Sherrington 2003.
Study characteristics | ||
Methods | Randomised trial: use of random numbers, balanced within blocks of 6 participants. | |
Participants | Inpatient rehabilitation wards at Bankstown‐Lidcombe Hospital, Sydney, Australia Period of study: January 1997 to December 1999 80 participants Inclusion: people aged 60 years or over with a fall‐related hip fracture who were admitted to rehabilitation wards after surgery; written consent Exclusion: unable to complete assessment and participate in exercise programme due to a) cognitive impairment (assessed by observation), b) major medical conditions, or c) complications from fracture (if directed to be non‐weight bearing or touch‐weight bearing due to problems with fracture fixation). Age: mean 81 years (range 64 to 98 years) % male: 32 Number lost to follow‐up: 3 (1 withdrew consent; 2 with actual or suspected problems with fracture fixation precluding their further participation) | |
Interventions | Early postoperative rehabilitation. Baseline assessment at mean 18.3 days from fracture. The programme commenced while the participant was on the rehabilitation ward and was carried out each weekday in the rehabilitation gymnasium. Participants (21) were advised to continue the programme at home if discharged before the final assessment.
1. Two‐week programmes of weight‐bearing (weight‐bearing position with support as required) exercise prescribed by a physiotherapist. Exercises were sit‐to‐stand, lateral step‐up, forward step‐up‐and‐over, forward foot taps, and a stepping grid. Exercises initially conducted with support of a walking frame or adjustable‐height tables. Exercises progressed by increasing the number of repetitions, lessening the hand support, increasing the height of blocks, decreasing height of surface from which the participants was standing up, etc.
versus
2. Non‐weight‐bearing (performed in the supine position) exercise prescribed by a physiotherapist. Exercises were hip abduction, hip flexion, hip/knee flexion/extension, end of range knee extension, ankle dorsiflexion/plantarflexion. Exercises were progressed by increasing the number of repetitions undertaken. For both groups, the treating physiotherapist chose several initial exercises, then added extra exercises in keeping with the participant's capability. Number of repetitions was established on the basis of the participant's initial performance (ranged from 5 to 30 for a single exercise). Participants were encouraged to take prescribed pain relief before exercising. All participants also received usual physiotherapy intervention involving practice of walking and assessment of tasks needed for discharge (bed mobility, sit‐to‐stand and stair climbing), and usual care from other health professionals (nursing staff, social workers, etc). |
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Outcomes | Length of follow‐up: 2 weeks Walking ability: use of supports Gait: walking velocity, step length, force plate weight‐bearing Strength: hip abduction and flexion and knee extension Balance: functional reach, step test and sway Functional performance measures Sit‐to‐stand x5 Compliance and assessment of exercises Subjectively‐assessed (use of ordinal scales): risk of falling, balance, pain, sleep quality, health Fracture fixation problems Length of hospital stay |
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Notes | This trial, previously listed in Ongoing studies under Sherrington 2002, was performed as part of Cathie Sherrington's PhD work. Additional information provided 15 January 2004 by Cathie Sherrington included further details of method of randomisation and data for self‐assessed outcomes. Funding: National Health and Medical Research Council; Health Research Foundation Sydney South West; Arthritis Foundation of Australia. Conflict of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomised into one of two exercise groups using a random number table and randomisation in blocks of six." |
Allocation concealment (selection bias) | Low risk | "Subjects were assigned into groups using a concealed randomisation method". Clarification of method by personal communication: "This method involved a list of group allocation by subject number on which group allocation for each subject was concealed by a separate piece of opaque paper. Once the subject had agreed to participate in the trial, one piece of paper was removed to reveal the group allocation for the subject in question without revealing the allocation for subsequent subjects." |
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 | High risk | Assessor was not blinded to group allocation. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | Unlikely to be affected by the lack of blinding |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Unclear risk | Intention‐to‐treat analysis was done and a participant flow diagram provided. However, the denominators for various outcomes were quite varied. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Unclear risk | Very short follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Bias unlikely but protocol not available |
Free from baseline imbalance bias? | Low risk | Baseline comparability evident |
Free from performance bias due to non‐trial interventions? | Low risk | Care other than interventions under test comparable in both groups |