Cormie 2013.
Study characteristics | ||
Methods |
Study design: randomised controlled trial Study grouping: parallel group |
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Participants |
Baseline characteristics 100% men Usual care
Exercise
Inclusion criteria: men with a histological diagnosis of prostate cancer, established bone metastatic disease. Participants required clearance from their treating physician to participate Exclusion criteria: moderate‐to‐severe pain that limited activities of daily living or had musculoskeletal, cardiovascular, neurological (or a combination of these) disorders that could prevent them from exercising Group differences: none |
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Interventions |
Usual care
Exercise
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Outcomes |
Knee extension
Timed Up‐and‐Go Test
Balance (Sensory Organisation Test)
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Identification |
Sponsorship source: Cancer Council of Western Australia Country: Australia Setting: Exercise Clinic Comments: no comment Author's name: P Cormie Institution: Edith Cowan University Health and Wellness Institute E‐mail: p.cormie@ecu.edu.au Address: 270 Joondalup Drive, Joondalup, Western Australia, 6027 |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Following familiarisation and baseline testing sessions, participants were randomised into 2 arms: exercise or usual care. Stratification for age was carried out and participants were randomised in an allocation ratio of 1:1 using a random assignment computer program |
Allocation concealment (selection bias) | Low risk | Quote: "The project coordinator and exercise physiologists involved in assigning participants to groups were blinded to the allocation sequence." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded as it is obvious if intervention was applied. This confers high risk of bias, despite attempts to blind the assessors |
Blinding of outcome assessment (detection bias) | Unclear risk | There was no mention of whether assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data were not collected for 25% of participants for 2 outcomes (400‐m walk and leg extension) due to femur bone metastases |
Selective outcome reporting (reporting bias) | Unclear risk | Protocol not available, insufficient evidence to make a decision |
Size of study | High risk | Fewer than 50 participants per treatment arm |
Other sources of bias | Low risk | Study appeared free of other sources of bias |