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

Dimeo 2004.

Study characteristics
Methods Study design: RCT
Number randomized: 72; 34 to the exercise group and 35 to the control group
Study start and stop dates: not reported
Length of intervention: 3 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: lung cancer (n = 27), gastrointestinal cancer (n = 42)
Cancer stage, n:
  • exercise group: Stage I, 10; Stage II, 13; Stage III, 8; Stage IV, 3

  • control group: Stage I, 8; Stage II, 15; Stage III, 8; Stage IV, 4


Time since cancer diagnosis, mean (SD) days:
  • exercise group: 211 (24.5) days

  • control group: 174 (15.6) days


Time beyond active treatment, mean (SD) days:
  • exercise group: 126 (153) days

  • control group: 134 (151) days


Inclusion criteria:
  • 30 to 75 years old

  • ECOG score 0 to 2

  • surgical intervention for a histologically confirmed lung or gastrointestinal tumor

  • understanding of written German  


Eligibility criterion related to interest or ability to exercise, or both:
  • none reported


Exclusion criteria:
  • bone metastasis

  • diabetes mellitus

  • impaired left ventricular function

  • coronary heart disease

  • liver or kidney dysfunction

  • psychiatric condition

  • rheumatic disease

  • hemoglobin concentration <10 g/dL

  • ongoing chemotherapy, radiation therapy or immune therapy 


Gender:
  • exercise group: 26 male, 9 female

  • control group: 25 male, 10 female


Current age, mean (SD) years
  • exercise group: 55.1 (10) years

  • control group: 60.0 (9.5) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level: not reported
SES: not reported
Employment status: not reported
Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Interventions 34 participants assigned to the exercise group, including:
  • stationary biking


Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: 80% of the maximal HR in the stress test
Frequency: 5 times per week
Duration of session: 30 minutes
Duration of exercise program: 3 weeks
Total number of exercise sessions: 15
Format: group
Facility: facility‐based
Professionally led: not clear, but supervised by an physician in the same room
Adherence: not reported
35 participants assigned to the control group, including:
  • progressive relaxation training group (45 minutes 3 times per week for 3 weeks)


Contamination of control group: not reported
Outcomes Outcome: QoL outcomes, using:
  • fatigue subsection of the EORTC QLQ‐C30 Version 2, including 30 questions to evaluate emotional, cognitive, physical and social functioning (function scales), and severity of fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, and constipation/diarrhea (symptom scales)


Subgroups: differences between participants with lung and gastrointestinal tumors. No differences found, so combined data from both groups
Outcomes were measured at baseline and 3 weeks (end of the intervention):
  • exercise group: n = 34 at baseline, n = 31 at 3 weeks

  • control group, n = 35 at baseline, n = 35 at 3 weeks


Adverse events: 3 participants with thrombosis and infection in the exercise group
Notes Country: Germany
Setting: Laboratory
Funding: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random number list
Allocation concealment (selection bias) Low risk "The randomisation sequence was concealed until assignment of interventions"
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 Low risk 3 patients in the exercise group were admitted to the hospital for the treatment of a concurrent disease (thrombosis, infection). Data for the 3 patients who did not complete the questionnaire after the intervention were evaluated using the "worst rank assumption"
Selective reporting (reporting bias) Low risk There appears to be no selective reporting of outcomes
Other bias High risk Demographic information not reported