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Electrical stimulation in cirrhotic in peripheral muscle strength and exercise capacity

Neuromuscular electrical stimulation in cirrhotic in peripheral muscle strength and exercise capacity: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3sst2s
Enrollment
Unknown
Registered
2017-07-18
Start date
2016-10-20
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

Liver Cirrhosis. Muscle weakness. Reduced exercise capacity

Interventions

Treatment Group: It will consist of 10 participants. These will receive treatment by means of peripheral neuromuscular electrostimulation, 3 times a week, lasting 60 minutes each session. In total the
Device
E02.331.800

Sponsors

Fundação Universidade do Estado de Santa Catarina
Lead Sponsor
Fundação Universidade do Estado de Santa Catarina
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Diagnosis Liver cirrhosis, Child-Pugh B and C; stable and under medical supervision ; patients without : uncontrolled hypertension, recent ischemic heart disease ( 3 months or less ) , unstable angina and severe cardiac arrhythmias ; no evidence of gastrointestinal bleeding , encephalopathy , acute pancreatitis or spontaneous bacterial peritonitis ; patients with absence of respiratory diseases , orthopedic diseases and limiting neurological diseases for electrostimulation and protocol ; patients who do not undertake any form of physical training or who have been held for more than 6 months .

Exclusion criteria

Exclusion criteria: Failure to perform any of the study assessments ( lack of understanding or cooperation ) ; deterioration of the clinical picture during the search ; clinical complications of cardiorespiratory nature and / or musculoskeletal during the survey period; patients with Hepatopulmonary syndrome.

Design outcomes

Primary

MeasureTime frame
Peripheral muscle strength - measured by isokinetic Biodex System in Newtons. For this assessment, the patient will be in the position sent with the member assessment at 60º of knee flexion angulation, maximum voluntary isometric contraction required for 5 seconds with intervals of 60 seconds for rest.;Exercise capacity - measured by the six-minute walk test (Submaximal exercise test). To perform the test follow the criteria standardized by the American Thoracic Society. The patient will be advised to walk the longest possible distance for six minutes, along a 30-meter flat corridor.

Secondary

MeasureTime frame
Peripheral muscle tissue oxygenation - will be performed by means of Near-infrared spectroscopy (NIRS) using the PortaMon device (Artinis Medical Systems,Netherlands). It is a device that uses different wavelengths of the near infrared region to non-invasively measure the values related to oxygenation of the skeletal muscle at rest and / or during exercise as well as its adaptations. This device will be connected to a system (Oxysoft 3.0.89, Artinis Medical Systems®, The Netherlands) throughout the data collection. The variables measured by the NIRS will be: oxyhemoglobin (O2Hb), deoxyhemoglobin (HHb) and total hemoglobin (THb). Tissue saturation index (TSI) is considered an estimate of tissue oxygen saturation (StO2), and is defined as: TSI [%] = O2Hb / THb * 100% = O2Hb / O2Hb + HHb) * 100%.;Physical activity of daily living - will be performed using the triaxial accelerometer (Actigraph GTX3 Pensacola, FL, USA). The Actigraph equipment consists of a small, lightweight device coupled to a strip that will be positioned on the patient's wrist. The equipment has a triaxial accelerometer to collect movement data on three axes: vertical (Y), horizontal right-left (X) and horizontal axis front-back (Z). The counts obtained in a given period of time are linearly related to the intensity of the subject during this period. Patients will be instructed to use the equipment for seven consecutive days for 12 hours per day, so they will be instructed to keep their daily activities completely unchanged while using the device.;Levels of plasma cytokines - (IL-6, IL-10, IL-1ra) - Already reported in the literature, cytokine levels (IL-6, IL-10, IL-1ra) are significantly higher in cirrhotic, stable , Child-Pugh B / C compared to the Child-Pugh A group. However, exercise is also known to induce exponential increase in serum IL-6 levels, which is related to exercise response. Nevertheless, variations in their levels may also be related to the duration and intensity of the exercise.

Countries

Brazil

Contacts

Public ContactCarolina;Elaine de Mello;Ferrazeane

Fundação Universidade do Estado de Santa Catarina;Fundação Universidade do Estado de Santa Catarina

carol_luana@hotmail.com;lainepaulin@gmail.com+55 48 3664 8600;+55 48 3664 8600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)