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Nutritional Therapy for Stroke Patients

Primary Purpose

Stroke, Malnutrition, Weight Loss

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Nutritional support
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Acute stroke based on clinical symptoms 18 years old and above < 7 days since debut of stroke symptoms and either body mass index (BMI) = or < 20 Weight loss > 5% in 3-6 months or there has been little or is likely to be no or very little nutritional intake for > 5 days Exclusion Criteria: Subarachnoidal bleeding and planned operation Severe dementia Reduced consciousness Immobility Expected short-time survival

Sites / Locations

  • Ostfold Hospital Trust

Outcomes

Primary Outcome Measures

Percentage of patients with weight loss >=5 % at three month follow-up.

Secondary Outcome Measures

Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.

Full Information

First Posted
September 9, 2005
Last Updated
May 8, 2009
Sponsor
Ostfold Hospital Trust
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT00163007
Brief Title
Nutritional Therapy for Stroke Patients
Official Title
Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ostfold Hospital Trust
Collaborators
University of Oslo

4. Oversight

5. Study Description

Brief Summary
Prospective, short-term studies in patients admitted for acute stroke have shown an increased risk of infections, bedsores, impaired functional outcome, slower rate of recovery, poorer rehabilitation potential and higher mortality in patients with a poor nutritional status. In hospitals without routine nutritional assessment and individual nutrition management plans, the risk of patients developing malnutrition may be increased. In this study, patients admitted for acute stroke are randomised into either receiving nutritional therapy derived from estimated individual nutritional intake and nutritional needs, or nutritional therapy based on routine care without routine assessment of nutritional status, intake, or needs. The primary outcome measure is the percentage of patients with weight loss ≥ 5 % at three month follow-up.
Detailed Description
Prospective, short-term studies in patients admitted for acute stroke have shown an increased risk of infections, bedsores, impaired functional outcome, slower rate of recovery, poorer rehabilitation potential and higher mortality in patients with a poor nutritional status. Sixteen percent of stroke patients are already malnourished on admission to hospital. The incidence of dysphagia in patients with acute stroke ranges from 30 to 45%. Dysphagia increases the risk of developing poor nutritional status, and new cases of malnutrition develop during the hospital stay, even during the first week. In hospitals without routine nutritional assessment and individual nutrition management plans, the risk of patients developing malnutrition may be increased. In this study patients admitted for acute stroke are randomised into either receiving nutritional therapy derived from estimated individual nutritional intake and nutritional needs, or nutritional therapy based on routine care; without routine assessment of nutritional status, intake or needs. Nutritional therapy: enriched meals, sip-feedings or enteral feedings. Parameters of nutritional status: Weight, BMI, TSF thickness, mid upper arm circumference, body composition, s-albumin and s-transferrin. Estimation of nutritional intake: Daily registration of food and drink intake. Estimating functional status: Hand grip strength, Barthels ADL index and Scandinavian stroke scale. Estimating quality of life: EQ-5D. Before the inclusion started we decided to use the percentage of patients with weight loss ≥ 5 % at 3 months follow-up as the primary outcome measure because this is correlated better to clinical outcomes as e.g. mortality and comorbidity. Secondary outcome measures were then defined as handgrip strength, quality of life, nutritional status, nutrient intake and length of hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Malnutrition, Weight Loss, Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Nutritional support
Primary Outcome Measure Information:
Title
Percentage of patients with weight loss >=5 % at three month follow-up.
Secondary Outcome Measure Information:
Title
Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute stroke based on clinical symptoms 18 years old and above < 7 days since debut of stroke symptoms and either body mass index (BMI) = or < 20 Weight loss > 5% in 3-6 months or there has been little or is likely to be no or very little nutritional intake for > 5 days Exclusion Criteria: Subarachnoidal bleeding and planned operation Severe dementia Reduced consciousness Immobility Expected short-time survival
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Truls Hauge, PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ostfold Hospital Trust
City
Fredrikstad
ZIP/Postal Code
1603
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20955603
Citation
Ha L, Hauge T, Iversen PO. Body composition in older acute stroke patients after treatment with individualized, nutritional supplementation while in hospital. BMC Geriatr. 2010 Oct 18;10:75. doi: 10.1186/1471-2318-10-75.
Results Reference
derived
PubMed Identifier
20176418
Citation
Ha L, Hauge T, Spenning AB, Iversen PO. Individual, nutritional support prevents undernutrition, increases muscle strength and improves QoL among elderly at nutritional risk hospitalized for acute stroke: a randomized, controlled trial. Clin Nutr. 2010 Oct;29(5):567-73. doi: 10.1016/j.clnu.2010.01.011. Epub 2010 Feb 21.
Results Reference
derived

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Nutritional Therapy for Stroke Patients

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