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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01477086
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : February 5, 2016
University of Navarra
Information provided by (Responsible Party):
Hospital Viamed Valvanera, Spain

Brief Summary:

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.

Condition or disease
Sarcopenia Hip Fracture Frailty

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
Actual Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture. Prospective, Observational Study on Consecutive Series
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Acute mortality. [ Time Frame: During admission ]
    Relation between mortality from any cause and sarcopenia. Correcting the statistical analysis for confounding factors.

  4. 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

  5. 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).

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Will be included in the study, prospectively, patients with hip fracture admitted to the Geriatric Rehabilitation Unit, Spain.

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01477086

Hospital Viamed Valvanera
Logroño, La Rioja, Spain, 26005
Sponsors and Collaborators
Hospital Viamed Valvanera, Spain
University of Navarra
Principal Investigator: Vincenzo Malafarina, MD MSc Clinica Los Manzanos, Lardero, Spain


Responsible Party: Hospital Viamed Valvanera, Spain Identifier: NCT01477086     History of Changes
Other Study ID Numbers: Viamed-Sarco-HF
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Keywords provided by Hospital Viamed Valvanera, Spain:
Hip fracture

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms