Comparative Analysis of Sarcopenia in Rehabilitation Outcomes Following Femoral Neck Fracture: a Study in Normal Weight and Obese Study Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Sarcopenia screening using the SARC-F questioner
研究概览
简要总结
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
详细描述
INTRODUCTION
The global population of older adults (aged 65 and above) is on the rise. In 2017, this demographic constituted 13% of the world's population, and projections indicate that by 2050, it is expected to reach 2.1 billion people. A significant aspect of human aging involves the gradual reduction of skeletal muscle mass. Numerous prospective studies indicate that muscle mass tends to decrease by around 6% per decade after reaching mid-life. Sarcopenia was considered to be purely loss of muscle (lean) mass of the extremities. In 2010, the European consensus redefined sarcopenia by incorporating the loss of function, specifically in walking speed or grip strength, along with the loss of muscle mass. Since then, several consensus groups have adopted similar definitions, now characterizing sarcopenia as the combination of both functional decline and loss of muscle mass. Sarcopenia is closely associated with frailty, physical disability, hospitalization, osteoporosis, osteoarthritis, and even mortality. Handgrip strength is a frequently employed method for assessing muscle strength, offering a straightforward, reliable, and cost-effective means to identify elderly adults who may be at risk for disability.
Older adults will represent the 20% of the population by 2030 and half of them will suffer from obesity. The prevalence of obesity has reached 30-40% of the population, and there are expectations for its incidence to continue rising in the coming decades. Obesity is linked to over 200 medical complications and poses an elevated risk of morbidity and mortality. It stands as the fifth leading cause of death globally. Obesity is marked by the excessive accumulation of white adipose tissue, not only within typical fat depots but also ectopically, a phenomenon that notably compromises physical function. The human body undergoes substantial changes in composition as age advances. Notably, muscle and bone mass show a progressive decline from the third decade of life, while fat mass tends to increase until around the age of 70. People who suffer from obesity experience weight gain and loss throughout their lives on the background of different diets, it is important to underline that diet-induced weight loss is associated with not only fat, but also muscle and bone losses and may further exacerbate age-related sarcopenia and frailty in older adults. The decline in muscle mass and strength, known as sarcopenia, is very common among older adults with obesity (sarcopenic obesity) and is closely associated with frailty. Sarcopenic obesity emerges as a significant factor contributing to physical disability.
Sarcopenia shares common physio-pathological mechanisms and is frequently linked with a high prevalence of osteoporosis. The introduction of the osteo-sarcopenia concept reflects the intersection of sarcopenia and osteoporosis, contributing to notable functional consequences, including an elevated risk of falls and hip fractures. Hip fractures have a significant impact on the daily lives of individuals aged 65 and above, as more than 40% of those who experience a hip fracture fail to regain the functional status they had before the fracture. Hip fractures are correlated with a substantial prevalence of institutionalization and mortality, with rates exceeding 35% within three years of the incident. Sarcopenia could potentially contribute to the loss of function in individuals who experience hip fractures. The prevalence of sarcopenia in older individuals admitted to acute units with hip fractures ranges from 17% to 37%. Sarcopenia serves as a significant prognostic factor for mortality among older patients admitted to acute units.
One study assessed the effect of sarcopenic obesity on ability to function in women with subacute hip fracture, and found that the presence of obesity did not worsen the negative prognostic role of sarcopenia in the short-term recovery of ability to function after hip fracture in women .Another study reviewed 222 patients who underwent orthopedic surgery and found higher prevalence of sarcopenia and sarcopenic obesity among these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Sarcopenia screening using the SARC-F questioner
时间窗: From 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.
次要结局
未报告次要终点
研究者
Nechama Monastyrsky
Hospital deputy director
Shmuel Harofeh Hospital, Geriatric Medical Center