Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis

Hospital Sirio-Libanes

Status: Enrolling

Conditions: Chronic Kidney Diseases

Treatments: Device: Electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03779126

HSL 2017-95

Details and patient eligibility

About

Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. Objective: Assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. The individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.

Full description

Patients in the present study will be submitted to an evaluation protocol that must be started after the consent of the responsible medical team, and the patient through the Informed Consent Term. On the first day, patients will be evaluated for their personal antecedents, life habits, inflammatory and nutritional status, quality of life, Medical Research Council (MRC) and biochemical markers. On the second day, anthropometry, body composition and functional capacity will be performed. On the third day, the muscular function will be assessed by isokinetic evaluation. After completing the evaluations, patients will be allocated into four groups: low frequency (LF), high frequency (HF), low and high frequency (LHF), and sham.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease
• Classical hemodialysis
• Over 18 years old
• No pace maker
• Without cognitive or motor deficit
• No regular physical activity in the last six months

Exclusion criteria

• Abstention for more than two consecutive sessions or four in total
• Inability to perform the tests

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 4 patient groups, including a placebo group

Active comparator

Experimental group

Description:

Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.

Treatment:

Device: Electrical stimulation

Other

Experimental group

Description:

High frequency electrical stimulation for 60 minutes, three times a week during 60 days.

Treatment:

Device: Electrical stimulation

Experimental group

Experimental group

Description:

Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.

Treatment:

Device: Electrical stimulation

Placebo

Placebo Comparator group

Description:

Placebo electrical stimulation for 60 minutes, three times a week during 60 days. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current

Treatment:

Device: Electrical stimulation