NCT01477086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

3.9 years

First QC Date

October 19, 2011

Last Update Submit

February 4, 2016

Conditions

Keywords

SarcopeniaHip fractureFrailty

Outcome Measures

Primary Outcomes (1)

  • Sarcopenia prevalence

    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 Outcomes (5)

  • Relationship inflammatory indices and sarcopenia.

    A admission and at discharge, after 30 days.

  • Prevalence of falls.

    During the six months prior to admission.

  • Acute mortality.

    During admission

  • Relationship sarcopenia and frailty.

    At admission and after 30 days.

  • Relationship sarcopenia and Barthel index.

    At admission and after 30 days .

Study Arms (1)

Hip fracture

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • \- Excluding patients will not sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Viamed Valvanera

Logroño, La Rioja, 26005, Spain

Location

Related Publications (9)

  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PMID: 20392703BACKGROUND
  • Janssen I. Influence of sarcopenia on the development of physical disability: the Cardiovascular Health Study. J Am Geriatr Soc. 2006 Jan;54(1):56-62. doi: 10.1111/j.1532-5415.2005.00540.x.

    PMID: 16420198BACKGROUND
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND
  • Perez Durillo FT, Ruiz Lopez MD, Bouzas PR, Martin-Lagos A. [Nutritional status in elderly patients with a hip fracture]. Nutr Hosp. 2010 Jul-Aug;25(4):676-81. Spanish.

    PMID: 20694307BACKGROUND
  • Herrera A, Martinez AA, Ferrandez L, Gil E, Moreno A. Epidemiology of osteoporotic hip fractures in Spain. Int Orthop. 2006 Feb;30(1):11-4. doi: 10.1007/s00264-005-0026-2. Epub 2005 Nov 18.

    PMID: 16328387BACKGROUND
  • Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.

    PMID: 21624928BACKGROUND
  • Abizanda P, Lopez-Jimenez M, Lopez-Torres J, Atienzar-Nunez P, Naranjo JM, McAuley E. Validation of the Spanish version of the Short-Form Late-Life Function and Disability Instrument. J Am Geriatr Soc. 2011 May;59(5):893-9. doi: 10.1111/j.1532-5415.2011.03392.x.

    PMID: 21568958BACKGROUND
  • Malafarina V, Uriz-Otano F, Iniesta R, Gil-Guerrero L. Sarcopenia in the elderly: diagnosis, physiopathology and treatment. Maturitas. 2012 Feb;71(2):109-14. doi: 10.1016/j.maturitas.2011.11.012. Epub 2011 Dec 6.

    PMID: 22153348BACKGROUND
  • Malafarina V, Uriz-Otano F, Iniesta R, Gil-Guerrero L. Effectiveness of nutritional supplementation on muscle mass in treatment of sarcopenia in old age: a systematic review. J Am Med Dir Assoc. 2013 Jan;14(1):10-7. doi: 10.1016/j.jamda.2012.08.001. Epub 2012 Sep 13.

    PMID: 22980996BACKGROUND

MeSH Terms

Conditions

SarcopeniaHip FracturesFrailty

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic Processes

Study Officials

  • Vincenzo Malafarina, MD MSc

    Clinica Los Manzanos, Lardero, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

November 22, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations