Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture (PREFISSARC)
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| First Received Date ICMJE | October 19, 2011 | ||||
| Last Updated Date | January 1, 2013 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01477086 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture | ||||
| Official Title ICMJE | Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture. Prospective, Observational Study on Consecutive Series | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Hip fracture
We included patients with traumatic hip fracture, with surgery and who are admitted for rehabilitation |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Excluding patients will not sign the informed consent. |
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01477086 | ||||
| Other Study ID Numbers ICMJE | HSJD-Pam-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hospital San Juan de Dios, Spain | ||||
| Study Sponsor ICMJE | Hospital San Juan de Dios, Spain | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital San Juan de Dios, Spain | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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