Clinical Research Directory

Comparative Analysis of Sarcopenia in Rehabilitation Outcomes Following Femoral Neck Fracture: a Study in Normal Weight and Obese Study Cohort

Sponsor: Shmuel Harofeh Hospital, Geriatric Medical Center

Summary

Impact of Obesity on Sarcopenia Prevalence and Severity in Elderly Adults Recovering from Femoral Neck Fractures: A Prospective Study Introduction Age-related muscle loss, or sarcopenia, which includes reductions in both muscle mass and function, is increasingly recognized as a critical health issue in the elderly. Sarcopenia is associated with frailty, disability, and increased mortality. With its rising prevalence, obesity further complicates aging, leading to a condition termed "sarcopenic obesity" (SO), where sarcopenia coexists with obesity. This combination amplifies risks for physical disability, falls, and fractures in older adults. Although sarcopenia and obesity individually contribute to adverse health outcomes, their combined impact on recovery from hip fractures, particularly femoral neck fractures, is under-researched. Hip fractures severely impact the elderly, with over 40% failing to regain pre-fracture functionality and a mortality rate above 35% within three years post-fracture. This study aims to assess the impact of obesity on sarcopenia prevalence and severity in older adults recovering from femoral neck fractures, addressing an essential gap in understanding SO's role in post-fracture rehabilitation outcomes. Objectives * To evaluate the prevalence and severity of sarcopenia among normal-weight versus obese elderly adults post-femoral neck fracture. * To investigate the association between sarcopenic obesity and functional recovery. * To determine whether obesity modifies sarcopenia's impact on rehabilitation outcomes. Risk-Benefit Statement The study entails minimal risk, as all procedures are non-invasive and consistent with routine rehabilitation practices. The potential benefits include enhanced understanding of sarcopenia's effect on hip fracture recovery, which may inform improved rehabilitation practices. Comprehensive health assessments may also benefit participants' post-fracture care. Study Design Overview This prospective observational study includes hospitalized elderly patients undergoing rehabilitation post-femoral neck fracture. After obtaining informed consent, participants will complete an initial assessment, including demographic information, medical history, cognitive status, and anthropometric measurements. Blood samples will be collected for biochemical markers. Stratification and Assessment: Patients will be categorized into normal-weight and obese groups. Comprehensive assessments, including cognitive function, mobility, frailty, muscle strength, and nutritional status, will establish a baseline for studying sarcopenia and obesity's impact on rehabilitation outcomes. Population and Criteria: Sample Size: Up to 300 participants Inclusion Criteria: * Age 60-85 * Recent femoral neck fracture (within the past year) * Ability to provide informed consent Exclusion Criteria: * Inability to comply with study requirements * History of neurodegenerative or psychiatric conditions, recent major surgeries (excluding femoral neck fracture), or conditions affecting muscle metabolism Procedures: Baseline Evaluation: * Cognitive Function: Mini-Mental State Examination (MMSE) * Anthropometric Measurements: BMI from height and weight * Functional Independence (FIM): Level of independence in daily activities * Mobility (Up \& Go Test): Indicator of balance and mobility * Frailty and Muscle Strength: Handgrip strength, SARC-F questionnaire, Muscle Strength and Reflex Assessment (MSRA) * Nutritional Status: Mini Nutritional Assessment (MNA) * Laboratory Tests: CRP, calcium, vitamin D, CBC Post-Rehabilitation Evaluation: After rehabilitation, participants will repeat baseline assessments to determine changes in sarcopenia severity and functional status. Unscheduled Visits: Participants may request evaluations outside the scheduled timeline, documented by the investigator as necessary. Statistical Analysis * Descriptive Analysis: Mean and standard deviations for continuous data, frequencies for categorical data. * Comparative Analysis: Independent t-tests to compare normal-weight and obese groups, dependent t-tests for within-group changes. * Univariate Analysis: Chi-square or Fisher's exact tests with a significance level of P \< 0.05. Ethics and Confidentiality This study will adhere to the Declaration of Helsinki, ICH-GCP guidelines, and applicable regulations. Informed consent will be obtained from all participants, and confidentiality measures will protect patient privacy, with data limited to authorized personnel and anonymized in reports. Institutional Review Board (IRB) Approval IRB approval will be obtained from the Israeli Ministry of Health, following ICH-GCP guidelines. The IRB will oversee the study protocol, consent forms, and all participant materials. Data Storage and Study Termination Data will be securely stored, with

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