SarcopeniaPREFISSARCNCT01477086
Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture
An observational study of Sarcopenia and Hip Fracture, run by Hospital Viamed Valvanera, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Hip Fracture, Frailty
- How many people
- 198 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Will be included in the study, prospectively, patients with hip fracture admitted to the Geriatric Rehabilitation Unit, Spain.
Who may be able to join
- 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).
Who cannot join
- Excluding patients will not sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Sarcopenia, Hip Fracture, Frailty
- Keywords
- Sarcopenia, Hip fracture, Frailty
- Medical subject headings
- Sarcopenia, Hip Fractures, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hip fracture | We included patients with traumatic hip fracture, with surgery and who are admitted for rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within the first 72 hours of admission.
Secondary outcomes (5)
Relationship inflammatory indices and sarcopenia.
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.
Measured: A admission and at discharge, after 30 days.
Prevalence of falls.
Will record the number of falls, with and without consequences, in the six months prior to admission.
Measured: During the six months prior to admission.
Acute mortality.
Relation between mortality from any cause and sarcopenia. Correcting the statistical analysis for confounding factors.
Measured: During admission
Relationship sarcopenia and frailty.
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
Measured: At admission and after 30 days.
Relationship sarcopenia and Barthel index.
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).
Measured: At admission and after 30 days .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Viamed Valvanera, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra
- Responsible party
- Sponsor
- Investigators
- Vincenzo Malafarina, MD MSc, Principal investigator, Clinica Los Manzanos, Lardero, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477086
- Sponsor's protocol ID
- Viamed-Sarco-HF
- Acronym
- PREFISSARC
- Status last verified
- Feb 2016
- First submitted
- 19 Oct 2011
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20392703Janssen 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.
PubMed 16420198Fried 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.
PubMed 11253156Perez 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.
PubMed 20694307Herrera 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.
PubMed 16328387Roberts 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.
PubMed 21624928Abizanda 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.
PubMed 21568958Malafarina 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.
PubMed 22153348Malafarina 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.
PubMed 22980996
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Pathophysiology of Sarcopenia in the Elderly Patient With Hip Fracture. Prospective, Observational Study on Consecutive Series
- ClinicalTrials.gov ID
- NCT01477086
- Acronym / sponsor ID
- PREFISSARC / Viamed-Sarco-HF
- Conditions
- Sarcopenia, Hip Fracture, Frailty
- Keywords
- Sarcopenia, Hip fracture, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Hospital Viamed Valvanera, SpainUniversity, hospital or other
- Collaborators
- University of Navarra
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip fracture | – | –We included patients with traumatic hip fracture, with surgery and who are admitted for rehabilitation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Will be included in the study, prospectively, patients with hip fracture admitted to the Geriatric Rehabilitation Unit, Spain.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Excluding patients will not sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
5 secondary outcomes
Relationship inflammatory indices and sarcopenia.
Time frame: A admission and at discharge, after 30 days.
Prevalence of falls.
Time frame: During the six months prior to admission.
Acute mortality.
Time frame: During admission
Relationship sarcopenia and frailty.
Time frame: At admission and after 30 days.
Relationship sarcopenia and Barthel index.
Time frame: At admission and after 30 days .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Background: PubMed 20392703Cruz-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.
- Background: PubMed 16420198Janssen 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.
- Background: PubMed 11253156Fried 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.
- Background: PubMed 20694307Perez 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.
- Background: PubMed 16328387Herrera 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.
- Background: PubMed 21624928Roberts 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.
- Background: PubMed 21568958Abizanda 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.
- Background: PubMed 22153348Malafarina 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.
- Background: PubMed 22980996Malafarina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Malafarina, MD MSc principal investigator
Clinica Los Manzanos, Lardero, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Hip Fracture, run by Hospital Viamed Valvanera, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia prevalence (time frame: Within the first 72 hours of admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477086, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.