Influence of Nutritional Status on Rehabilitation Outcome in Subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- change in hand grip strenght test score
研究概览
简要总结
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.
详细描述
Stroke is the third leading cause of mortality and the second leading cause of permanent disability in adults, and is therefore very expensive. Some patients with stroke outcomes, regardless of baseline motor and cognitive function, for unknown reasons show an unexpectedly worse outcome than others and this suggests other factors, in addition to the degree of initial disability, that influence the response to rehabilitative treatment.
Nutrition is an essential aspect in the overall picture of the stroke patient. Malnutrition in the hospital setting is an important issue that can negatively influence the rehabilitation outcome (Cederholm et al. 2017; 2019).
Malnutrition is also responsible for the increase in complications, negatively affects the results of treatment, reduces the immune response and predisposes to infections, delays healing, compromises the function of organs and systems, reduces muscle mass and strength, induces psychic effects with depression and low interest in food.
All this leads to a demand for greater and more prolonged care, with a delay in the recovery of the performance (National Guidelines for hospital and care catering. Min. of Health, 2015).
A picture of malnutrition also leads to an alteration of biochemical and haematochemical indexes. Our retrospective pilot study on 30 patients with subacute stroke, showed a positive correlation between the reduction of disability following rehabilitation treatment and the calcium at admission (Siotto et al, 2020). In addition, a recent study with 100 patients admitted to a rehabilitation unit showed that the functional status at the time of admission and the improvement following the rehabilitation program were positively influenced by high blood levels of vitamin D (Lelli et al. 2019).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
change in hand grip strenght test score
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
it is a test to measure the maximum isometric strenght of the hand and forearm muscles
change in Body Mass Index
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
it is a measure of body fat based on height and weight that applies to adult men and women expressed in kg/m²
change in food income detection
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
detection of food intake by measurement of portion of dish assumed from the patients
change in Time Up & Go test (TUG) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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.
change in Neuropathic Pain Four Questions (DN4) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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'.
change in Mini nutritional Assessment (MNA) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
it is a questionnaire that evaluates the nutritional status
change in Barthel index (BI) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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.
change in Modified Ashworth Scale (MAS) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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.
change in glucose serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of glucose in mg/dL
change in magnesium serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of magnesium in mg/dL
change in creatinin serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of creatinin in mg/dL
change in iron serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of iron in microg/dL
change in Motricity Index (MI) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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).
change in Six-Minute Walking Test (6MWT) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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.
change in blood levels of systemic oxidative stress (dROMs)
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
dROMs test measures circulating hydroperoxides (UCarr)
change in antioxydant capacity of serum (BAP)
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
BAP test measures total antioxidant status in serum in micromol/L
change haemoglobin serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of haemoglobin g/dL
change in albumine serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of glucose in g/dL
weight change
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
detection of the weight drop or weight increase
change in Bioimpedance analysis (BIA) measurements
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
it is a non-invasive measurement of body fat, lean muscle mass and hydration
change in Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity portion (FMA-UL) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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)
change in Numerical Rating Scale (NRS) scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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).
change in thiol serum levels (SHp)
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
SHp test measures the circulating thiolic antioxidants in serum in micromol/L
change in triglycerides serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of triglycerides in mg/dL
change in total cholesterol serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of total cholesterol in mg/dL
change in latent iron binding capacity serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of latent iron binding capacity in microg/dL
change in 10 Meter Walk Test scores
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
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.
change in HDL cholesterol serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of HDL cholesterol in mg/dL
change in calcium serum levels
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements of calcium in mg/dL
change in hepatic status serum levels (ALT-GPT)
时间窗: Baseline (T0), Treatment (6 weeks) (T1)
serum measurements o ALT-GPT in U/L
次要结局
未报告次要终点
研究者
Irene Giovanna Aprile
Md, PhD, Principal Investigator, Head of Rehabilitation Unit
Fondazione Don Carlo Gnocchi Onlus
