Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT06705166

Opening soonNot applicableObservational

What this study is about

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…

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age60 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionSarcopenia in Elderly, Sarcopenic Obesity, Frailty, Femoral Fractures

Full registry criteria

Inclusion Criteria: * Age between 60-85 * Suffered a femoral neck fracture in the last year. * Subject willing and able to read, understand and sign an informed consent. Exclusion Criteria: * Inability to comply with the study protocol or understand and sign an informed consent * Diagnosis of a psychiatric disorder prior to the recent femoral neck. * Active malignancy * History of other neurodegenerative diseases including Alzheimer's disease (AD), Parkinson's disease (PD), Lewy Body Dementia (LBD), Frontotemporal dementia (FTD), Multiple sclerosis (MS), Amyotrophic lateral sclerosis (ALS), Creutzfeld Jacob disease (CJD), Multisystem atrophy (MSA), Pseudobulbar palsy (PSP), Corticobasal degeneration (CBD), Wernicke Korsakoff syndrome * Chronic Inflammatory Disorders:(e.g., rheumatoid arthritis, systemic lupus erythematosus). * Endocrine Disorders: Individuals with endocrine disorders affecting muscle metabolism (e.g., Cushing's syndrome, hyperthyroidism) * Recent Major Surgeries: Participants who had undergone major surgeries other than femoral neck fracture within the last six months

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Sarcopenia screening using the SARC-F questionerFrom enrolment to end of the end of rehabilitation, (average 4 weeks)

Sarcopenia screening using the SARC-F questioner among normal-weight versus obese elderly adults post-femoral neck fracture and comparing it to other tests evaluating patients functional status such as the time up and go, Functional Independence Measure and hand grip and their relation to clinical outcomes such as mortality, length of hospitalization and rehabilitation outcomes. SARC-F is a 5 question sarcopenia screening tool with a score range of 0-10 and sores equal or greater than 4 is predictive of sarcopenia.

Study locations

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No public site location was included in this record. Check the original registry for updates.