Effect of Intensive Nutritional Support in Subacute Stroke Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2023-12-31

Brief Summary

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Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.

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Detailed Description

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Conditions

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Stroke Rehabilitation Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive nutrition group

Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks

Group Type EXPERIMENTAL

Omapone Peri 724mL or Winuf Peri 654mL

Intervention Type DRUG

Additional intravenous nutrition of 500 kcal per day for 3 weeks

Control group

Standard nutritional support only per day for 3 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Omapone Peri 724mL or Winuf Peri 654mL

Additional intravenous nutrition of 500 kcal per day for 3 weeks

Intervention Type DRUG

Other Intervention Names

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Comprehensive rehabilitation

Eligibility Criteria

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Inclusion Criteria

* Acute first-ever stroke patients less than 7 days after onset

* more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI

* body mass index (BMI) \<25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment \< 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment \< 85 at 7 days after stroke onset

Exclusion Criteria

* Transient ischemic stroke

* Progressive or unstable stroke

* Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al.

* Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.)

* A terminal medical diagnosis consistent with survival \< 1 year

* Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No