Effect of Intensive Nutritional Support in Subacute Stroke Patient

NCT04259307 | Completed

• 1 other identifier: 2019-06-109
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Rehabilitation; Nutrition

Outcome Measures

Primary Outcomes (1)

• Korean modified Barthel Index (K-MBI) at 6 months after onset

  Korean modified Barthel Index (0\~100)

  6 months after onset

Study Arms (2)

Intensive nutrition group

EXPERIMENTAL

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

Drug: Omapone Peri 724mL or Winuf Peri 654mL

Control group

NO INTERVENTION

Standard nutritional support only per day for 3 weeks

Interventions

Omapone Peri 724mL or Winuf Peri 654mL DRUG

Additional intravenous nutrition of 500 kcal per day for 3 weeks

Also known as: Comprehensive rehabilitation

Intensive nutrition group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korean Center for Disease Control and Prevention: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Kim DH, Sohn MK, Lee J, Kim DY, Shin YI, Oh GJ, Lee YS, Joo MC, Lee SY, Song MK, Han J, Ahn J, Lee HS, Kim YT, Kim YH, Chang WH. Effect of intensive nutritional support on functional recovery in subacute stroke: A randomized, multicenter, single-blinded trial. Ann Phys Rehabil Med. 2025 May;68(4):101976. doi: 10.1016/j.rehab.2025.101976. Epub 2025 Apr 17.

  PMID: 40250062 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: January 29, 2020
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)