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

Donnelly 2011.

Study characteristics
Methods Study design: RCT
Number randomized: 33; 16 to the exercise group and 17 to the control group
Study start and stop dates: recruitment form June 2008 to March 2009
Length of intervention: 12 weeks
Length of follow‐up: 6 months
Participants Type cancer, n (%): gynecologic cancers (ovarian, endometrial, uterine, cervical, or mixed)
  • exercise group: ovarian, 6 (37.5%); endometrial, 6 (37.5%); cervical, 2 (12.5%); mixed, 1 (12.5%)

  • control group: ovarian, 6 (35.3%); endometrial, 5 (29.4%); cervical, 3 (17.6%); mixed, 2 (11.8%)


Cancer stage, stage I to III, n (%):
  • exercise group: Stage I, 7 (43.8%); Stage II, 7 (43.8%); Stage III, 2 (12.5%)

  • control group: Stage I, 9 (52.9%); Stage II, 3 (17.6%); Stage III, 5 (29.4%)


Time since cancer diagnosis, mean (SD) months:
  • exercise group: 8.7 (9.6) months

  • control group: 8.6 (8.9) months


Time in active treatment: some women still receiving treatment
 Inclusion criteria:
  • women

  • ≥ 18 years old

  • diagnosis of gynecologic cancer (Stage I to III)

  • completed surgery and either undergoing or completed anticancer treatment

  • within 3 years of diagnosis

  • report of mild to severe fatigue


Eligibility criterion related to interest or ability, or both, to exercise:
  • currently sedentary (i.e. vigorous physical activity < 20 minutes/week or moderate physical activity < 60 minutes/week for the past 6 months) was inclusionary


Exclusion criteria:
  • current medical or psychiatric illness (i.e. unstable cardiovascular disease, uncontrolled hypertension, diabetes or respiratory disease, severe mental illness, cognitive dysfunction or orthopedic problems)

  • participation in other intervention trials

  • previous diagnosis of cancer

  • another fatigue‐related comorbidity (fibromyalgia, chronic fatigue syndrome, multiple sclerosis, myalgic encephalopathy, lupus, or arthritis)


Gender: female
Current age, mean (SD) years:
  • exercise group: 53.5 (8.7) years

  • control group: 52.1 (11.8) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level: not reported
SES: not reported
Employment status, n (%):
  • exercise group: full/part‐time, 1 (6.3%); sick leave, 9 (56.3%); housewife, 2 (12.5%); retired, 4 (25.0%)

  • control group: full/part‐time, 3 (17.6%); sick leave, 8 (47.1%); housewife, 2 (11.8%); retired, 4 (23.5%)


Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Interventions 16 participants assigned to the exercise intervention, including:
  • physical activity, including walking and strengthening exercises, implemented by an initial, individual face to face consultation with a physical therapist and physical activity consultations guidelines followed by weekly telephone calls for 10 weeks, a final face‐to‐face consultation at week 12, and 2 monthly follow‐up calls


Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: moderate
Frequency: aim to meet physical activity guidelines (30 minutes of physical activity on at least 5 days per week)
Duration of individual sessions: 30 minutes
Duration of exercise program: 12 weeks
Total number of exercise sessions: maximum of 60 sessions
Format: individual
Facility: home
Professionally led with initial consultation with a professional physical therapist
17 participants assigned to control group, including:
  • usual care

  • telephone calls at same time and length as exercise group


Adherence: 44% of all participants, or 58% of all individuals who remained medically unfit to take part
Contamination of control group: unclear
Outcomes Primary outcome:
  • fatigue, assessed using the MFSI‐SF and the FACIT‐F subscale


Secondary outcomes:
  • QoL, assessed using the FACT‐G scale

  • depression, assessed using the BDI‐II

  • positive and negative affect, assessed using the PANAS

  • sleep dysfunction, assessed using the PSQI


Outcomes were measured at baseline, 12 weeks (end of intervention), and 6‐month follow‐up (9 months after baseline):
  • exercise group: n = 16 at baseline, n = 15 at 12 weeks, n = 12 at 6‐month follow‐up

  • control group: n = 17 at baseline, n = 17 at 12 weeks, n = 17 at 6‐month follow‐up


Subgroup analysis: none reported
Adverse events:
  • exercise group: lung metastasis (n = 1), pulmonary embolism (n = 1), heart palpitations (n = 1)

  • control group: none reported

Notes Country: UK
Funding: Department of Employment and Learning, Northern Ireland
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers table was used to generate the allocation sequence
Allocation concealment (selection bias) Low risk Allocation was concealed in sequentially numbered opaque envelopes
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 The outcome assessor was blinded to the study allocation
Incomplete outcome data (attrition bias)
All outcomes Low risk The study used ITT analyses
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