SarcopeniaHIPERPROTNCT01404195
Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia
A study testing Ensure Plus Advance in people with Sarcopenia and Hip Fracture, run by Hospital Viamed Valvanera, Spain at 1 site in Spain.
Trial summary
1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Hip Fracture
- What is being tested?
- Ensure Plus Advance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 65 years or older
- Diagnosis of traumatic hip fracture
- Patients admitted for rehabilitation
- Patients signing informed consent.
Who cannot join
- Stage 4 renal failure
- Child C stage hepatic insufficiency
- Barthel index < 20 in the six months prior to admission
- Dysphagia for liquids
- Active oncological disease who are receiving treatment
- Severe clinical conditions compromising and threatening their lives
Show all 13Show fewer
- Morbid obesity (BMI > 40)
- BMI < 21 kg/m2
- Albumin levels < 2.1 g/dL
- MNA < 11
- Charlson index ≥ 6
- diabetes mellitus
- Patients not doing rehabilitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-protein Nutritional Intervention Based on β-hydroxy-β-methylbutirate, Vitamin D3 and Calcium on Obese and Lean Aged Patients With Hip Fractures and Sarcopenia. The HIPERPROT-GER Study.
- RATIONALE The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. What makes this study different from prior studies is that it will be conducted in a hospital setting, unlike most prior studies, which were conducted in a community setting. The association between muscle mass and strength, inflammatory indices, and functional impairment versus dependence and fragility will also be measured.
- HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for treating sarcopenia in elderly patients with hip fracture and improves functional level.
- OBJECTIVES Primary objective is to assess functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index. Secondary objectives will include: 1) to show the relationship between metabolic and inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased strength; 5) to assess mortality and morbidity.
- EXPECTED RESULTS The investigators expect to find that the supplemented group experiences throughout the study period a significant improvement in functional status (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased strength and a reduction in associated complications (falls) are also expected. The investigators hope to be able to show reductions in inflammatory indices and insulin resistance.
To conclude, by improving muscle strength and mass the investigators expect to find a reduction in the disability and dependence of this population group.
Read the detailed description
INTRODUCTION Sarcopenia is the loss of muscle mass and function associated to age. Rosemberg first spoke of sarcopenia in 1989. A progressive loss of muscle mass occurs from approximately 40 years of age. This loss is estimated at about 8% by decade until the age of 70 years, after which the loss increases to 15% by decade. Healthcare costs attributable to sarcopenia in the United States (US) in 2000 were estimated to be 18.5 billion dollars.
It would be natural to assume a direct relationship between muscle mass and strength, but loss of muscle mass is not the main mechanism for loss of strength.
Proximal femur (hip) fracture is a substantial cause of morbidity and mortality in the elderly. One-year mortality after a hip fracture ranges from 12% and 37%, with an 11% incidence during the first few months.
Twenty-five percent of elderly patients with hip fracture require institutionalization, at least temporary, and only 40% fully recover their pre-fracture functional status.
Nutritional therapy, particularly beta-hydroxy-beta-methylbutyrate (HMB), a metabolite of the essential amino acid, leucine, has aroused great expectations. All prior studies about nutritional supplementation with HMB have shown an improved muscle metabolism, decreased protein degradation, and a significant increase in fat-free mass in both young and elderly people.
- Conditions
- Sarcopenia, Hip Fracture
- Being tested
- Ensure Plus Advance
- Keywords
- Nutritional supplement, CaHMB, Barthel index, 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.
Ensure Plus AdvanceDietary supplement
Participating patients will be dispensed two small bottles daily, one at breakfast and one in the evening, seven days a week
| Study group | Role | What they receive |
|---|---|---|
| Ensure Plus Advance, Supplement | Experimental | Participating patients will be dispensed two bottles daily, one at breakfast and one in the evening, seven days a week. Receives: Dietary Supplement: Ensure Plus Advance |
| Control | No intervention | without supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Barthel index
functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index.
Measured: On admission to hospital and at discharge.
Secondary outcomes (5)
Change from baseline in bioelectrical impedance analysis
Show muscle mass improvement
Measured: On admission to hospital and at discharge.
Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer
Show an increased strength
Measured: On admission to hospital and at discharge.
Death for any cause
assess mortality and morbidity
Measured: During admission
Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedance
To show the relationship between inflammatory indices and sarcopenia
Measured: On admission to hospital and at discharge
Prevalence of sarcopenia
To determine the prevalence of sarcopenia in elderly patients hospitalized for hip fracture.
Measured: hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 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 (25)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Viamed Valvanera, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra
- Responsible party
- Principal investigator, Vincenzo Malafarina, MD MSc, Hospital Viamed Valvanera, Spain
- Investigators
- Vincenzo Malafarina, MD Msc, Principal investigator, Clinica Los Manzanos, Lardero, SpainM Angeles Zulet, PhD, Study chair, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404195
- Sponsor's protocol ID
- HVVV-Log-01
- Other IDs
- HSJDPAM01SARCOP2011, ViamedValvaSarcoHF
- Acronym
- HIPERPROT
- Status last verified
- Feb 2016
- First submitted
- 22 Jul 2011
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janssen I, Heymsfield SB, Wang ZM, Ross R. Skeletal muscle mass and distribution in 468 men and women aged 18-88 yr. J Appl Physiol (1985). 2000 Jul;89(1):81-8. doi: 10.1152/jappl.2000.89.1.81.
PubMed 10904038Cruz-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 20392703Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.
PubMed 9164280Baumgartner RN, Waters DL, Gallagher D, Morley JE, Garry PJ. Predictors of skeletal muscle mass in elderly men and women. Mech Ageing Dev. 1999 Mar 1;107(2):123-36. doi: 10.1016/s0047-6374(98)00130-4.
PubMed 10220041Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
PubMed 12028177Goodpaster BH, Park SW, Harris TB, Kritchevsky SB, Nevitt M, Schwartz AV, Simonsick EM, Tylavsky FA, Visser M, Newman AB. The loss of skeletal muscle strength, mass, and quality in older adults: the health, aging and body composition study. J Gerontol A Biol Sci Med Sci. 2006 Oct;61(10):1059-64. doi: 10.1093/gerona/61.10.1059.
PubMed 17077199Roubenoff R. Sarcopenia and its implications for the elderly. Eur J Clin Nutr. 2000 Jun;54 Suppl 3:S40-7. doi: 10.1038/sj.ejcn.1601024.
PubMed 11041074Evans WJ, Campbell WW. Sarcopenia and age-related changes in body composition and functional capacity. J Nutr. 1993 Feb;123(2 Suppl):465-8. doi: 10.1093/jn/123.suppl_2.465.
PubMed 8429405Visser M, Pahor M, Taaffe DR, Goodpaster BH, Simonsick EM, Newman AB, Nevitt M, Harris TB. Relationship of interleukin-6 and tumor necrosis factor-alpha with muscle mass and muscle strength in elderly men and women: the Health ABC Study. J Gerontol A Biol Sci Med Sci. 2002 May;57(5):M326-32. doi: 10.1093/gerona/57.5.m326.
PubMed 11983728Peake J, Della Gatta P, Cameron-Smith D. Aging and its effects on inflammation in skeletal muscle at rest and following exercise-induced muscle injury. Am J Physiol Regul Integr Comp Physiol. 2010 Jun;298(6):R1485-95. doi: 10.1152/ajpregu.00467.2009. Epub 2010 Apr 14.
PubMed 20393160Paddon-Jones D, Sheffield-Moore M, Urban RJ, Sanford AP, Aarsland A, Wolfe RR, Ferrando AA; New Collective Author. Essential amino acid and carbohydrate supplementation ameliorates muscle protein loss in humans during 28 days bedrest. J Clin Endocrinol Metab. 2004 Sep;89(9):4351-8. doi: 10.1210/jc.2003-032159.
PubMed 15356032Paddon-Jones D, Sheffield-Moore M, Aarsland A, Wolfe RR, Ferrando AA; New Collective Author. Exogenous amino acids stimulate human muscle anabolism without interfering with the response to mixed meal ingestion. Am J Physiol Endocrinol Metab. 2005 Apr;288(4):E761-7. doi: 10.1152/ajpendo.00291.2004. Epub 2004 Nov 30.
PubMed 15572657Jensen GL. Inflammation: roles in aging and sarcopenia. JPEN J Parenter Enteral Nutr. 2008 Nov-Dec;32(6):656-9. doi: 10.1177/0148607108324585.
PubMed 18974248Evans WJ, Morley JE, Argiles J, Bales C, Baracos V, Guttridge D, Jatoi A, Kalantar-Zadeh K, Lochs H, Mantovani G, Marks D, Mitch WE, Muscaritoli M, Najand A, Ponikowski P, Rossi Fanelli F, Schambelan M, Schols A, Schuster M, Thomas D, Wolfe R, Anker SD. Cachexia: a new definition. Clin Nutr. 2008 Dec;27(6):793-9. doi: 10.1016/j.clnu.2008.06.013. Epub 2008 Aug 21.
PubMed 18718696Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.
PubMed 9554417
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
- High-protein Nutritional Intervention Based on β-hydroxy-β-methylbutirate, Vitamin D3 and Calcium on Obese and Lean Aged Patients With Hip Fractures and Sarcopenia. The HIPERPROT-GER Study.
- ClinicalTrials.gov ID
- NCT01404195
- Acronym / sponsor ID
- HIPERPROT / HVVV-Log-01
- Conditions
- Sarcopenia, Hip Fracture
- Keywords
- Nutritional supplement, CaHMB, Barthel index, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 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
- 27 Jul 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.
- RATIONALE The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. What makes this study different from prior studies is that it will be conducted in a hospital setting, unlike most prior studies, which were conducted in a community setting. The association between muscle mass and strength, inflammatory indices, and functional impairment versus dependence and fragility will also be measured.
- HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for treating sarcopenia in elderly patients with hip fracture and improves functional level.
- OBJECTIVES Primary objective is to assess functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index. Secondary objectives will include: 1) to show the relationship between metabolic and inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased strength; 5) to assess mortality and morbidity.
- EXPECTED RESULTS The investigators expect to find that the supplemented group experiences throughout the study period a significant improvement in functional status (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased strength and a reduction in associated complications (falls) are also expected. The investigators hope to be able to show reductions in inflammatory indices and insulin resistance.
To conclude, by improving muscle strength and mass the investigators expect to find a reduction in the disability and dependence of this population group.
Detailed description
INTRODUCTION Sarcopenia is the loss of muscle mass and function associated to age. Rosemberg first spoke of sarcopenia in 1989. A progressive loss of muscle mass occurs from approximately 40 years of age. This loss is estimated at about 8% by decade until the age of 70 years, after which the loss increases to 15% by decade. Healthcare costs attributable to sarcopenia in the United States (US) in 2000 were estimated to be 18.5 billion dollars.
It would be natural to assume a direct relationship between muscle mass and strength, but loss of muscle mass is not the main mechanism for loss of strength.
Proximal femur (hip) fracture is a substantial cause of morbidity and mortality in the elderly. One-year mortality after a hip fracture ranges from 12% and 37%, with an 11% incidence during the first few months.
Twenty-five percent of elderly patients with hip fracture require institutionalization, at least temporary, and only 40% fully recover their pre-fracture functional status.
Nutritional therapy, particularly beta-hydroxy-beta-methylbutyrate (HMB), a metabolite of the essential amino acid, leucine, has aroused great expectations. All prior studies about nutritional supplementation with HMB have shown an improved muscle metabolism, decreased protein degradation, and a significant increase in fat-free mass in both young and elderly people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensure Plus Advance, Supplement | Experimental | Dietary Supplement: Ensure Plus AdvanceParticipating patients will be dispensed two bottles daily, one at breakfast and one in the evening, seven days a week. |
| Control | No intervention | –without supplementation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged 65 years or older
- Diagnosis of traumatic hip fracture
- Patients admitted for rehabilitation
- Patients signing informed consent.
Key exclusion criteria (13 listed)
- Stage 4 renal failure
- Child C stage hepatic insufficiency
- Barthel index < 20 in the six months prior to admission
- Dysphagia for liquids
- Active oncological disease who are receiving treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure Plus AdvanceParticipating patients will be dispensed two small bottles daily, one at breakfast and one in the evening, seven days a week | Dietary supplement | Ensure Plus Advance, Supplement |
Primary outcome
Change from baseline in Barthel index
Time frame: On admission to hospital and at discharge.
functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index.
5 secondary outcomes
Change from baseline in bioelectrical impedance analysis
Time frame: On admission to hospital and at discharge.
Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer
Time frame: On admission to hospital and at discharge.
Death for any cause
Time frame: During admission
Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedance
Time frame: On admission to hospital and at discharge
Prevalence of sarcopenia
Time frame: hospital admission
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 10904038Janssen I, Heymsfield SB, Wang ZM, Ross R. Skeletal muscle mass and distribution in 468 men and women aged 18-88 yr. J Appl Physiol (1985). 2000 Jul;89(1):81-8. doi: 10.1152/jappl.2000.89.1.81.
- 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 9164280Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.
- Background: PubMed 10220041Baumgartner RN, Waters DL, Gallagher D, Morley JE, Garry PJ. Predictors of skeletal muscle mass in elderly men and women. Mech Ageing Dev. 1999 Mar 1;107(2):123-36. doi: 10.1016/s0047-6374(98)00130-4.
- Background: PubMed 12028177Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
- Background: PubMed 17077199Goodpaster BH, Park SW, Harris TB, Kritchevsky SB, Nevitt M, Schwartz AV, Simonsick EM, Tylavsky FA, Visser M, Newman AB. The loss of skeletal muscle strength, mass, and quality in older adults: the health, aging and body composition study. J Gerontol A Biol Sci Med Sci. 2006 Oct;61(10):1059-64. doi: 10.1093/gerona/61.10.1059.
- Background: PubMed 11041074Roubenoff R. Sarcopenia and its implications for the elderly. Eur J Clin Nutr. 2000 Jun;54 Suppl 3:S40-7. doi: 10.1038/sj.ejcn.1601024.
- Background: PubMed 8429405Evans WJ, Campbell WW. Sarcopenia and age-related changes in body composition and functional capacity. J Nutr. 1993 Feb;123(2 Suppl):465-8. doi: 10.1093/jn/123.suppl_2.465.
- Background: PubMed 11983728Visser M, Pahor M, Taaffe DR, Goodpaster BH, Simonsick EM, Newman AB, Nevitt M, Harris TB. Relationship of interleukin-6 and tumor necrosis factor-alpha with muscle mass and muscle strength in elderly men and women: the Health ABC Study. J Gerontol A Biol Sci Med Sci. 2002 May;57(5):M326-32. doi: 10.1093/gerona/57.5.m326.
- Background: PubMed 20393160Peake J, Della Gatta P, Cameron-Smith D. Aging and its effects on inflammation in skeletal muscle at rest and following exercise-induced muscle injury. Am J Physiol Regul Integr Comp Physiol. 2010 Jun;298(6):R1485-95. doi: 10.1152/ajpregu.00467.2009. Epub 2010 Apr 14.
- Background: PubMed 15356032Paddon-Jones D, Sheffield-Moore M, Urban RJ, Sanford AP, Aarsland A, Wolfe RR, Ferrando AA; New Collective Author. Essential amino acid and carbohydrate supplementation ameliorates muscle protein loss in humans during 28 days bedrest. J Clin Endocrinol Metab. 2004 Sep;89(9):4351-8. doi: 10.1210/jc.2003-032159.
- Background: PubMed 15572657Paddon-Jones D, Sheffield-Moore M, Aarsland A, Wolfe RR, Ferrando AA; New Collective Author. Exogenous amino acids stimulate human muscle anabolism without interfering with the response to mixed meal ingestion. Am J Physiol Endocrinol Metab. 2005 Apr;288(4):E761-7. doi: 10.1152/ajpendo.00291.2004. Epub 2004 Nov 30.
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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
M Angeles Zulet, PhD study chair
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Plus Advance in people with 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 4 inclusion and 13 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?
Change from baseline in Barthel index (time frame: On admission to hospital and at discharge.). 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 NCT01404195, which also lists 25 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.