Effect of Intensive Nutritional Support in Subacute Stroke Patient

Not Applicable

Completed

• Conditions: Stroke; Rehabilitation; Nutrition
• Interventions: Drug: Omapone Peri 724mL or Winuf Peri 654mL

• Registration Number: NCT04259307
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-29
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive nutrition group	Omapone Peri 724mL or Winuf Peri 654mL	Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks

Primary Outcome Measures

Name	Time	Method
Korean modified Barthel Index (K-MBI) at 6 months after onset	6 months after onset	Korean modified Barthel Index (0\~100)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of