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Neuromuscular Electrical Stimulation During Hemodialysis in Peripheral Muscle Strength and Exercise Capacity

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ClinicalTrials.gov Identifier: NCT02786849
Recruitment Status : Unknown
Verified September 2016 by Ana Karla Vieira Brüggemann, University of the State of Santa Catarina.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
Ana Karla Vieira Brüggemann, University of the State of Santa Catarina

Brief Summary:
The objective of this study will be to evaluate the effects of neuromuscular electrical stimulation of high and low frequency and intensity, performed during hemodialysis (HD), on peripheral muscle strength, exercise capacity and muscle change and inflammation markers in patients with chronic kidney disease (CKD).

Condition or disease Intervention/treatment Phase
Kidney Diseases Chronic Kidney Diseases Chronic Kidney Insufficiency Chronic Renal Insufficiency Chronic Renal Diseases Renal Dialysis Hemodialysis Other: neuromuscular electrical stimulation of high frequency and intensity Other: neuromuscular electrical stimulation of low frequency and intensity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Group of high frequency and intensity
Group realized high frequency and intensity neuromuscular electrical stimulation
Other: neuromuscular electrical stimulation of high frequency and intensity

Training with neuromuscular electrical stimulation isometric form in lateral and medial bilaterally vast, three times a week, lasting an hour, the first two hours of dialysis.

Will be applied using portable stimulators with 4 channels. The parameters are: frequency of 50 Hz, pulse width 400ms, rise time and 2s descent, stimulus mode on-off starting with a ratio of 1: 2 in the first week (stimulus time of 10 seconds and rest time of 20s, aiming at adaptation and mitigation of the effects of muscle fatigue), evolving from the second week to a ratio of 1:1 (stimulation time of 10 seconds and rest time of 10s).

The current intensity is adjusted individually for the first application and gradually increased as the tolerance of patients.

In each session there will be a warm-up period, training and slowdown. The intensity will be the maximum tolerated by the patient in order increments every session, this being monitored for further evolutionary calculating.


Experimental: Group of low frequency and intensity
Group realized neuromuscular electrical stimulation of low frequency and intensity
Other: neuromuscular electrical stimulation of low frequency and intensity

Training with neuromuscular electrical stimulation isometric form in lateral and medial bilaterally vast, three times a week, lasting an hour, the first two hours of dialysis.

Will be applied using portable stimulators with 4 channels. The parameters are: 5 Hz frequency, time on: off 1: 3 with a pulse duration of 100ms.

The current intensity is adjusted individually for the first application and it was the least noticeable by the patient.

In each session there will be a warm-up period, training and slowdown.





Primary Outcome Measures :
  1. Peripheral muscle strength [ Time Frame: one month ]
    Increased quadriceps strength evaluated by the Isokinetic Biodex System 4 Pro in isometric mode. The highest peak extensor torque is recorded.

  2. Six-minute walk test [ Time Frame: one month ]
    It will be used to evaluate submaximal exercise capacity and will be held in accordance with the recommendations of the American Thoracic Society (Holland et al, 2014.). The larger distance between the two tests will be used for the analysis, this being compared to pre and after training. The reference values are those described by Britto et al., 2013 and an increase of 25 meters after the training will be considered a clinically important improvement.


Secondary Outcome Measures :
  1. Pulmonary function test [ Time Frame: one month ]
    performed with the portable digital spirometer the following parameters are obtained with the same maneuver: forced vital capacity (FVC) in liter, forced expiratory volume in one second (FEV1) in liter and the FEV1/FVC ratio expressed in absolute terms and in percentage of predicted values normality according to the determined by Pereira et al. (2007).

  2. Quality of life [ Time Frame: one month ]
    It will be measured using the questionnaire Kidney Disease and Quality-of-Life Short Form (KDQOL-SF), the degree of commitment of each domain is measured by values ranging from zero (greater degree of commitment) 100 (no impairment). Thus, the higher the score, the better the quality of life. The questionnaire will be pre to post intervention to see if there were improvements.

  3. Anxiety and Depression [ Time Frame: one month ]
    It used the Hospital Anxiety and Depression Scale - HADS (Hospital Anxiety and Depression Scale). The overall scores for each subscales (anxiety or depression) ranges from 0 to 21, where 0 corresponds to the lowest level of depression or anxiety and 21 at most. At the end, add up the scores of anxiety and depression. The scale is reapplied to the end of the training to compare the scores.

  4. urea clearance [ Time Frame: one month ]
    The result of the urea clearance rate is obtained by multiplying the clearance of the dialyzer (clearance, K, in mL / min) by the planned dialysis time (t in min), and divide the result by the volume of distribution of the patient solute ( volume in ml, for the urea this corresponds to 60% of patient weight).

  5. glomerular filtration rate [ Time Frame: one month ]
    The result of glomerular filtration rate is obtained by NefroCalc calculation system, selecting the CKD-EPI function that is based on the amount of creatinine in mg / dL, age, gender, and individual class, generating the value of the filtration rate glomerular in mL / min / 1.73m2.

  6. pro and anti-inflammatory cytokines [ Time Frame: one month ]
    Both pro and anti-inflammatory cytokines will be analyzed using the plasma of patients with CKD during hemodialysis. Samples of 4 ml of blood will be taken from existing fistulas in patients, there is no need, therefore, no additional invasive procedure for collection. The assessment using the method of enzyme-linked immunosorbent assay (ELISA) using a kit suitable for this purpose.

  7. muscle trophism markers [ Time Frame: one month ]
    The muscle trophism markers will be analyzed using the plasma of patients with CKD during HD. Samples of 4 ml of blood will be taken from existing fistulas in patients, there is no need, therefore, no additional invasive procedure for collection. The assessment of changes in markers related to muscle tropism (mTOR and BDNF - Brain derivated neurotrophic factor) will be evaluated by Western blot.

  8. oxidative stress [ Time Frame: one month ]
    Samples of approximately 200 uL plasma will be reserved for analysis of the total glutathione (GSH) levels. Glutathione is measured by the method Tieze.

  9. markers of muscle damage [ Time Frame: one month ]
    After the coagulated blood samples are centrifuged for serum separation, despising the figurative elements and avoiding hemolysis according to the procedures recommended for biochemical analysis. Dosages of CK and LHD will be carried out with the aid of specific reagent kits for each analysis and quantified by spectrophotometry.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with CKD diagnostic who are on dialysis regularly for at least 6 months, stable and under medical supervision.
  • Patients without uncontrolled hypertension, recent ischemic heart disease (3 months or less), unstable angina and severe cardiac arrhythmias.
  • Patients without diseases that limit the electrical stimulation protocol (respiratory, orthopedic and / or neurological).
  • Patients who do not do any form of physical training or who have been held for more than six months.

Exclusion Criteria:

  • Inability to perform any of the study assessments (lack of understanding or collaboration).
  • Recent decompensation of the clinical picture with or without hospitalization.
  • Presence of chronic obstructive pulmonary disease (COPD or emphysema), musculoskeletal diseases that impede the realization of assessments and training protocol.
  • Uncontrolled hypertension, recent ischemic heart disease (3 months or less), unstable angina and severe cardiac arrhythmias.
  • Abnormal sensitivity in the lower limbs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786849


Locations
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Brazil
Ana Karla Vieira Brüggemann Recruiting
Santo Amaro da Imperatriz, SC - Santa Catarina, Brazil, 88140-000
Contact: Ana Karla Brüggemann, graduation    +554896658289    anakarla_vb@hotmail.com   
Contact: Elaine Paulin, doctor    +554836648602    lainepaulin@gmail.com   
Sponsors and Collaborators
University of the State of Santa Catarina
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ana Karla Vieira Brüggemann, Principal Investigator, University of the State of Santa Catarina
ClinicalTrials.gov Identifier: NCT02786849    
Other Study ID Numbers: U1111-1175-1064
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Ana Karla Vieira Brüggemann, University of the State of Santa Catarina:
Electric Stimulation
Electric Stimulation Therapy
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases