Salpakoski 2015.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Community‐dwellers, following discharge from Central Finland Central Hospital Period of study: not stated 81 participants randomised Inclusion: age > 60 years; ambulatory and community‐dwelling; operated for femoral neck or pertrochanteric fracture (International Classification of Diseases code S72.0 or S72.1); living in the city of Jyväskylä or in 9 neighbouring municipalities. Exclusion: living in an institution or confined to bed at the time of the fracture; suffering from severe memory problems (Mini Mental State Examination < 18); alcoholism, severe cardiovascular, pulmonary or progressive (i.e. neoplasm) disease, para‐ or tetraplegic or severe depression (Beck Depression Inventory > 29) Age: mean 80, SD 7.09 % male: 22 Number lost to follow‐up: 4 (control: 2 dropouts; intervention: 1 dropout, 1 died) | |
Interventions | 1. Intervention: 1 year. Promoting mobility after hip fracture (ProMo): standard care and a home‐based, year‐long programme including evaluation/modification of environmental hazards, guidance for safe walking, pain management, progressive home exercise programme and physical activity counselling. Exercise programme = lower‐limb strengthening exercises for the lower limbs (progressed, resistance bands), balance training in standing position, walking exercises and stretching, 30 minutes; strengthening and stretching = 3x/week, balance and walking exercises = 2 to 3x/week. Physical activity counselling = 2 x 30‐minute face‐to‐face sessions and 3 phone contacts, with personal physical activity plan. 2. Control: standard care, included written home exercise programme with 5 to 7 exercises for lower limbs |
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Outcomes | Follow‐up: 12 months Short Physical Performance Battery Berg Balance Scale Timed 10 m walk Perceived difficulties in negotiating stairs. “Are you able to negotiate 1 flight of stairs (5 stairs)?” 5‐item response Difficulty walking 500 m Leg extension power (Nottingham Leg Extensor Power Rig) SF‐36 (HRQoL) (email correspondence: outcomes not available at time of writing) Mortality Independent activities of daily living, sum score |
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Notes | Measured adherence Funding: nil Conflict of interest: nil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A computer‐generated group allocation list was generated by a statistician not involved in the recruitment or data collection. Randomization by sex and by surgical procedure (internal fixation vs arthroplasty) was performed in blocks of 10". |
Allocation concealment (selection bias) | Low risk | "The study group assignments were enclosed in sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and therapists not blind to group allocation but impact of non‐blinding unclear |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | The researchers who collected the outcome measures were blinded to group allocation. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Unclear risk | Unclear how death and complications were recorded |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | Less than 20% of outcome data missing |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Low risk | Less than 20% of outcome data missing |
Selective reporting (reporting bias) | Low risk | Reporting of outcomes as primary and secondary differs in protocol paper (Sipila 2011) and main results paper (Salpakoski 2015). In addition, some components of the primary outcome mobility‐related disability noted in protocol paper (difficulty walking outdoors, 500 m and 2 km) were not reported in results paper. Emailed author 15 July 2019 to ask if the outcomes were analysed. Email received with comprehensive results provided. |
Free from baseline imbalance bias? | Low risk | No imbalance in baseline characteristics |
Free from performance bias due to non‐trial interventions? | Low risk | No evidence that therapists delivering care to each group were different |