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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:BackgroundA Rehabilitation Program for older adults with hip fracture (HIP-REP) based on Activity of Daily Living has been developed. The objectives of this study were to assess the feasibility and safety of the HIP-REP program to inform a future randomized controlled trial (RCT).MethodsA feasibility study Inspired by the Complex-intervention development (Medical Research Council framework phase II) design using quantitative and qualitative research methods were conducted. Eighteen participants (above 65 years) with hip fracture were recruited from the orthopedic wards. The setting was cross sectoral including Copenhagen University Hospital, Herlev and Gentofte and rehabilitation centers in Herlev, Gentofte and Lyngby-Taarbæk municipalities. A cross-sectoral rehabilitation intervention tailored to the needs of older adults with hip fracture highlighting systematic goal setting and strategies focused on activities of daily living was conducted. Pre-defined feasibility criteria: participants recruitment and retention, duration of measuring the outcome, adherence to intervention, and adverse events, along with self-reported outcomes and an objective measurement of performance in activity of daily living. Focus groups were analyzed using a deductive manifest content analysis approach. Descriptive statistical analysis and paired t-tests were performed for assessing change in outcome measures.ResultsRecruitment rate was 4.5/month. Outcome measures were performed but length and number of questionnaires were a burden. Thirteen out of eighteen participants completed the study three dropped out and two died. Adherence among the 13 was 100%. Focus group revealed issues regarding coordinating the intervention, ensuring procedural processes across sectors regarding recruitment of participants, and documentation in the database. Participants expressed satisfaction with the intervention and felt safe during intervention. Assessment of Motor and Process Skills showed better increase between (range 0.4 to 1.6) in ADL motor ability measures and better increase between (range 0.4 to 0.7) for process ability. No clear association between outcome improvements and intervention adherence.ConclusionsThe cross-sectoral intervention based on daily activities was feasible and safe for older adults with hip fracture. A future RCT, with an improved recruitment strategy and reduced number of outcome measures will evaluate the effectiveness in improving independence and safety performance of activity of daily living.Trial registrationClinicalTrials.gov ID: NCT03828240 . Registered on January 29, 2019.

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.

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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