Clinical trial NCT00332800: Study Impact of Nutritional Supplementary Treatment of Undernourished Stroke Patient on Functional Outcome Measures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke-Nutritional Supplementation-Functional Recovery
Lead sponsor: Burke Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2006-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 body's 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 16.3% patients on hospital admission, which increased to 26.4% 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.

Eligibility criteria: Inclusion Criteria:

1. Hemorrhagic and ischemic stroke documented clinically and by neuroimaging.
2. Admission to the Stroke Rehabilitation Service of the Burke Rehabilitation Hospital within 4 weeks of the acute neurological insult.
3. Informed consent, from patient or other responsible person according to Burke IRB standards.
4. Stable medical condition, including cardiac status.
5. Patient able to take diet and medication either orally or via the PEG tube.

Exclusion Criteria:

1. Patients with prior documented history of alcohol abuse, renal and liver diseases, and malabsorption.
2. Patients medically unstable.
3. Patient's terminal ill (e.g., patients with stroke as a complication of a terminal cancer).
4. Patients participating in any other structured therapeutic trial in the acute care hospital or at Burke.

Primary outcomes:
measure: Change in total Functional Independence Measure (TFIM) score, and change in the FIM-cognitive and FIm-motor subscores.
Secondary outcomes:
measure: Length of stay (LOS)and discharge disposition.
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
Study officials:
affiliation: Burke Rehabilitation Hospital
name: Meheroz H Rabadi, MD, MRCPI
role: PRINCIPAL_INVESTIGATOR
References: