Effect of Intensive Nutritional Support in Subacute Stroke Patient

Stroke Clinical Trial

Official title:

Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259307
• Other study ID #: 2019-06-109
• Status: Completed
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

• more than 19 years old at stroke onset ? stroke confirmed by brain CT or MRI

• body mass index (BMI) <25 before the comprehensive rehabilitation ? Mini Nutritional Assessment < 12 before the comprehensive rehabilitation ? 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 ? 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) ? Pregnant or lactating women ? Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Related Conditions & MeSH terms

• Nutrition
• Rehabilitation
• Stroke

Intervention

Drug:
• Omapone Peri 724mL or Winuf Peri 654mL
Additional intravenous nutrition of 500 kcal per day for 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Korean modified Barthel Index (K-MBI) at 6 months after onset	Korean modified Barthel Index (0~100)	6 months after onset