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The effect of Electrical Stimulation on muscles in patients with Chronic Kidney Disease

Neuromuscular Electrical Stimulation in patients with Chronic Kidney Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8gj3fkt
Enrollment
Unknown
Registered
2024-04-01
Start date
2022-05-01
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

Renal Insufficiency, Chronic

Interventions

This is an all-controlled, randomized, two-arm study with evaluator blindness. Sixteen participants will be block randomized to either the intervention group or the control group. Intervention group:
E02.331

Sponsors

Universidade Federal do Pará
Lead Sponsor
Fundação Pública Estadual Hospital das Clínicas Gaspar Vianna
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Volunteers diagnosed with Chronic Kidney Disease (CKD); performing hemodialysis on an outpatient basis; age greater than or equal to 18 years; both sexes; level of functioning with a score greater than or equal to 4 on the Johns Hopkins Highest Level of Mobility Scale (ability to transfer from a bed to an armchair); ability to understand study procedures

Exclusion criteria

Exclusion criteria: Volunteers with a pacemaker or implantable cardioverter-defibrillator; neuromuscular diseases; epilepsy; allergic reactions to electrodes; peripheral edema; ischemia in lower extremities; obesity with a body mass index greater than 35; symptomatic ischemic heart disease; history of myocardial ischemia and angina in the last 6 months; significant valvular heart disease or dysrhythmia; unstable medical condition due to acute or chronic illness

Design outcomes

Primary

MeasureTime frame
Outcome found 1. An increase of 0.2 kgf in ankle dorsiflexors, an increase of 1.1 kgf in plantar flexors, a reduction of 0.9 kgf in knee extensors and an increase of 0.9 kgf in knee flexors was observed in the control group during the period of 8 weeks, verified by manual isometric dynaometry between pre and post intervention. In the intervention group, an increase of 0.9 kgf in ankle dorsiflexors, an increase of 0.9 kgf in plantar flexors, a reduction of 1.1 kgf in knee extensors and a reduction of 1.0 kgf in knee flexors were observed in the period of 8 weeks, verified by manual isometric dynaometry between pre and post intervention.;Expected outcome 1. It is expected to find an increase in the peripheral muscle strength of the lower limbs measured through manual isometric dynamometry of the knee extensor and flexor muscles and ankle dorsiflexor and plantar flexor muscles, based on the verification of a variation of at least 1 kilogram-force in the pre and post-intervention measurements.;Expected outcome 4. It is expected to find an increase in the functional capacity measured through the 1-minute sit and stand test, based on the verification of a variation of at least 4 repetitions in the pre and post-intervention measurements.;Outcome found 4. An increase of 1.5 repetitions in the 1-minute sit-to-stand test was observed in the control group, in the 8-week period between pre and post intervention. An increase of 1 in repetitions of the 1-minute sit-to-stand test was observed in the intervention group, in the 8-week period between pre- and post-intervention.

Secondary

MeasureTime frame
Expected outcome 2. It is expected to find improvement in neuromuscular excitability, measured through the chronaxy obtained in the stimulus electrodiagnostic test, from the finding of a chronaxy reduction of at least 100 microseconds in the pre and post-intervention measurements.;Expected outcome 3. It is expected to find an improvement in respiratory muscle strength, measured through manovacuometry, from the observation of an increase of 8% in the predicted values in the pre and post-intervention measurements.;Expected outcome 5. It is expected to find improvement in oxidative stress measured through the malondialdehyde biomarker, based on the observation of a variation of at least 1 Nmol in pre and post-intervention measurements.;Expected outcome 6. It is expected to find improvement in quality of life measured through the physical domain of the World Health Organization Quality of Life Scale (WHOQOL-BREF), from the verification of a variation of at least 2 points in the motor domain in the pre and post-intervention measurements.;Outcome found 2. A reduction in vastus lateralis chronaxis by 92 microseconds and an increase in tibialis anterior chronaxis by 100 microseconds was observed in the control group over a period of 8 weeks, verified by the electrodiagnostic stimulus test between pre and post intervention. An increase in vastus lateralis chronaxis by 42 microseconds and a reduction in tibialis anterior chronaxis by 50 microseconds was observed in the intervention group over a period of 8 weeks, verified by the electrodiagnostic stimulus test between pre and post intervention.;Outcome found 3. In the control group, a 3% increase in the predicted values of maximum inspiratory pressure and a 1% reduction in the predicted values of maximum expiratory pressure were observed in the 8-week period, verified by manovacuometry between pre and post intervention. A 10% increase in the predicted values of maximum inspiratory pressure and a 10% increase in the predi

Countries

Brazil

Contacts

Public ContactClara Almeida

Universidade Federal do Pará

clara.almeida@ics.ufpa.br+55 (91) 8248-9051

Outcome results

None listed

Source: REBEC (via WHO ICTRP)