Nutritional Status in Subacute Stroke Patients Under Rehabilitation

NCT04923165 | Completed

• 1 other identifier: FDG_Nutristroke_2021
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, is becoming more evident a relationship between malnutrition, stroke-related sarcopenia and/or altered systemic oxidative status in patients with subacute stroke . The aim of this study is the evaluation of nutritional status, the presence of stroke-related sarcopenia and systemic oxidative status in patients with subacute stroke outcomes; another aim is to investigate the correlation of nutritional status, the presence of stroke-related sarcopenia and systemic oxidative status on admission with the rehabilitative outcomes.

Conditions

Stroke

Keywords

Stroke; Nutrition; Rehabilitation; Oxidative stress; Sarcopenia

Outcome Measures

Primary Outcomes (30)

• change in Mini nutritional Assessment (MNA) scores

  it is a questionnaire that evaluates the nutritional status

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Body Mass Index

  it is a measure of body fat based on height and weight that applies to adult men and women expressed in kg/m²

  Baseline (T0), Treatment (6 weeks) (T1)

• weight change

  detection of the weight drop or weight increase

  Baseline (T0), Treatment (6 weeks) (T1)

• change in food income detection

  detection of food intake by measurement of portion of dish assumed from the patients

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Bioimpedance analysis (BIA) measurements

  it is a non-invasive measurement of body fat, lean muscle mass and hydration

  Baseline (T0), Treatment (6 weeks) (T1)

• change in hand grip strenght test score

  it is a test to measure the maximum isometric strenght of the hand and forearm muscles

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Time Up & Go test (TUG) scores

  The Time Up And Go is a test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leant against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible. Time will be measured using a chronometer.

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Barthel index (BI) scores

  The BI is designed to assess the ability of an individual with a neuromuscular or musculoskeletal disorder to care for him/herself. It ranges from 0 to 100, with a higher number meaning better performance in activities of daily living.

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity portion (FMA-UL) scores

  The FMA-UL is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia. The upper limb portion of the FMA-UL ranges from 0 (hemiplegia) to 66 points (normal upper limb motor performance)

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Motricity Index (MI) scores

  The MI aims to evaluate lower limb motor impairment after stroke, administrated on both sides. Items to assess the lower limbs are 3, scoring from 0 to 33 each: (1) ankle dorsiflexion with foot in a plantar flexed position (2) knee extension with the foot unsupported and the knee at 90° (3) hip flexion with the hip at 90° moving the knee as close as possible to the chin. (no movement: 0, palpable flicker but no movement: 9, movement but not against gravity :14, movement against gravity movement against gravity: 19, movement against resistance: 25, normal:33).

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Numerical Rating Scale (NRS) scores

  The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale to rate the pain from 0 (no pain) to 10 (worst pain).

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Neuropathic Pain Four Questions (DN4) scores

  The DN4 used to evaluate presence of neuropathic pain, and consist of a brief interview of four questions answered yes/no: two on what the patient has conceived and two during the exam for the evaluation of hypoesthesia to the touch or sting and the evaluation of allodynia with the skimming of the skin. For each 'yes' a point is assigned. The total score is given by the sum of the individuals. The cut off for the presence of neuropathic pain is '4'.

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Modified Ashworth Scale (MAS) scores

  The MAS is a 6 point ordinal scale used for grading hypertonia in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.

  Baseline (T0), Treatment (6 weeks) (T1)

• change in 10 Meter Walk Test scores

  This test will assess the patient's speed during gait. Patients will be asked to walk at their preferred maximum and safe speed. Patients will be positioned 1 meter before the start line and instructed to walk 10 meters, and pass the end line approximately 1 meter after. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be measured using a stopwatch and recorded to the one hundred of a second (ex: 2.15 s). The test will be recorded 3 times, with adequate rests between them. The average of the 3 times should be recorded.

  Baseline (T0), Treatment (6 weeks) (T1)

• change in Six-Minute Walking Test (6MWT) scores

  The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.

  Baseline (T0), Treatment (6 weeks) (T1)

• change in blood levels of systemic oxidative stress (dROMs)

  dROMs test measures circulating hydroperoxides (UCarr)

  Baseline (T0), Treatment (6 weeks) (T1)

• change in antioxydant capacity of serum (BAP)

  BAP test measures total antioxidant status in serum in micromol/L

  Baseline (T0), Treatment (6 weeks) (T1)

• change in thiol serum levels (SHp)

  SHp test measures the circulating thiolic antioxidants in serum in micromol/L

  Baseline (T0), Treatment (6 weeks) (T1)

• change haemoglobin serum levels

  serum measurements of haemoglobin g/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in glucose serum levels

  serum measurements of glucose in mg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in albumine serum levels

  serum measurements of glucose in g/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in triglycerides serum levels

  serum measurements of triglycerides in mg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in total cholesterol serum levels

  serum measurements of total cholesterol in mg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in HDL cholesterol serum levels

  serum measurements of HDL cholesterol in mg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in calcium serum levels

  serum measurements of calcium in mg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in magnesium serum levels

  serum measurements of magnesium in mg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in creatinin serum levels

  serum measurements of creatinin in mg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in iron serum levels

  serum measurements of iron in microg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in latent iron binding capacity serum levels

  serum measurements of latent iron binding capacity in microg/dL

  Baseline (T0), Treatment (6 weeks) (T1)

• change in hepatic status serum levels (ALT-GPT)

  serum measurements o ALT-GPT in U/L

  Baseline (T0), Treatment (6 weeks) (T1)

Study Arms (1)

patients with stroke

Inpatients and outpatients admitted to the investigators' rehabilitation facility .

Device: robotic assisted intervention; Diagnostic Test: biochemical analyses; Device: BIA, hand grip; Diagnostic Test: nutritional assessment, MNA

Interventions

robotic assisted intervention DEVICE

Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.

patients with stroke

biochemical analyses DIAGNOSTIC_TEST

ematochemical and biochemical serum analyses at T0 and at T1; oxidative stress analyses;

patients with stroke

BIA, hand grip DEVICE

bioimpedentiometric analyses of muscular mass (T0 and T1) , muscular force with hand grip

patients with stroke

nutritional assessment, MNA DIAGNOSTIC_TEST

nutritional status assessment with MNA, body mass index measurements, weight loss detection, food income detection

patients with stroke

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with first ischemic stroke (of ischemic or hemorrhagic aetiology) in subacute phase (within six months after the acute event), hospitalized at the participating intensive-extensive rehabilitation centers will be included.

You may qualify if:

• stroke patients (hemorrhagic or ischemic) documented through Magnetic Resonance Imaging (MRI) or Computed Tomography (CT);
• age between 18 and 85 years;
• latency time within 6 months after the stroke event
• sufficient cognitive and language skills to understand the instructions related to the administration of the assessment scales and to sign informed consent

You may not qualify if:

• 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;
• presence of pacemakers (for interference with bioimpedance measures).

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Don Gnocchi Foundation

Rome, 00168, Italy

Location

Related Publications (11)

• Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.

  PMID: 27642056 BACKGROUND

• Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.

  PMID: 30181091 BACKGROUND

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

  PMID: 20392703 BACKGROUND

• Fulle S, Protasi F, Di Tano G, Pietrangelo T, Beltramin A, Boncompagni S, Vecchiet L, Fano G. The contribution of reactive oxygen species to sarcopenia and muscle ageing. Exp Gerontol. 2004 Jan;39(1):17-24. doi: 10.1016/j.exger.2003.09.012.

  PMID: 14724060 BACKGROUND

• Knops M, Werner CG, Scherbakov N, Fiebach J, Dreier JP, Meisel A, Heuschmann PU, Jungehulsing GJ, von Haehling S, Dirnagl U, Anker SD, Doehner W. Investigation of changes in body composition, metabolic profile and skeletal muscle functional capacity in ischemic stroke patients: the rationale and design of the Body Size in Stroke Study (BoSSS). J Cachexia Sarcopenia Muscle. 2013 Sep;4(3):199-207. doi: 10.1007/s13539-013-0103-0. Epub 2013 Mar 13.

  PMID: 23483531 BACKGROUND

• Lelli D, Perez Bazan LM, Calle Egusquiza A, Onder G, Morandi A, Ortolani E, Mesas Cervilla M, Pedone C, Inzitari M. 25(OH) vitamin D and functional outcomes in older adults admitted to rehabilitation units: the safari study. Osteoporos Int. 2019 Apr;30(4):887-895. doi: 10.1007/s00198-019-04845-7. Epub 2019 Jan 16.

  PMID: 30652217 BACKGROUND

• Scherbakov N, Sandek A, Doehner W. Stroke-related sarcopenia: specific characteristics. J Am Med Dir Assoc. 2015 Apr;16(4):272-6. doi: 10.1016/j.jamda.2014.12.007. Epub 2015 Feb 10.

  PMID: 25676847 BACKGROUND

• Squitti R, Siotto M, Assenza G, Giannantoni NM, Rongioletti M, Zappasodi F, Tecchio F. Prognostic Value of Serum Copper for Post-Stroke Clinical Recovery: A Pilot Study. Front Neurol. 2018 May 30;9:333. doi: 10.3389/fneur.2018.00333. eCollection 2018.

  PMID: 29899723 BACKGROUND

• Matsushita T, Nishioka S, Taguchi S, Yamanouchi A. Sarcopenia as a predictor of activities of daily living capability in stroke patients undergoing rehabilitation. Geriatr Gerontol Int. 2019 Nov;19(11):1124-1128. doi: 10.1111/ggi.13780. Epub 2019 Oct 7.

  PMID: 31591820 BACKGROUND

• Siotto, M., Germanotta, M., Santoro, M., Di Blasi, C., Loreti, C., Mastropaolo, S. & Aprile, I.,Total serum calcium and recovery after rehabilitation in patients with stroke Nov 1 2020, In : Applied Sciences (Switzerland). 10, 21, p. 1-8 8 p., 7893.

  BACKGROUND

• Santoro M, Siotto M, Germanotta M, Bray E, Mastrorosa A, Galli C, Papadopoulou D, Aprile I. BDNF rs6265 Polymorphism and Its Methylation in Patients with Stroke Undergoing Rehabilitation. Int J Mol Sci. 2020 Nov 10;21(22):8438. doi: 10.3390/ijms21228438.

  PMID: 33182716 BACKGROUND

MeSH Terms

Conditions

Stroke; Sarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Irene APRILE, MD,PHD

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD, Principal Investigator, Head of Rehabilitation Unit

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: June 11, 2021
• Study Start: September 4, 2020
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)