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Exercise effect using Passive Cycle Ergometry and Electrostimulation Neuromuscular in lower limbs on variables metabolic, respiratory and hemodynamic parameters in neurological patients admitted to an intensive care unit

Effect of an Early Mobilization Program in different protocols on metabolic, hemodynamic, functional and psychological variables in patients hospitalized in an intensive care unit: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-34yvspy
Enrollment
Unknown
Registered
2023-06-03
Start date
2022-02-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

muscle weakness

Interventions

The population will be composed of patients, aged 18 years or older, of both sexes, with a neurocritical profile (due to traumatic brain injury, aneurysms, stroke), admitted to the ICU of the HU-UNIVA
E02.779.474

Sponsors

Universidade de Pernambuco
Lead Sponsor
Universidade de Pernambuco
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients of both sexes; age greater than or equal to 18 years; use of invasive mechanical ventilation for a period of more than 24 hours; which is have functional level I for the mobilization of critically ill patients, as Morris et al. (2008); without use of sedoanalgesia for a period great or equal to 24 hours; variability of less than 20 per cento of the frequency heart rate; systolic blood pressure less than 200 mmHg or greater than 90 mmHg; normal electrocardiogram (no evidence of myocardial infarction) myocardial infarction or arrhythmia); peripheral oxygen saturation greater than 90 per cento; fraction of inspired oxygen less than 60 per cento; without signs of respiratory distress; respiratory rate less than 25ipm; stable hemoglobin more than 7 g/dL; stable platelet count more than 20,000 cells/mm3; leukocyte count of 4,300 - 10,800 cells/mm3; body temperature greater or equal to 38°C; blood glucose levels of 3.5 - 20 mmol/L; clinically stable without the use of vasoactive drugs and/or minimal doses; absence of pain, fatigue and dyspnea; creatine phosphokinase less yhan 400U/L; lactate less than 3mmol/L

Exclusion criteria

Exclusion criteria: suspected and/or confirmation of brain death; in palliative care; patients who present fracture or amputation of lower limbs; pregnant women; presence of cardiac pacemaker or implantable cardioverter-defibrillator; neuromuscular disorders; deep vein thrombosis or pulmonary embolism treated for less than 48 hours; patients who are unable to perform the cycle ergometer or electrical muscle electrostimulation due to the osteomioarticular, dermatological or surgical dysfunctions; Body mass index greater or equal to 35Kg/m2

Design outcomes

Primary

MeasureTime frame
To evaluate the acute effect of passive cycle ergometer and neuromuscular electrostimulation on the level of oxidative stress before and after a session in neurocritical ICU patients. 10ml of venous blood will be collected to be removed from the central venous access of each participant, by a trained professional. The sample will be divided into two tubes (with and without anticoagulant), where they will be centrifuged for 15 minutes at 3000 revolutions per minute (rpm) to obtain the supernatant (serum and plasma) that will be transferred to microtubes for further analysis of the oxidative stress. The oxidative stress marker, malondialdehyde (MDA) will be quantified through the reaction of thiobarbituric acid (TBARS) with the decomposition products of hydroperoxides. For this, 250µl of plasma will be incubated in a water bath at 37° for 60 minutes. Then, the sample will be precipitated with 35% AA perchloric acid and centrifuged at 14000rpm for 20 minutes at 4°C. The supernatant will be transferred to new microtubes where 400µl of 0.6% thiobarbituric acid will be added and incubated at 100°C for 60 minutes. After cooling, the material will be read in an ultraviolet spectrophotometer (Biospectro, model SP-22, Brazil) at a wavelength of 532 nm, at room temperature.The antioxidant activity will be quantified based on the total antioxidant capacity by the DPPH method. The procedure will be based on the method described by Brand-Williams, Cuvelier and Berset (1995) in which an aliquot of 0.006 g of DPPH will be diluted in 50 ml of ethanol, kept under refrigeration and protected from light in an amber glass coated with aluminum foil. . Then, 2 ml of this compound will be added to aluminum foil-lined micro tubes containing 0.05 ml of plasma. Each micro tube will be vortexed for 10 seconds and placed to rest protected from light for a period of 30 minutes. After that, the microtubes will be centrifuged at 10000 rpm at a temperature of 20°C for a period of 15 minutes. The mi

Secondary

MeasureTime frame
To evaluate the acute effect of passive cycle ergometer and neuromuscular electrostimulation on lactate before and after a session in neurocritical ICU patients.The measurement of lactate will be performed by a trained professional, through the collection of 1 to 3 ml of blood collected from the central venous access, with the aid of a heparinized syringe, by a trained professional.At the end of the blood collection, the sample will be inserted into the Radiometer brand ABL80Flex gas analyzer.;To evaluate the acute effect of passive cycle ergometer and neuromuscular electrostimulation on blood glucose before and after a session in neurocritical ICU patients. The analysis of capillary blood glucose will be performed by perforating the patient's digital pulp, after asepsis of the region with 70% alcohol. A lancet and lancing device will be used. From the perforation, a drop of blood will be obtained and inserted into the reactive strips of the Accu-Check Advantage Roche® portable glucometer.;To evaluate and compare the behavior of respiratory variables (compliance and tidal volume) before and after a training session with a passive cycle ergometer and neuromuscular electrostimulation. Respiratory variables (compliance and tidal volume) of critically ill patients will be monitored. For lung compliance assessment, the evaluator will perform an inspiratory pause on the mechanical ventilator and then the compliance value will be recorded on the screen. The analysis of the values corresponding to compliance and tidal volume will be performed by monitoring the screen of the mechanical ventilators that the patient is using, which may be the intermed iX 5 (São Paulo, Brazil), Savina Dragüer (Lübeck, Germany), and SV 300 Mindray.

Countries

Brazil

Contacts

Public ContactThaís Maia

Universidade de Pernambuco

thais.dinizmaia@upe.br+55 (087)38666472

Outcome results

None listed

Source: REBEC (via WHO ICTRP)