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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hospital San Juan de Dios, Spain
Sponsor:
Information provided by (Responsible Party):
Hospital San Juan de Dios, Spain
ClinicalTrials.gov Identifier:
NCT01477086
First received: October 19, 2011
Last updated: January 1, 2013
Last verified: January 2013
  Purpose

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
Sarcopenia
Hip Fracture
Frailty

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital San Juan de Dios, Spain:

Primary Outcome Measures:
  • Sarcopenia prevalence [ Time Frame: Within the first 72 hours of admission. ] [ Designated as safety issue: No ]
    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:
  • Relationship inflammatory indices and sarcopenia. [ Time Frame: A admission and at discharge, after 30 days. ] [ Designated as safety issue: No ]
    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.

  • Prevalence of falls. [ Time Frame: During the six months prior to admission. ] [ Designated as safety issue: No ]
    Will record the number of falls, with and without consequences, in the six months prior to admission.

  • Acute mortality. [ Time Frame: During admission ] [ Designated as safety issue: No ]
    Relation between mortality from any cause and sarcopenia. Correcting the statistical analysis for confounding factors.

  • Relationship sarcopenia and frailty. [ Time Frame: At admission and after 30 days. ] [ Designated as safety issue: No ]
    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

  • Relationship sarcopenia and Barthel index. [ Time Frame: At admission and after 30 days . ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hip fracture
We included patients with traumatic hip fracture, with surgery and who are admitted for rehabilitation

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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, Hospital San Juan de Dios de Pamplona.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477086

Contacts
Contact: Vincenzo Malafarina, MD 0034948231800 vmalafarina@gmail.com

Locations
Spain
Hospital San Juan de Dios Recruiting
Pamplona, Navarra, Spain, 31006
Sub-Investigator: Lucía Gil-Guerrero, Md, PhD         
Sub-Investigator: Francisco Uriz-Otano, MD         
Sub-Investigator: Raquel Iniesta-Benedicto, PhD, MMath         
Principal Investigator: Vincenzo Malafarina, MD         
Sponsors and Collaborators
Hospital San Juan de Dios, Spain
Investigators
Principal Investigator: Vincenzo Malafarina, MD Hospital SAn Juan de Dios, Pamplona, Spain
  More Information

Publications:

Responsible Party: Hospital San Juan de Dios, Spain
ClinicalTrials.gov Identifier: NCT01477086     History of Changes
Other Study ID Numbers: HSJD-Pam-02
Study First Received: October 19, 2011
Last Updated: January 1, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital San Juan de Dios, Spain:
Sarcopenia
Hip fracture
Frailty

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

ClinicalTrials.gov processed this record on July 28, 2014