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Effectiveness of the computerized balance rehabilitation after hip fracture surgery: A study protocol of a prospective and open-label clinical trial.

ABSTRACT: Although balance problems in older populations are directly correlated with hip fractures, the overall physical gain afforded by balance rehabilitation itself has not yet been fully investigated. Here we describe a protocol for an open-label clinical trial to evaluate the effectiveness of computer-based balance-specific exercise (BSE) on the performance and balance of elderly women who underwent hip fracture surgery (HFS).Elderly female patients (?65 years old) who underwent surgery for femoral neck, intertrochanteric, or subtrochanteric fracture regardless of surgery type will be included. The BSE will be conducted using a computed posturographic system for a 2-week intervention period following HFS. The primary outcome of this study is Berg balance scale score. All functional outcomes will be measured at 1 and 3 weeks and at 3 and 6 months after the surgical intervention. The data will be analyzed using the intention-to-treat principle.

SUBMITTER: Kim IH

PROVIDER: S-EPMC6133532 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Effectiveness of the computerized balance rehabilitation after hip fracture surgery: A study protocol of a prospective and open-label clinical trial.

Kim In-Hee IH Lee Shi-Uk SU Jung Se Hee SH Lee Soong Joon SJ Lee Sang Yoon SY

Medicine 20180901 36

<h4>Introduction</h4>Although balance problems in older populations are directly correlated with hip fractures, the overall physical gain afforded by balance rehabilitation itself has not yet been fully investigated. Here we describe a protocol for an open-label clinical trial to evaluate the effectiveness of computer-based balance-specific exercise (BSE) on the performance and balance of elderly women who underwent hip fracture surgery (HFS).<h4>Methods and analysis</h4>Elderly female patients ...[more]

PMID: 30200127

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Project description:As methicillin-resistant Staphylococcus aureus (MRSA) becomes more prevalent, vancomycin is becoming increasingly used as a prophylaxis against surgical-site infections for cardiothoracic surgeries. However, vancomycin administration can be challenging, and the pharmacokinetics of alternative antibiotics in this setting are poorly understood. The primary objective of this investigation was to describe the pharmacokinetics of daptomycin in patients undergoing coronary artery bypass graft surgery. We enrolled 15 patients undergoing coronary artery bypass surgery requiring cardiopulmonary bypass. Each subject was administered a single open-label dose of daptomycin (8 mg/kg of body weight) for surgical prophylaxis. Fourteen daptomycin plasma samples were collected. Safety outcomes between subjects who received daptomycin and 15 control subjects who received the standard-of-care antibiotic were compared. The mean maximal concentration of daptomycin (C(max)) was 84.4 ± 27.1 ?g/ml; the mean daptomycin concentration during the cardiopulmonary bypass procedure was 33.2 ± 11.4 ?g/ml and was 30.9 ± 12.7 ?g/ml at sternum closure. Mean daptomycin concentrations at 12, 18, 24, and 48 h were 22.7 ± 9.7, 16.2 ± 8.2, 12.0 ± 4.7, and 3.5 ± 2.3 ?g/ml, respectively. Mean daptomycin concentrations were consistently above the MIC at which 90% of the tested isolates are inhibited (MIC??) for S. aureus and S. epidermidis during the cardiopulmonary bypass procedure. Daptomycin was not associated with surgical-site infections or differences in adverse events compared to findings for control subjects. We found that a single dose of daptomycin at 8 mg/kg was well tolerated and achieved adequate plasma concentrations against common pathogens associated with surgical-site infections after cardiothoracic surgery. Daptomycin may be considered an alternative surgical prophylaxis antibiotic for patients undergoing cardiothoracic bypass surgery who are unable to receive vancomycin.

Project description:The aim of this trial was to evaluate the clinical effectiveness and cost-effectiveness of a home-based exercise program delivered four months following hip-fracture surgery. In the two-armed randomized, single blinded clinical trial we included persons who lived in the catchment area, were 70 years or older, and community-dwelling at time of the fracture. We excluded persons who were unable to walk ten meters prior to the fracture, and those who were bedridden or had medical contraindications for exercise at baseline (ie. four months after the fracture). All participants underwent routine treatment and rehabilitation. The intervention group received additional 20 sessions (10 weeks) structured, home exercise targeting gait and balance, delivered by physiotherapists in primary health care. Gait speed was the primary outcome. Secondary outcomes included physical activity, gait characteristics, cognitive function, activities of daily living, health-related quality of life, and health care costs extracted from hospital and municipality records. In total, 223 participants were included. Four months post surgery 143 were randomized for the exercise trial (70% women, mean age 83.4 (SD 6.1) years, mean gait speed 0.6 (SD 0.2) m/sec). Estimated between group difference in gait speed was 0.09 m/sec (95% CI: 0.04 to 0.14, p<0.001) at posttest and 0.07 m/sec (95% CI: 0.02 to 0.12, p = 0.009) 12 months post surgery. The mean between-group QALY difference was -0.009 (95% CI: -0.061 to 0.038). The mean between-group total cost difference was +242.9 EUR (95% CI: -8397 to 8584). Our findings suggest that gait recovery after hip fracture can be improved by introducing a home-based balance and gait exercise program four months post surgery, without increasing total health care costs. Future research should focus on how to implement gait and balance exercise in comprehensive interventions that increase adherence among the most vulnerable persons and have an effect on daily life activities and patient-centred outcomes. Trial registration: ClinicalTrials.gov NCT01379456.

Dataset Information

Effectiveness of the computerized balance rehabilitation after hip fracture surgery: A study protocol of a prospective and open-label clinical trial.

Publications

Effectiveness of the computerized balance rehabilitation after hip fracture surgery: A study protocol of a prospective and open-label clinical trial.

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