Resnick 2007.
Study characteristics | ||
Methods | Randomised trial using computer program. Allocation by independent project co‐ordinator | |
Participants | Community‐dwellers and independent ambulators (at time of fracture) who had completed Medicare‐funded rehabilitation recruited from 9 hospitals in the greater Baltimore area, USA Period of study: August 2000 to September 2005 (last follow‐up) 155 participants (see Notes) Inclusion: female, aged 65 years or over with a non‐pathological fracture which had occurred within 72 hours of hospital admission, who had surgical repair of their hip fracture. Community‐dwellers and independent walkers before fracture. Free of medical problems that would potentially put them at risk of falls when exercising alone at home alone (e.g. neuromuscular conditions). Score of 20 or higher on the Folstein Mini Mental State Examination. Informed consent. Exclusion: angina, myocardial infarction, stroke, heart condition, pulmonary oedema, Paget's disease, uncontrolled diabetes, Parkinson's disease, multiple sclerosis, cancer, severe blindness, seizures, gastrointestinal haemorrhage (many criteria were limited to the previous 6 months). See trial registration document for full list (clinicaltrials.gov/ct2/show/NCT00389844). Age: mean 81 years % male: 0 (all female) Number lost to follow‐up: 42 (25 withdrew, 10 impractical/other, 7 died) | |
Interventions | Planned to initiate the intervention as soon as Medicare‐covered rehabilitation services were completed (generally around 1 month); but start dictated by participants. 1. Exercise‐only component. Exercise sessions with an exercise trainer. Sessions incorporated aerobic exercise using a 'Stairstep' (a 4‐inch stair step with handles on either side for support and balance) for 3 days a week, strengthening exercises for main muscle groups relevant to hip fracture recovery for 2 days a week (11 exercises with Thera‐Band and/or ankle wrist cuff weights up to 3 sets of 10 then weight increased), and stretching exercises (these were part of the warm‐up and cool‐down periods). Time and repetitions individually prescribed. (No encouragement given.) versus 2. The full 'Exercise Plus' programme, which includes the above together with the Plus component (motivational interventions: addition of education about the benefits of exercise from the same exercise trainer using a booklet, verbal encouragement through goal setting and positive reinforcement, medications/heat/ice (for pain), cueing with posters describing the exercises, a 'Goal Form' and a calendar of daily exercise activities. versus 3. Routine care In both treatment groups (1 and 2), visits from the trainer were initially twice a week and then decreased to once a month in the final 4 months of the programme, with weekly telephone calls for those exposed to the 'Plus' (motivation) component of the intervention during the weeks when no visit was scheduled. All visits lasted 1 hour. The maximum number of anticipated visits was 38. |
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Outcomes | Length of follow‐up: 12 months from injury Mortality | |
Notes | Extensive account of rationale published in 2002. Trial funded by the National Institute on Aging and National Institutes of Health. 209 were randomised into 4 groups. The 'Plus' or motivation‐only group (54 participants) is not considered in this review (see Crotty 2010). One participant in the exercise‐only group was excluded because they did not receive surgery. Measured adherence Funding: National Institute on Aging grants R37 AG09901, R01‐AG18668, R01 AG17082; Claude D. Pepper Older Americans Independence Center P60‐AG12583; Thera‐Band Academy for contribution of Thera‐Band1 resistive bands. 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 | "Randomization was performed using a freeware computer program. Patient assignment was blocked by hospital to assure equal probabilities within each hospital being assigned to each of the four study groups. Patients were assigned to groups at random with forced balancing of treatment groups within hospital." |
Allocation concealment (selection bias) | Low risk | "The resulting randomization scheme was given to the project coordinator and patients assigned as they became available at the indicated hospital. The study nurses involved with recruitment and data collection were blind to randomization." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Study participants were not informed of what specific arm of the intervention they were randomized to (i.e. exercise only, plus only, or exercise plus)." Safeguards were not described. Therapists were not blinded to group allocation. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | "The study nurses involved with recruitment and data collection were blind to randomization". |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | "The study nurses involved with recruitment and data collection were blind to randomization". Assessment of these outcome is usually unlikely to be influenced by knowledge of group allocation. |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Unclear risk | While participant flow diagram was provided, more participants (10) in the exercise‐only group refused study follow‐up compared with 2 in the usual care group. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Participant flow diagram provided. |
Selective reporting (reporting bias) | Unclear risk | Retrospective trial registration. Insufficient information but no report of overall health status and muscle strength (as stipulated beforehand) |
Free from baseline imbalance bias? | Low risk | No obvious imbalance (all female) |
Free from performance bias due to non‐trial interventions? | High risk | Time from fracture to first intervention visit from trainer ranged from 28 to 200 days. Participants indicated when they were willing to have their first visit. |