Morris 2017.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: home, Australia N = 133 Sample: recruited via hospital‐based neurologists and the state Parkinson’s support group (40% women) Age (years): mean (SD) intervention group 71.0 (8), control group 71.0 (10) Inclusion criteria: diagnosis of idiopathic PD; modified HY stage ≤ 4; community dwelling Exclusion criteria: cognitive impairment (Mini Mental State Examination < 24); other health conditions that preclude safe participation in the exercise program; insufficient English to follow instructions; an unwillingness to be assessed and treated at home Disease severity at baseline: HY stage 1 to 4, MDS‐UPDRS motor score mean (SD) 35.5 (15) |
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Interventions | Exercise plus education 1. Exercise: home program comprised of progressive resistance strength training (lower limb and trunk), movement strategy training and falls prevention education.Supervised by a therapist who was guided by a physiotherapist (60 minutes, 1x/week for 6 weeks). Plus, unsupervised session prescribed by a physiotherapist (60 minutes, 1x/week for 6 weeks) 2. Control: non‐specific life skills program. Delivered by trained allied health professionals, including occupational therapists, physiotherapists and speech pathologists with no contents related to physical activity, exercise, walking, or fall risk education at comparable length of the intervention group. Plus, self‐directed homework sessions at comparable length of the intervention group |
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Outcomes | 1. Rate of falls 2. Number of fallers 3. Number reporting a fall‐related fracture 4. Quality of life (PDQ39 and EQ‐5D‐3L) Economic analysis 1. Cost of delivering the intervention 2. Cost of fall‐related injury Other outcomes reported but not included in this review |
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Duration of the study | 12 months | |
Funding source | National Health and Medical Research Council Project Grant (no. 509129) | |
Notes | Fall data collected: from the initial pre‐intervention assessment until the follow‐up assessment 12 months after the intervention by monthly falls diaries Economic analysis reported in AUD dollar (price year 2016, hospital costs 20112/13) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A random component in the sequence generation was described. Quote: "Randomisation was stratified according to referral source, and performed by an independent entity using a computerised random number generator.” |
Allocation concealment (selection bias) | Low risk | Allocation concealment was described as by central allocation. Quote: "Randomisation was stratified according to referral source, and performed by an independent entity using a computerised random number generator.” |
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. |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | Insufficient information to permit judgement. Fractures were collected as injurious falls as part of the falls diaries, with injurious falls “defined as any fall that required medical attention or healthcare utilization,” however fractures were self‐reported and not confirmed by the results of radiological examination or from primary care case records. |
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) | Low risk | The study protocol is available (ACTRN12608000390381) and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way. |
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: “...via monthly falls calendars returned via pre‐paid mail. Each participant was required to record any falls incidents by marking the date on the calendar and indicating whether the fall was injurious (defined as any fall that required medical attention or healthcare utilisation). Telephone calls were made to remind participants to return their calendars and to investigate any injurious falls.” |