Clinical trial NCT06096350: Nutritional Status in Subacute Stroke Patients Under Rehabilitation 2.0
Official title: Study of Nutritional Status in Subacute Stroke Patients Under Rehabilitation Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with first ischemic stroke (of ischemic or hemorrhagic etiology) in the subacute phase (within six months after the acute event), hospitalized at the participating intensive-extensive rehabilitation centers will be included.

Brief summary: The Nutristroke study's findings revealed a malnutrition scenario in post-stroke patients undergoing rehabilitation. This has highlighted the significance of a correct nutritional status assessment upon admission to a rehabilitation unit.

The aim of Nutristroke2, therefore, is the assessment of nutritional status, dietary intake, dysphagia, the presence of stroke-related sarcopenia, and systemic oxidative status in patients with subacute stroke outcomes before and after rehabilitation treatment.

A secondary aim is to assess whether there is any correlation between nutritional status, dietary intake, dysphagia, sarcopenia, and systemic oxidative status with rehabilitation outcomes.


Eligibility criteria: Inclusion Criteria:

* stroke patients (hemorrhagic or ischemic) documented through Magnetic Resonance -Imaging (MRI) or Computed Tomography (CT);
* time since stroke event within 6 months
* sufficient cognitive and language skills to understand the instructions related to the administration of the assessment scales and to sign informed consent

Exclusion Criteria:

* presence of a previous stroke based on the medical history;
* behavioral and cognitive disorders that may interfere with the therapeutic activity;
* other orthopedic or neurological complications that may interfere with the rehabilitation protocol;
* inability to understand and sign informed consent;
* the presence of pacemakers (for interference with bioimpedance measures).

Primary outcomes:
measure: change in Mini Nutritional Assessment scores
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in weight in kilograms
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in height in meters
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in value of Body mass Index in kg/(m^2)
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in arm, waist and hips circumferences expressed in cm
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in food intake
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in Bioimpedance analysis (BIA) measurements
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of blood levels of haemoglobin in g/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of blood levels of lymphocite expressed in count of cells or percentage
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of albumine serum levels in g/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of glucose serum levels in mg/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of triglycerides serum levels in mg/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of total cholesterol serum levels in mg/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of HDL cholesterol serum levels in mg/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of calcium serum levels in mg/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in concentration of magnesium serum levels in mg/dL
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in score of Controlling Nutritional Status (CONUT)
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in Geriatric Nutritional Risk Index score
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in hand grip strenght test score
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in Time Up & Go test (TUG) scores
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in Mann Assessment of Swallowing Activity (MASA)
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in Functionl Oral Intake Scale (FOIS) score
timeFrame: baseline (T0), treatment (6 weeks)
measure: change in Barthel index (BI) scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Motricity Index (MI) scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Numerical Rating Scale (NRS) scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Neuropathic Pain Four Questions (DN4) scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Modified Ashworth Scale (MAS) scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in 10 Meter Walk Test scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Six-Minute Walking Test (6MWT) scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Functional Ambulation Classification (FAC) scores
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in three point pinch test
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Changes in the Montreal Cognitive Assessment (MoCA
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Changes in the Symbol Digit Modalities test at follow-up
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: Changes in the kinematic analysis kinetic parameters: Force (N) towards 8 targets
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in serum levels of systemic oxidative stress (dROMs)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in serum antioxydant capacity (BAP)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in serum lipidic peroxidation (LP-Cholox)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in gut microbiote composition
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in sieric I-FABP
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in serum levels of zonuline
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in serum levels of DAO
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in Serum levels of LPS
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in gut metabolomic composition of stool
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in urine levels of indole and scatole
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
measure: change in urine levels of VOCs
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
Secondary outcomes:
measure: assessment of correlation between nutritional status, dysphagia, sarcopenia, oxidative stress with rehabilitation outcome (see primary outcome)
timeFrame: Baseline (T0), Treatment (6 weeks) (T1)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center
state: RM
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: IRENE APRILE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: