Sherrington 2020.
Study characteristics | ||
Methods | Randomised controlled trial, New South Wales (NSW), Australia | |
Participants | Community‐dwellers recruited after discharge from 11 hospitals and from community advertising in NSW, Australia Period of study: April 2010 to December 2015. 336 participants (194 with hip fracture, 31 with pelvic fracture, 111 with other fracture) Inclusion: community‐dwellers aged 60+ years within 2 years of lower‐limb or pelvic fracture Exclusion: resided in a high‐care residential facility (nursing home); cognitive impairment (a Folstein Mini Mental State Examination score of < 24); had insufficient English language to understand study procedures; unable to walk more than ten metres despite assistance from a walking aid and/or another person; medical condition precluding exercise; currently receiving a treatment programme from a rehabilitation facility. Age: mean 77.7 (8.7) % male: 24 Number lost to follow‐up: 52 | |
Interventions | 1. Intervention: individualised physiotherapist‐prescribed home programme of weight‐bearing balance and strength exercises, fall prevention advice based on Stepping On programme. 10 home visits (more frequent in first 3 months) and 5 phone calls to implement, review and progress programme. Exercise programme prescribed for 20 to 30 minutes, 3x/week. 2. Control: usual care |
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Outcomes | 12 months Short Physical Performance Battery (score, plus individual components analysed: gait speed, balance, sit to stand x5) Balance (sum of feet together, semi tandem and tandem stance times) Falls Acute Measure for Post Acute Care Pain Mortality Quality of life |
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Notes | Inclusion criteria for study was recent lower‐limb or pelvic fracture. Only data from 194 participants with hip fracture were included in this review. Total n in study = 336. Funding: Australian National Health and Medical Research Council Conflict of interest: Lord: Physiological Profile Assessment instrument is commercially available in Australia; Australian National Health and Medical Research Council funding for salary |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization order was determined using a computer generated random number schedule with randomly permuted block sizes of 2–6". |
Allocation concealment (selection bias) | Low risk | Quote: "Allocation was concealed by using central randomization performed by an investigator not involved in assessments or recruitment and the treatment allocation tables were inaccessible to recruitment staff". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Therapists conducting the intervention and participants were not blinded to the group assignment. Impact of non‐blinding is unclear |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | Quote: "Study staff who conducted interviews and assessments, received calendars and questionnaires, made phone calls and entered data were unaware of group allocation". "Participants were instructed not to inform the assessors of their intervention status, and all exercise equipment was removed prior to the final assessment". |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Quote: "Study staff who conducted interviews and assessments, received calendars and questionnaires, made phone calls and entered data were unaware of group allocation". |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Health‐realated quality of life: blinded assessors. Falls ascertained by the same method in both groups. Participants reporting falls were not blind to group. Blinded assessors recorded and confirmed falls with participants. Impact of unblinded participant reporting of falls unclear |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | Less than 20% of data lost to follow‐up |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Less than 20% of data lost to follow‐up |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Low risk | Less than 20% of data lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Outcomes in trial registry either reported or draft paper states they will be reported in subsequent paper (EuroQol‐5D, Short Form‐12) |
Free from baseline imbalance bias? | Low risk | No notable difference between groups. |
Free from performance bias due to non‐trial interventions? | High risk | Pragmatic trial, yet social contact in intervention arm likely to confound any effect |
Method of ascertaining falls | Low risk | Monthly falls calendar. Participants who did not return calendars or who reported a fall were telephoned by blinded research assistants |