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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Device: Electrical stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active comparator<br>Low frequency electrical stimulation for 60 minutes, three times a week during 60 days. | Device: Electrical stimulation<br>* 1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.<br>* Other names: sham stimulation;|
| Experimental: Other<br>High frequency electrical stimulation for 60 minutes, three times a week during 60 days. | Device: Electrical stimulation<br>* 1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.<br>* Other names: sham stimulation;|
| Experimental: Experimental group<br>Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days. | Device: Electrical stimulation<br>* 1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.<br>* Other names: sham stimulation;|
| Placebo Comparator: Placebo<br>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 | Device: Electrical stimulation<br>* 1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.<br>* Other names: sham stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the improvement of muscle mass | The muscle mass will be assessed by electric bioimpedance | Eight weeks | 
| Assess the improvement of muscle strength | The muscle strength will be assessed using isokinetic by peak torque | Eight weeks | 
| Assess the improvement of muscle resistance | The muscle resistance will be assessed using isokinetic by fatigue index | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the improvement of intervention in quality of life | The quality of life will be assessed by kidney disease quality of life-short form questionnaire (KDQOL-SF).It is eighty questions about physical aspects, economical and psychological with 80 items. The range could be from 0 to 100. A less score reflect better quality of life. | Eight weeks | 
| Correlate peripheral muscle function using medical research council score with nutritional status | Peripheral muscle strength will be assessed by medical research council score. It is a score which measure the muscle strength in six plans of movement with range 0 to 60. Higher values represent a better outcome. The findings will be correlated with biomarkers (urea, creatinine, ferritin, lactate and insulin growth factor 1). | Eight weeks | 
| Correlate peripheral muscle function using hand grip with nutritional status | Peripheral muscle strength will be assessed by hand grip strength. It is a measure the hand grip strength with range 0 to 120 pounds. Higher values represent a better outcome.The findings will be correlated with biomarkers (urea, creatinine, ferritin, lactate and insulin growth factor 1). | Eight weeks | 
| Correlate peripheral muscle function with body composition | Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius) | Eight weeks | 
| Correlate peripheral muscle function with functional capacity | Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test. | Eight weeks | 
| Assess the improvement of intervention in hemodialysis effusion | The hemodialysis efficacy will be assessed by Kt/v | Eight weeks | 
| Assess the improvement of intervention in functional capacity | Functional capacity will be assessed using six minute step test | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Electrical stimulation