Gao 2014.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: facility, China N = 80 Sample: recruited by screening admissions at the West China Hospital (34.2% women) Age (years): mean (SD) intervention group 69.5 (7.3), control group 68.3 (8.5) Inclusion criteria: diagnosis of idiopathic PD; over 40 years old; able to walk independently; ≥ 1 fall during the past 12 months Exclusion criteria: cognitive impairment (Mini‐mental state examination score < 24); serious medical problem such as heart failure or severe hypertension; unable to endure moderate exercise for 60 minutes Disease severity at baseline: UPDRS motor score mean (SD) 31.2 (10.7) |
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Interventions | Exercise 1. Exercise: 24‐form Yang Style Tai Chi. Group supervised by a Tai Chi instructor (60 minutes, 3x/week for 12 weeks) 2. Control: no intervention |
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Outcomes | 1. Rate of falls 2. Number of fallers Other outcomes reported but not included in this review |
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Duration of the study | 6 months | |
Funding source | No funding | |
Notes | Fall data collected: during the 6 months follow‐up period starting after the end of intervention by monthly phone calls | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement. Method of generating the randomisation list not described. Quote: "Each patient was given a random number following a random number table and ordered by their assigned numbers. The patients were then assigned to groups by taking the first patient in the order list for the Tai Chi group, the next patient for the control group, and so on until all were assigned." |
Allocation concealment (selection bias) | Unclear risk | Unclear if investigators enrolling participants could possibly foresee assignments. Quote: "Each patient was given a random number following a random number table and ordered by their assigned numbers." Insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and intervention (exercise) delivery personnel not blinded to group allocation but impact of non‐blinding unclear. |
Blinding of outcome assessment (detection bias) Falls and fallers | Unclear risk | Unclear if personnel collecting fall information blinded to group allocation. |
Incomplete outcome data (attrition bias) Falls | Low risk | See appendix for method of assessment |
Incomplete outcome data (attrition bias) Fallers | Low risk | See appendix for method of assessment |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’ as unable to find a published protocol or trial registration. |
Method of ascertaining falls (recall bias) Falls and fallers | Low risk | The study used concurrent collection of data about falling with monthly, or more frequent, follow‐up by the researchers. Quote: “A notebook was given to every patient to record the amount and the description of the falls. Every patient was telephoned once a month to get the details about experience of falls such as the number of falls, how and where they fell and the injuries they suffered.” |