Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332800
Status:
COMPLETED
Last Update Posted:
2006-06-02
First Post:
2006-05-31
Brief Title:
Study Impact of Nutritional Supplementary Treatment of Undernourished Stroke Patient on Functional Outcome Measures
Sponsor:
Burke Rehabilitation Hospital
Organization:
Burke Rehabilitation Hospital
Study Overview
Official Title:
What Impact Does Intensive Vs Standard Nutritional Supplementary Treatment of Undernourished Stroke Patient Have on Functional Outcome Measures on an Acute Rehabilitation Unit - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Undernutrition after stroke is frequent and is due to cognitive impairment visuospatial perceptive deficits hemiparesis depression and dysphagia The impact of intensive nutritional supplementation on functional outcome measures in undernourished stroke patient has not been studied
Detailed Description:
The World Health Organization defines malnutrition as the cellular imbalance between supply of nutrients and energy and the bodys demand for them to ensure growth maintenance and specific functions The prevalence of malnutrition in acute stroke patients varies from 8- 34 It has been showed that after an acute stroke malnutrition was present in 163 patients on hospital admission which increased to 264 after one week and 35 after two weeks of hospitalization They also showed that 41 of malnourished stroke patients had poor outcome based on the presence of urinary or respiratory infection pressure sores increased mortality rates greater neurological deficit and longer length of stay compared to 14 of malnourished patients who had a better outcome3 Prevalence studies of malnutrition in stroke patients admitted to an acute rehabilitation hospital has varied from 49 to 60 This high prevalence of undernutrition in post stroke patients is due to inadequate intake poor nutritional status prior to their stroke onset age immobility with increased muscle wasting high level of dependency increased energy demands during the recovery period depression and dysphagia In dysphagic stroke patients this is due to impaired chewing and swallowing from bulbar muscle weakness and decreased sensation during mastication with oral accumulation of solid food resulting in inadequate nutrient intake Cognitive perceptual visual field deficits and motor apraxia all do contribute to impaired self feeding ability and consequently increase the risk for undernutrition in this population
Undernutrition has been identified as the most modifiable factor associated with poor functional outcome and increase length of stay Potter et al in a systematic review of nutritional supplementation in adults suggested that routine nutritional supplementation improved weight and anthropometry both of which are validated measures of nutritional status as well as improved functional outcomes Oral sip feedings has been shown to improve nutritional intake in non-dysphagic patients and improve clinical outcome Potter et al in their trial of 381 poorly nourished patients found that high energy and protein oral supplements administered as a medication pass was associated with significantly better energy intake and weight gain along with a reduction in mortality and an improvement in functional outcome Thus increased energy and protein is justified in acute post stroke nutritionally compromised patients to improve outcome and decrease mortality
Oral nutritional supplements have the advantage of the ease of administration irrespective of oral or enteral feeding route aseptic packaging ensuring patient safety ability to be administered in different consistencies reproducibility due to pre-measured formulas and are established products approved as part of hospital formulary
Undernutrition assessment and treatment after an acute stroke remains a problem in the hospital setting We therefore decided to 1 evaluate what impact aggressive nutritional supplementation in addition to their intake of regular diet has on functional outcome measures and 2 is there an association between dysphagia and nutritional status post-stroke
Undernutrition has been identified as the most modifiable factor associated with poor functional outcome and increase length of stay Potter et al in a systematic review of nutritional supplementation in adults suggested that routine nutritional supplementation improved weight and anthropometry both of which are validated measures of nutritional status as well as improved functional outcomes Oral sip feedings has been shown to improve nutritional intake in non-dysphagic patients and improve clinical outcome Potter et al in their trial of 381 poorly nourished patients found that high energy and protein oral supplements administered as a medication pass was associated with significantly better energy intake and weight gain along with a reduction in mortality and an improvement in functional outcome Thus increased energy and protein is justified in acute post stroke nutritionally compromised patients to improve outcome and decrease mortality
Oral nutritional supplements have the advantage of the ease of administration irrespective of oral or enteral feeding route aseptic packaging ensuring patient safety ability to be administered in different consistencies reproducibility due to pre-measured formulas and are established products approved as part of hospital formulary
Undernutrition assessment and treatment after an acute stroke remains a problem in the hospital setting We therefore decided to 1 evaluate what impact aggressive nutritional supplementation in addition to their intake of regular diet has on functional outcome measures and 2 is there an association between dysphagia and nutritional status post-stroke
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None