Hauer 2002.
Study characteristics | ||
Methods | Randomised controlled trial using a protected random number system; stratified by hip‐ or lower‐extremity fracture surgery and non‐hip‐ or lower‐extremity fracture patients (see Notes) | |
Participants | Heidelberg, Germany Period of study: not stated, but trial may have started around 1997 28 female participants Inclusion: females aged ≥ 75 years (25 with a fall‐related hip fracture and 3 with elective hip surgery) who had experienced a recent injurious fall. Written informed consent and permission from orthopaedic surgeon Exclusion: acute neurological impairment, severe cardiovascular disease, unstable chronic or terminal illness, major depression, severe cognitive impairment, severe musculoskeletal impairment Age: mean 81 years (range not stated) % male: none Number lost to follow‐up: 4 (3 didn't start exercises and 1 dropped out) | |
Interventions | Started immediately upon hospital discharge.
1. 12‐week regimen of intensive physical training (lower extremity progressive resistance training, progressive functional and balance training). All exercise sessions took place in training groups (4 to 6 participants) supervised by a therapeutic recreation specialist. Each session: 1.5 hours of resistance training (with recovery breaks) and 45 minutes of balance/functional training. Intensity of strength training adjusted to 70% to 90% of individual maximal workload. Basic functions such as walking, stepping or balancing were trained progressively with increasing complexity.
versus
2. Placebo motor activity: 1‐hour sessions of activities such as flexibility exercise, callisthenics, ball games and memory tasks while seated. Both regimens, taking place 3 times a week, started on average 4 to 5 weeks after surgery upon discharge from inpatient rehabilitation. Both groups received identical additional physiotherapy (mainly massage, stretching and application of heat or ice) twice weekly for 25 minutes: strength and balance training was excluded from these sessions. |
|
Outcomes | Length of follow‐up: 6 months (12 weeks + 3 months) Walking velocity and cadence Independent weight bearing Performance‐orientated motor assessment Box step Functional Reach Timed Up and Go test Chair and stair rises Activities of daily living; sports and household activities Muscle strength: leg‐press, leg‐extensor, leg flexor, ankle‐plantar flexion, hand grip strength (non‐trained muscle group) Loss of independence Subjective fear of falling Subjective walking steadiness Emotional state: depression, morale and handicap scales Adherence |
|
Notes | Measured adherence This trial was excluded from versions of this review up to Issue 3, 2004 because the intervention began after the early postoperative period covered by this review, which then focused on early postoperative rehabilitation. Trial actually included 57 people who had experienced an injurious fall. One report of the trial gave the results for the subgroup of 28 participants who had hip surgery. Of these, 25 had surgery for a fall‐related hip fracture and 3 had elective hip surgery. The patient characteristics of the latter 3 women were confirmed as being essentially similar to those of the 25 women with hip fracture. A 2‐year follow‐up of the trial is available but only for the whole trial population. Further information, including method of randomisation, received from lead trialist on 05 March 2004 and 24 June 2004 Funding: grant from Ministerium fur Wissenschaft, Forschung und Kunst Baden‐Wuerttemberg and the University of Heidelberg Conflict of interest: none declared |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was performed .... using a protected random number system" |
Allocation concealment (selection bias) | Low risk | "Randomization was performed by an external person who did not participate in the study using a protected random number system" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Care providers providing the intervention and the 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 | "Main outcome variables were documented by a person blinded to the patients' group assignment." |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | "Main outcome variables were documented by a person blinded to the patients' group assignment." |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | High risk | Efforts had been made to collect outcome data for the 4 dropouts, 3 of whom did not start the exercises and 1 who discontinued their exercises. However, these data were not available. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Unclear risk | While all participants were accounted for, there were incomplete data on complications (although: 'minor') and long‐term follow‐up. |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | High risk | Efforts had been made to collect outcome data for the 4 dropouts, 3 of whom did not start the exercises and 1 who discontinued their exercises. However, these data were not available. |
Selective reporting (reporting bias) | Unclear risk | Unclear. However, the 3 main reports of the trial were consistent in the reported outcomes and the author provided clarification on some of the outcome measures used. |
Free from baseline imbalance bias? | Low risk | Baseline characteristics were similar in the 2 groups. |
Free from performance bias due to non‐trial interventions? | Low risk | There was no cause for concern. |