome assessors were masked or blinded to study interventions was not reported.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts were reported.
Selective reporting (reporting bias) Low risk No selective reporting of outcomes is apparent.
Other bias Low risk Trial appears to be free of other problems that could put it at high risk of bias.