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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06208969
Other study ID # 20-3.1T/14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 7, 2021
Est. completion date November 15, 2023

Study information

Verified date January 2024
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of intensive nutrition counseling on nutritional status and functional recovery in stroke patients over the age of 65, compared to standard nutrition counseling.


Description:

Stroke is the second most common cause of death in the world; It is the third cause of disability that causes serious loss of function and affects patients' daily activities. The rapid aging of society increases the negative impact of stroke on health and limited health resources. 9-35% of patients hospitalized with the diagnosis of acute stroke have malnutrition. However, in the first two weeks after hospitalization, malnutrition rates approximately double within two weeks of hospitalization. Although nutrition is a physiological need, it is also a social activity. Nutritional practices that meet nutritional needs during the disease process may contribute to the functional recovery of patients, the reduction of complications, and survival, as well as contributing to the quality of life of patients, independent of the disease. In terms of malnutrition risk, monitoring and treatment are recommended during the acute and discharge periods. There is a need for studies on the framework and effects of effective nutritional treatment. In order for nutrition treatment practices after discharge to achieve their goals, caregivers need to be trained effectively on this subject. Therefore, the aim of this study is to examine the effects of intensive nutrition counseling to stroke patients over the age of 65 on nutritional and functional status.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date November 15, 2023
Est. primary completion date May 4, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Being admitted to Ege University Faculty of Medicine Hospital Neurology Intensive Care or Clinic with the diagnosis of acute stroke - The patient agrees to participate in the study - Hospital stay for more than 3 days Exclusion Criteria: - Active malignancy, dementia, terminal illness, tetraplegia, severe metabolic disorder - Failure to obtain written consent indicating that they agreed to participate in the study. - The patient did not come for a check-up during the 3-month follow-up period - The patient's stay is longer than 30 days

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
intensive nutrition counseling
individualized regular nutrition education

Locations

Country Name City State
Turkey Ege University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Malnutrition Risk Malnutrition risk status according to MUST Hospitalization (up to day 5), first month after discharge, third month after discharge
Primary BMI Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. If BMI<22 kg/m2, it is considered low Hospitalization (up to day 5), first month after discharge, third month after discharge
Primary Calf Circumference Measurement The widest part of the calf was measured from the non-paralyzed side in a sitting position with 90 degrees. Hospitalization (up to day 5), first month after discharge, third month after discharge
Primary Malnutrition Malnutrition diagnosis according to GLIM criteria Hospitalization (up to day 5), first month after discharge, third month after discharge
Primary Mid Upper Arm Circumference Mid upper arm circumference is measured at the midpoint between the acromion and olecranon processes on the shoulder blade and the ulna. Hospitalization (up to day 5), first month after discharge, third month after discharge
Primary Mid Upper Arm Muscle Area Mid upper arm muscle area is calculated using the standard formula= Mid Upper Arm Circumference-(3.14 x Triceps skinfold thickness) Hospitalization (up to day 5), first month after discharge, third month after discharge
Secondary Functional Status Functional status was evaluated according to the Barthel Activities of Daily Living Index last day of hospitalization, first month after discharge, third month after discharge
Secondary Disability Disability was evaluated according to The Modified Rankin Scale last day of hospitalization, first month after discharge, third month after discharge
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