Orwig 2011.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Community‐dwelling women attending 1 of 3 Baltimore‐area hospitals, USA Period of study: November 1998 through September 2004 180 participants Inclusion: Community‐dwelling women, ≥ 65 years age, screened within 15 days of the fracture, completing at least 80% of the baseline survey, admitted within 72 hours of a non‐pathological hip fracture receiving surgical repair, walking without human assistance prior to the fracture, cognitively intact (i.e. score ≥ 20 on the Folstein Mini Mental State Examination) and received orthopedic surgeon clearance Exclusion: pathologic fracture; cardiovascular, neurologic, and respiratory diseases that could interfere with exercising independently at home; diseases of the bone (e.g. Paget disease, osteomalacia); metastatic cancer; cirrhosis; end‐stage renal disease; hardware in the contralateral hip; and conditions that increase risk of falling while exercising independently Age: mean (SD) 82.4 (7) years % male: 0% Number lost to follow‐up: 49 did not have 12‐month follow‐up |
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Interventions | 1. Home exercise. Exercise sessions and a self‐efficacy‐based motivational component. Aerobic exercise using a Stairstep (progressed time and ankle weights), upper and lower limb strengthening programme (progressed with resistance and intensity, aiming for 3 sets of 10 reps), and stretching exercises (20‐ to 30‐minute warm‐up and cool‐down periods). Total of 56 exercise sessions over 12 months, frequency reduced over time, supplemented with telephone calls to remind participants to exercise and address any questions or concerns. Participants were expected to perform aerobic activity at least 3 days/week and strength training 2 days/week for 30 minutes. 2. Usual care. Plus information on bone health and management of osteoporosis. |
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Outcomes | Length of follow‐up: 12 months Mortality Discharge to community Adverse events: re‐admission Adverse events: persistent pain Adverse events: falls Adverse events: treatment‐related *Additional outcomes displayed graphically not extracted Adverse events: surgical complication Other outcomes: discharge to nursing home |
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Notes | Measured adherence Funding: this research was supported by the National Institute on Aging, Bethesda, Maryland (grants R37 AG09901, R01 AG18668, R01 AG17082, T32 AG00262), and the Claude D. Pepper Older Americans Independence Center (grants P60 AG12583 and P30 AG028747). Conflict of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote "PC‐PLAN software37 was used to randomize participants within blocks of 2 or 10" |
Allocation concealment (selection bias) | Unclear risk | Allocation method not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and therapists not blinded to group allocation and the effect of this non‐blinding not clear |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | Study staff conducting assessments were blind to group assignment. Participants obviously not blinded in presence of self‐report outcomes (SF‐36) |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Study staff conducting assessments were blind to group assignment. Assessment of mortality outcome is usually unlikely to be influenced by knowledge of group allocation. |
Blinding of outcome assessment (detection bias) Participant/proxy‐reported outcomes | Unclear risk | Falls ascertained by the same method in both groups. Study staff conducting assessments were blind to group assignment. Impact of unblinded participant reporting of falls unclear |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | High risk | 69% and 77% completed all 3 follow‐up visits. |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | High risk | 69% and 77% completed all 3 follow‐up visits. |
Incomplete outcome data (attrition bias) Participant/proxy‐reported outcomes | High risk | 69% and 77% completed all 3 follow‐up visits. |
Selective reporting (reporting bias) | High risk | Self‐efficacy reported as primary outcome but not included in trial report. Secondary outcomes not reported: dietary intake, time to weight bearing (possibly not enough space in publication, time to exercising reported) |
Free from baseline imbalance bias? | Low risk | Groups balanced at baseline |
Free from performance bias due to non‐trial interventions? | High risk | Home visits may have had a social effect with these community‐dwelling elderly women; some who had cognitive impairment (Mini Mental State Examination 21 to 25) were included in the trial. |
Method of ascertaining falls | Unclear risk | Insufficent data available to make judgement. 'Monthly telephone calls were made to participants to ascertain falls'. |