StrokeNCT00332800
Study Impact of Nutritional Supplementary Treatment of Undernourished Stroke Patient on Functional Outcome Measures
A study testing Nutritional Supplementation in people with Stroke, run by Burke Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stroke
- What is being tested?
- Nutritional Supplementation
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Dec 2005
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemorrhagic and ischemic stroke documented clinically and by neuroimaging.
- Admission to the Stroke Rehabilitation Service of the Burke Rehabilitation Hospital within 4 weeks of the acute neurological insult.
- Informed consent, from patient or other responsible person according to Burke IRB standards.
- Stable medical condition, including cardiac status.
- Patient able to take diet and medication either orally or via the PEG tube.
Who cannot join
- Patients with prior documented history of alcohol abuse, renal and liver diseases, and malabsorption.
- Patients medically unstable.
- Patient's terminal ill (e.g., patients with stroke as a complication of a terminal cancer).
- Patients participating in any other structured therapeutic trial in the acute care hospital or at Burke.
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Rehabilitation Hospital
White Plains, New York, 10605
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Nutritional Supplementation
- Keywords
- Stroke-Nutritional Supplementation-Functional Recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total Functional Independence Measure (TFIM) score, and change in the FIM-cognitive and FIm-motor subscores.
Secondary outcomes (1)
Length of stay (LOS)and discharge disposition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startOct 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single group
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Burke Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Meheroz H Rabadi, MD, MRCPI, Principal investigator, Burke Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332800
- Sponsor's protocol ID
- BRC-343
- Status last verified
- Jun 2005
- First submitted
- 31 May 2006
- Last updated
- 2 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00332800
- Acronym / sponsor ID
- BRC-343
- Conditions
- Stroke
- Keywords
- Stroke-Nutritional Supplementation-Functional Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Burke Rehabilitation HospitalUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Dec 2005
- First posted
- 2 Jun 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemorrhagic and ischemic stroke documented clinically and by neuroimaging.
- Admission to the Stroke Rehabilitation Service of the Burke Rehabilitation Hospital within 4 weeks of the acute neurological insult.
- Informed consent, from patient or other responsible person according to Burke IRB standards.
- Stable medical condition, including cardiac status.
- Patient able to take diet and medication either orally or via the PEG tube.
Key exclusion criteria (4 listed)
- Patients with prior documented history of alcohol abuse, renal and liver diseases, and malabsorption.
- Patients medically unstable.
- Patient's terminal ill (e.g., patients with stroke as a complication of a terminal cancer).
- Patients participating in any other structured therapeutic trial in the acute care hospital or at Burke.
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 |
|---|---|---|
| Nutritional Supplementation | Drug | – |
Primary outcome
Change in total Functional Independence Measure (TFIM) score, and change in the FIM-cognitive and FIm-motor subscores.
1 secondary outcome
Length of stay (LOS)and discharge disposition.
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 2 Jun 2006.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Meheroz H Rabadi, MD, MRCPI principal investigator
Burke Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplementation in people with Stroke, run by Burke Rehabilitation Hospital at 1 site in United States.
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 5 inclusion and 4 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 2 Jun 2006. 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 United States. 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 in total Functional Independence Measure (TFIM) score, and change in the FIM-cognitive and FIm-motor subscores.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2006.