Chronic Kidney Diseases
Conditions
Keywords
Chronic Kidney Disease, Electrical stimulation
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.
Interventions
DEVICEElectrical stimulation
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.
Sponsors
Hospital Sirio-Libanes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The assessments will be conducted for a second investigator to ensure the blinding of first investigator. The subjects will be randomised in four groups (low frequency, high frequency, low and high frequency and sham stimulation) to ensure the blinding of participants.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the improvement of muscle mass | Eight weeks | The muscle mass will be assessed by electric bioimpedance |
| Assess the improvement of muscle strength | Eight weeks | The muscle strength will be assessed using isokinetic by peak torque |
| Assess the improvement of muscle resistance | Eight weeks | The muscle resistance will be assessed using isokinetic by fatigue index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate peripheral muscle function with body composition | Eight weeks | Peripheral muscle function will be assessed by isokinetic dynamometer and body composition will be assessed by bioimpedance (Fresenius) |
| Correlate peripheral muscle function with functional capacity | Eight weeks | Peripheral muscle function will be assessed by isokinetic dynamometer and functional capacity will be assessed by six minute step test. |
| Assess the improvement of intervention in quality of life | Eight weeks | 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. |
| Assess the improvement of intervention in functional capacity | Eight weeks | Functional capacity will be assessed using six minute step test |
| Assess the improvement of intervention in hemodialysis effusion | Eight weeks | The hemodialysis efficacy will be assessed by Kt/v |
| Correlate peripheral muscle function using medical research council score with nutritional status | Eight weeks | 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). |
| Correlate peripheral muscle function using hand grip with nutritional status | Eight weeks | 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). |
Countries
Brazil
Contacts
Primary ContactWellington PS Yamaguti, Phd
Backup ContactIgor G Moraes, Ms
Outcome results
None listed