Martinez‐Velilla 2019.
Study characteristics | ||
Methods | Design: RCT Date of study: Feb 1 2015 to Aug 30 2017 Power calculation: not for delirium outcome Inclusion criteria: Age >=75, Barthel index >=60, mobile with/without assistance, able to communicate Exclusion criteria: LOS< 6 days, severe cognitive decline, terminal illness, uncontrolled arrhythmias, acute PE, recent MI, recent major surgery, extremity bone fracture in the last 3 months |
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Participants | Sample size: 370 Country: Spain Setting: Acute elderly care unit Age: Mean age 87.6 years (SD 4.6) in intervention group; 87.1 years (SD 5.2) in control group Sex: male, 76 (41.1%) in the intervention group, male, 85 (45.9%) in the control group Co‐morbidity: cumulative Illness Rating Scale similar between groups = Intervention group, 13(5), Control group 12(5). No baseline between‐group differences in demographic variables including BMI and number of diseases (includes hypertension, congestive heart failure, osteoarthritis, COPD). Dementia: mean score 22 (SD = 5) in the intervention group, Mean score 23 (SD = 45) in the control group Frailty: not reported |
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Interventions | Intervention: intervention session supervised by an experienced fitness specialist was conducted twice daily (morning and evening) of 20 minutes’ duration during 5 to 7 consecutive days (including weekends). A session was considered completed when 90% or more of the Programmed exercises were successfully performed. Exercises were adapted from the multicomponent physical exercise program Vivifrail to prevent weakness and falls. The morning sessions included individualized supervised progressive resistance, balance, and walking training exercises. The evening session consisted of functional unsupervised exercises using light loads Control: usual care is offered to the patient by the geriatricians of the geriatrics department and consists of standard physiotherapy focused on walking exercises for restoring the functionality conditioned by potentially reversible abnormalities. A formal exercise prescription was not provided at study entry and patients were instructed to continue with the current activity practices through the duration of the study. |
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Outcomes | Outcomes reported ‐Incident delirium using CAM ‐Mortality at 3 months ‐Length of hospital admission (days) ‐ ADL using Barthel index (2 weeks prior to admission to hospital discharge) ‐ Quality of life using EQ5D (baseline to discharge) ‐ New care home admission at discharge (reported as home/institution) ‐ Falls Outcomes from study not reported: none Frequency of outcomes assessment: not reported. |
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Notes | Funding source: Gobierno de Navarra project Resolucion grant., Ministerio de Economia, Industria y Cometitividad, ISCIII and Fondos FEDER. Declarations of interest: none reported Delirium measured but not excluded at baseline (control group 12 %, intervention group 17%). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation based on use of online calculator (www.randomizer.org) on a 1:1 ratio without restrictions |
Allocation concealment (selection bias) | Unclear risk | No description provided as to how allocations concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were explicitly informed and reminded not to discuss assignment with the assessment staff. Staff providing intervention were unblinded due to the nature of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessment staff were blinded to main study design and group allocation. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Imbalance in discontinuation of intervention with 47% of those dropouts in intervention group due to ‘clinical worsening’ versus 21% in control – unclear if this due to intervention. |
Selective reporting (reporting bias) | Low risk | Study reported in accordance with trial protocol |
Other bias | Low risk | No evidence of other bias |