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

NCT06705166 | Not Yet Recruiting

• 1 other identifier: SH-122-24
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Sarcopenia in Elderly; Sarcopenic Obesity; Frailty; Femoral Fractures

Keywords

older adults; sarcopenia; obesity; rehabilitation; femoral fractures

Outcome Measures

Primary Outcomes (1)

• Sarcopenia screening using the SARC-F questioner

  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.

  From enrolment to end of the end of rehabilitation, (average 4 weeks)

Study Arms (2)

Normal weight

Patients 60-85 years old whom Suffered a femoral neck fracture in the last year with normal BMI

Obese

Patients 60-85 years old whom Suffered a femoral neck fracture in the last year with normal BMI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include up to 300 participants, male and female, aged 60 - 85 years, who have been diagnosed with femoral neck fracture and hospitalized for rehabilitation in Shmuel Harofe geriatric hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shmuel Harofeh Hospital, Geriatric Medical Center: lead

MeSH Terms

Conditions

Frailty; Femoral Fractures; Sarcopenia; Obesity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Leg Injuries; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Central Study Contacts

Nechama Monastyrsky, Dr

CONTACT

972-504436226; nechama.monastyrsky@moh.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital deputy director

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 26, 2024
• Study Start: November 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share