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. 2012 Aug 15;2012(8):CD008465. doi: 10.1002/14651858.CD008465.pub2

Tang 2010.

Study characteristics
Methods Study design: RCT
Number randomized: 72; 37 to the exercise group and 35 to the control group
Study start and stop dates: not reported
Length of intervention: 8 weeks
Length of follow‐up: 1 and 2 months
Participants Type cancer, n (%):
  • exercise group: breast, 23 (63.9%); gastrointestinal, 6 (16.7%); nasopharyngeal, 4 (11.1%); lung, 0 (0%); other, 3 (8.3%)

  • control group: breast, 16 (45.7%); gastrointestinal, 5 (14.3%); nasopharyngeal, 3 (8.6%); lung, 4 (11.4%); other, 7 (20%)


Time since cancer diagnosis, mean (SD) years:
  • exercise group: 3.56 (3.92) years

  • control group: 4.13 (4.06) years


Time in active treatment, undergoing cancer treatment, n (%):
  • exercise group: 7 (19.4%)

  • control group: 14 (40.0%)


 Inclusion criteria:
  • ≥ 18 years old

  • diagnosed with cancer

  • complaint of sleep disturbance with a PSQI score > 5

  • approved for participation by their oncologist

  • able to communicate in Mandarin or Taiwanese


Eligibility criterion related to interest or ability, or both, to exercise:
  • neuromuscular deficits that would contraindicate a walking exercise intervention

  • have not regularly undertaken more than 1 session of moderate‐intensity exercise each week over the past 6 months


Exclusion criteria:
  • uncontrolled hypertension, cardiac, or psychiatric illness

  • blood pressure > 140/90 mmHg


Gender, n (%):
  • exercise group: male, 5 (13.9%); female, 31 (86.1%)

  • control group: male, 12 (34.3%); female, 23 (65.7%)


Current age, mean (SD) years:
  • exercise group: 47.36 (10.14) years

  • control group: 56.37 (12.43) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level, mean (SD) years:
  • exercise group: 9.97 (3.67) years

  • control group: 8.26 (4.66) years


SES: not reported
Employment status, n (%):
  • exercise group: working, 13 (36.1%); not working, 23 (63.9%)

  • control group: working, 10 (28.6%); not working, 25 (71.4%)


Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Interventions 37 participants assigned to a walking exercise intervention, including:
  • instructions to walk briskly (at a pace that was faster than normal), starting with a 5‐minute warm‐up (walking slowly) and finishing with a 5‐minute cool‐down after completing the 30‐minute walk

  • exercise booklet ‐ written material for home use focusing on safety and proper technique


Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: rating of perceived exertion between 11 and 13, with a rating of 6 = resting and 20 = very, very hard
Frequency: 3 times per week
Duration of individual sessions: 30 minutes plus 5 minutes warm‐up and 5 minutes cool‐down
Duration of exercise program: 8 weeks
Total number of exercise sessions: 24 sessions
Format: individual
Facility: home
Not professionally led
35 participants assigned to the control group, including:
  • instructions to maintain current lifestyle for 8 weeks

  • instructions to record in a diary provided by the researchers any exercise taken beyond what they normally do

  • invited to begin their own walking program following study completion at 8 weeks


Adherence: 32/36 (89%) reached an adherence rate of at least 50%. The mean (SD) number of complete exercise sessions was 20.03 (6.60)
Contamination of control group: not reported
Outcomes Primary outcome:
  •  sleep quality, assessed using the PSQI


Secondary outcomes included:
  • QoL, measured using the PCS and MCS subscales of the MOS SF‐36


Outcomes were measured at baseline, 1 month, and 2 months:
  • exercise group: n = 37 at baseline, n = 35 at 1 month, n = 36 at 2 months

  • control group: n = 35 at baseline, n = 35 at 1 month, n = 35 at 2 months


Subgroup analysis: none specified
Adverse events: none reported
Notes Country: Taiwan
Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation sequence was generated using a table of random numbers
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 conceal allocation to the intervention from the participants
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 The study was analyzed on an ITT basis. Missing observations, including those incurred by participant drop‐outs, were imputed by the "last observation carried forward" method. The disproportionate attrition from the intervention group places the study at a high risk of bias
Selective reporting (reporting bias) Low risk There appears to be no selective reporting of outcomes
Other bias Low risk The trial appears to be free of other problems that could put it at a high risk of bias