Binder 2004.
Study characteristics | ||
Methods | Randomised trial: use of a computer‐generated algorithm and block design, stratified by type of surgery (hemiarthroplasty or internal fixation) | |
Participants | Community‐dwellers, St Louis, Missouri, USA Period of study: August 1998 to May 2003 90 participants Inclusion: physically frail people (modified Physical Performance Test score of 12 to 28 and ADL difficulty) aged 65 years or over with a surgically‐repaired proximal femoral fracture in the previous 16 weeks who had completed standard physical therapy. Informed consent Exclusion: pathological fracture, contralateral hip fracture, dementia or cognitive impairment, inability to walk 50 feet, visual or hearing impairments interfering with participation, other major medical conditions (cardiopulmonary or neuromuscular disease), taking medication for osteoporosis, on hormone replacement therapy, terminally ill Age: mean 80 years (range not given) % male: 26 Number lost to follow‐up: 5 (2 due to personal reasons, 2 due to medical problems, 1 died) | |
Interventions | Started after end of standard physical therapy.
1. Six months of supervised exercise carried out 3 times weekly. For the first 3 months, small group (2 to 5 participants) progressive exercise for flexibility, balance, co‐ordination, movement speed, strength and endurance led by a physical therapist. After the first 3 months, progressive resistance training was added (progressed by end of 1 month to 3 sets of 8 to 12 repetitions at 85% to 100% of initial 1 RM voluntary strength.
versus
2. Low‐intensity, non‐progressive home exercise programme carried out 3 times weekly after a 1‐hour training session, plus monthly group sessions and weekly 10‐minute telephone calls. Additional interventions for both groups: monitoring and instruction by dietitian if indicated, and vitamin D if indicated at baseline. All received calcium and multi‐vitamin tablets. |
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Outcomes | Length of follow‐up: 6 months Physical Performance Test score (modified) Functional Status Questionnaire score Instrumental Activities of Daily Living score Basic Activities of Daily Living score Use of assistive gait devices Knee extension strength Fast walking speed Single limb stance time Berg Balance Scale SF‐36 (health, physical function, social subscales) Hip Rating Questionnaire Adherence Adverse events and subsequent fractures Mortality |
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Notes |
Host 2007 reported data only from intervention group participants (31/46 participants) who had completed at least 30 sessions in each of the two 3‐month exercise phases. Measured adherence Funding: National Institute of Aging grant R01 G15795, the Washington University General Clinical Research Center grant 5‐M01 RR00036, the Washington University Clinical Nutrition Research Center grant P30 DK56341, and the Barnes Jewish Hospital Foundation. Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random assignment ... was performed on completion of the baseline assessments within strata, defined as the types of surgical repair procedure (hemiarthroplasty vs open reduction internal fixation), using a computer generated algorithm and block design." |
Allocation concealment (selection bias) | Unclear risk | No clear indication of allocation concealment |
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 | There was blinding of outcome assessors: "the research staff who conducted the assessments were not involved in exercise training and were blinded to group assignment". |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | Binding relating to attribution of study related/unrelated causes of medical problems or fractures is uncertain. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | There was blinding of outcome assessors: "the research staff who conducted the assessments were not involved in exercise training and were blinded to group assignment". |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Unclear risk | Five of the 90 participants were lost to follow‐up at 6 months. The last observation for these 5 participants was carried forward and an intention‐to‐treat analysis was conducted with data for the whole trial population. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Mortality follow‐up adequate |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | Unclear risk | Five of the 90 participants were lost to follow‐up at 6 months. The last observation for these 5 participants was carried forward and an intention‐to‐treat analysis was conducted with data for the whole trial population. |
Selective reporting (reporting bias) | Low risk | Pre‐trial completion information shows consistent primary outcome |
Free from baseline imbalance bias? | Low risk | Comprehensive breakdown of characteristics without significant differences |
Free from performance bias due to non‐trial interventions? | Low risk | Measures taken to counteract differences in social contact in the control group by weekly phone calls |