Stroke, AcuteNCT06208969
The Effect of Nutrition Counseling on Nutritional Status in Stroke Patients
A study testing intensive nutrition counseling in people with Stroke, Acute and Malnutrition, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Acute, Malnutrition, Old Age; Debility
- What is being tested?
- intensive nutrition counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2021to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intensive and Standard Nutrition Counseling in Monitoring the Nutritional Status of Stroke Patients
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.
Read the detailed 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.
- Conditions
- Stroke, Acute, Malnutrition, Old Age; Debility
- Being tested
- intensive nutrition counseling
- Keywords
- malnutrition, older
- Medical subject headings
- Stroke, Malnutrition, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive nutrition counselingBehavioural
individualized regular nutrition education
| Study group | Role | What they receive |
|---|---|---|
| intensive nutrition counseling | Experimental | Five-stage nutrition counseling vith educational materials was carried out during hospitalization in the intensive nutrition counseling. Telephone interviews were conducted at the 2nd week and 2nd month after discharge. Receives: Behavioral: intensive nutrition counseling |
| standard nutrition counseling | Active comparator | Routine nutritional counseling was applied. Interviewed only at admission and at discharge if patient is consulted. Receives: Behavioral: intensive nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition Risk
Malnutrition risk status according to MUST
Measured: Hospitalization (up to day 5), first month after discharge, third month after discharge
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
Measured: Hospitalization (up to day 5), first month after discharge, third month after discharge
Calf Circumference Measurement
The widest part of the calf was measured from the non-paralyzed side in a sitting position with 90 degrees.
Measured: Hospitalization (up to day 5), first month after discharge, third month after discharge
Malnutrition
Malnutrition diagnosis according to GLIM criteria
Measured: Hospitalization (up to day 5), first month after discharge, third month after discharge
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.
Measured: Hospitalization (up to day 5), first month after discharge, third month after discharge
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)
Measured: Hospitalization (up to day 5), first month after discharge, third month after discharge
Secondary outcomes (2)
Functional Status
Functional status was evaluated according to the Barthel Activities of Daily Living İndex
Measured: last day of hospitalization, first month after discharge, third month after discharge
Disability
Disability was evaluated according to The Modified Rankin Scale
Measured: last day of hospitalization, first month after discharge, third month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start7 Mar 2021
- Primary completion4 May 2022
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Seyidoglu Yuksel, Ege University
- Investigators
- Sevnaz Sahin, Assoc Prof, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208969
- Sponsor's protocol ID
- 20-3.1T/14
- Status last verified
- Jan 2024
- First submitted
- 2 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intensive and Standard Nutrition Counseling in Monitoring the Nutritional Status of Stroke Patients
- ClinicalTrials.gov ID
- NCT06208969
- Acronym / sponsor ID
- 20-3.1T/14
- Conditions
- Stroke, Acute, Malnutrition, Old Age; Debility
- Keywords
- malnutrition, older
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive nutrition counseling | Experimental | Behavioral: intensive nutrition counselingFive-stage nutrition counseling vith educational materials was carried out during hospitalization in the intensive nutrition counseling. Telephone interviews were conducted at the 2nd week and 2nd month after discharge. |
| standard nutrition counseling | Active comparator | Behavioral: intensive nutrition counselingRoutine nutritional counseling was applied. Interviewed only at admission and at discharge if patient is consulted. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive nutrition counselingindividualized regular nutrition education | Behavioural | intensive nutrition counseling, standard nutrition counseling |
Primary outcome
Malnutrition Risk
Time frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Malnutrition risk status according to MUST
BMI
Time frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
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
Calf Circumference Measurement
Time frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
The widest part of the calf was measured from the non-paralyzed side in a sitting position with 90 degrees.
Malnutrition
Time frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Malnutrition diagnosis according to GLIM criteria
Mid Upper Arm Circumference
Time frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Mid upper arm circumference is measured at the midpoint between the acromion and olecranon processes on the shoulder blade and the ulna.
Mid Upper Arm Muscle Area
Time frame: Hospitalization (up to day 5), first month after discharge, third month after discharge
Mid upper arm muscle area is calculated using the standard formula= Mid Upper Arm Circumference-(3.14 x Triceps skinfold thickness)
2 secondary outcomes
Functional Status
Time frame: last day of hospitalization, first month after discharge, third month after discharge
Disability
Time frame: last day of hospitalization, first month after discharge, third month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevnaz Sahin, Assoc Prof study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive nutrition counseling in people with Stroke, Acute and Malnutrition, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malnutrition Risk (time frame: Hospitalization (up to day 5), first month after discharge, third month after discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.