Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture (PREFISSARC)

February 4, 2016 updated by: Hospital Viamed Valvanera, Spain

Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture. Prospective, Observational Study on Consecutive Series

Sarcopenia is the loss of muscle mass and function that accompanies aging. The term sarcopenia comes from the Greek "sarx" (flesh) and "penia" (loss).

Sarcopenia is a topic of great interest to geriatricians, and from 2010 discussing the possibility of considering it as a geriatric syndrome.

Diagnostic criteria are reduced muscle mass, reduced strength and impaired physical performance. The presence of muscle mass reduction set presarcopenia diagnosis, when combined with one of the other two are talking about sarcopenia and when are the three is defined as severe sarcopenia.

The hypothesis of our study is that sarcopenia is highly prevalent in older people with hip fracture. The increase in inflammatory indices of older people, along with bed rest, represent factors that accelerate the development of sarcopenia. These factors together could be the base of the high percentage of patients who do not recover the degree of autonomy before the fracture.

Study Overview

Status

Completed

Conditions

Detailed Description

The incidence of hip fracture in Spain is estimated at 551 cases per 100,000 population aged 65 years, with an average cost of treatment for a broken € 9,996.00 and more days of hospitalization than heart attacks. In-hospital mortality is 5.3%. Data from a multicenter study in 77 hospitals of the Spanish territory in 2003 coincide with those of studies conducted in other European countries regarding the incidence, the highest percentage in women and increased exponentially with age.

The fracture of the proximal femur (hip) is a substantial cause of morbidity and mortality in the elderly. Mortality at one year after hip fracture varies between 12 and 37%, with an incidence of 11% during the first months.

25% of elderly patients with hip fracture requires institutionalization, at least temporarily, and only 40% fully recover their functional status before the fracture.

Hip fracture is a major public health problem. It happens more often in the elderly, the average age of patients admitted is 81.4 ± 8.1 years and its incidence has increased significantly in recent years. It causes a high degree of disability, mortality and frequent large economic costs. 50% of patients independent before a hip fracture are unable to recover fully the functionality, face and often the inability to institutionalization.

Only 30-35% of elderly hip fractures regain their previous degree of independence in basic activities of daily living, and only 20-25% do so for instrumental activities.

The investigators hope to find a high prevalence of sarcopenia in patients admitted with hip fracture, and patients with more severe sarcopenia are those having lower functional levels at admission and discharge phenomenon recover. The investigators hope to find a relationship between elevated inflammatory indices and severity of sarcopenia. The investigators hope that the presence of sarcopenia, and its severity, correlates positively with the occurrence of complications during hospitalization.

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • La Rioja
      • Logroño, La Rioja, Spain, 26005
        • Hospital Viamed Valvanera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Will be included in the study, prospectively, patients with hip fracture admitted to the Geriatric Rehabilitation Unit, Spain.

Description

Inclusion Criteria:

  • Age equal to or greater than 65 years;
  • Diagnosis of traumatic fracture of hip;
  • To sign informed consent (patient or legal guardian, if cognitive impairment).

Exclusion Criteria:

- Excluding patients will not sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Hip fracture
We included patients with traumatic hip fracture, with surgery and who are admitted for rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenia prevalence
Time Frame: Within the first 72 hours of admission.
To study the prevalence of sarcopenia in patients with hip fracture, those are hospitalized for rehabilitation. For the diagnosis of sarcopenia will use the criteria of the EWGSOP (1). Will be used bioelectrical impedance (BIA).For the BIA, we use the cut-off proposed by Jansen (2).
Within the first 72 hours of admission.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship inflammatory indices and sarcopenia.
Time Frame: A admission and at discharge, after 30 days.
To demonstrate whether patients with sarcopenia are those with higher levels of inflammatory markers. By measurements of IL-1, IL-6, TNF-alpha and acute phase proteins at admission and at discharge, expected average of 30 days.
A admission and at discharge, after 30 days.
Prevalence of falls.
Time Frame: During the six months prior to admission.
Will record the number of falls, with and without consequences, in the six months prior to admission.
During the six months prior to admission.
Acute mortality.
Time Frame: During admission
Relation between mortality from any cause and sarcopenia. Correcting the statistical analysis for confounding factors.
During admission
Relationship sarcopenia and frailty.
Time Frame: At admission and after 30 days.
Relating the results of bioelectrical impedance and fragility. For the diagnosis of frailty we will refer to the original criteria proposed by L. Fried (3). participants will be followed for the duration of hospital stay, an expected average of 4 weeks
At admission and after 30 days.
Relationship sarcopenia and Barthel index.
Time Frame: At admission and after 30 days .
Demonstrate that patients with sarcopenia are those with more functional limitations after rehabilitation. By contrast to the Barthel index at admission and at discharge, expected average of 30 days of rehabilitation, and the difference between the Barthel Index before fracture and at discharge. The assessment of functional limitation will be performed with the validated Spanish version of the SF-LLDFI (7).
At admission and after 30 days .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Viamed Valvanera, Spain

Collaborators

University of Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 19, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Viamed-Sarco-HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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