Ashburn 2007.
Study characteristics | ||
Methods | RCT | |
Participants | Setting: home, UK N = 142 Sample: recruited from clinical registers of three PD specialists in two National Health Service (NHS) trusts (39% women) Age (years): mean (SD) intervention group 72.7 (9.6), control group 71.6 (8.8) Inclusion criteria: diagnosis of idiopathic PD; independently mobile; living at home in the community; > 1 fall in the previous 12 months; passed a screening test for gross cognitive impairment Exclusion criteria: pain preventing participation in assessments; an acute medical condition Disease severity at baseline: HY stage 2 to 4, UPDRS motor score mean (SD) 21.0 (10.2) |
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Interventions | Exercise 1. Exercise: 6‐week home‐supervised exercises designed with six levels of progression comprising of strength (lower limb), range of movement, balance training and walking exercises. Plus strategy training for falls prevention and movement initiation and compensation. The supervised exercises were performed for 60 minutes, 1x/week for 6 weeks. Plus, home unsupervised exercises (minutes not reported), 7x/week for 6 months 2. Control: usual care (usual care for the vast majority comprised contact with a local PD nurse) |
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Outcomes | 1. Rate of falls (data provided by trial authors on request) 2. Number of fallers 3. Number reporting a fall‐related fracture 4. Quality of life (EQ‐5D) Other outcomes reported but not included in this review |
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Duration of the study | 6 months | |
Funding source | Action Medical Research, and the John and Lucille Van Geest Foundation | |
Notes | Fall data collected: at 8 weeks and 6 months follow‐up by monthly falls diaries | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of generating the randomisation list not described. Quote: "Randomisation was stratified by NHS Trust using blocks of size four." |
Allocation concealment (selection bias) | Low risk | Allocation concealment was described as by central allocation. Quote: "After the baseline assessment by the assessor, the treating physiotherapist obtained the random allocation by telephoning the Medical Statistics Group at the University of Southampton, Southampton, UK.” |
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 were blinded to group allocation. |
Blinding of outcome assessment (detection bias) Fractures | Unclear risk | The evidence for fractures was from self‐reports from participants or carers. Quote: "Participants were also asked to record injuries as a result of falls (cuts and bruises, fractures or other trauma) and whether they attended the hospital, sought other forms of medical help or self‐managed their injuries.” |
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 (ISRCTN63503875) 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: “Fall events that were experienced during the trial period were recorded prospectively using self‐completed diaries. Each month, participants were sent a falls diary sheet, consisting of daily numbered date boxes. Individuals recorded “F” for a “fall” and “NF” for a “near fall”whenever these occurred, and returned the sheets to the secretary in a stamped addressed envelope.” |