Clinical trial NCT03779126: Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
Official title: Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease
Electrical stimulation
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects will be randomised in four groups: 1) low frequency electrical stimulation (LF), 2) high frequency (HF), low and High frequency (LHF), and sham. The subjects will receive electrical stimulation in quadriceps bilaterally for 60 minutes , three times per week, during two months.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the improvement of muscle mass
timeFrame: Eight weeks
measure: Assess the improvement of muscle strength
timeFrame: Eight weeks
measure: Assess the improvement of muscle resistance
timeFrame: Eight weeks
Secondary outcomes:
measure: Assess the improvement of intervention in quality of life
timeFrame: Eight weeks
measure: Correlate peripheral muscle function using medical research council score with nutritional status
timeFrame: Eight weeks
measure: Correlate peripheral muscle function using hand grip with nutritional status
timeFrame: Eight weeks
measure: Correlate peripheral muscle function with body composition
timeFrame: Eight weeks
measure: Correlate peripheral muscle function with functional capacity
timeFrame: Eight weeks
measure: Assess the improvement of intervention in hemodialysis effusion
timeFrame: Eight weeks
measure: Assess the improvement of intervention in functional capacity
timeFrame: Eight weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospitalsiriolibanes
Study officials:
affiliation: Hospital Sírio-Libanês
name: Wellington PS Yamaguti, Phd
role: PRINCIPAL_INVESTIGATOR
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