Nutritional Therapy for Stroke Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Malnutrition Weight Loss Dysphagia |
Procedure: Nutritional support |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Nutritional Therapy for Patients With Acute Stroke and With Poor Nutritional Status or at Risk of Poor Nutritional Status |
- Percentage of patients with weight loss >=5 % at three month follow-up.
- Quality of life, handgrip strength and nutritional status at three months. Dietary intake in hospital. Length of hospital stay.
| Estimated Enrollment: | 125 |
| Study Start Date: | May 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided by Ostfold Hospital Trust
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00163007 History of Changes |
| Other Study ID Numbers: | 297 |
| Study First Received: | September 9, 2005 |
| Last Updated: | May 8, 2009 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Additional relevant MeSH terms:
|
Deglutition Disorders Stroke Cerebral Infarction Weight Loss Malnutrition Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Body Weight Changes Body Weight Signs and Symptoms Nutrition Disorders |
ClinicalTrials.gov processed this record on May 16, 2013