Influence of Exercise in Patients With Chronic Kidney Disease During Hemodialysis
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Introduction: Chronic Renal Failure affects a large part of the world population, being
      characterized by irreversible renal tissue damage, resulting in systemic disturbances that
      negatively affect the patient's life. The most commonly used treatment is hemodialysis, which
      also has certain deleterious effects, so it is necessary to look for therapies that minimize
      these complications. Objective: To analyze the influence of physical exercise during
      hemodialysis on the autonomic heart rate modulation, quality of life and physical functional
      ability in individuals with Chronic Renal Failure at Hospital das Clínicas Gaspar Vianna.
      Method: The intervention consists on performing aerobic exercise during hemodialysis. For the
      evaluation will be applied the KDQOL-SF ™ 1.3 questionnaire, for quality of life; 6-Minute
      Walk Test for physical functional ability; and cardiofrequencimeter for the autonomic heart
      rate modulation. Data will be stored in Microsoft Excel® spreadsheets, it will also be used
      for making graphs and tables. Statistical analysis will be performed in the Bioestat 5.3®
      program and the choice of tests will depend on the distribution and homogeneity of the data.
    

Detailed description: 
      This is a randomized, prospective and quantitative clinical trial, whose patients will be
      selected after analysis of the inclusion and exclusion criteria, which will be performed in
      the Hemodialysis sector of the State Public Foundation Gaspar Vianna Clinical Hospital.

      The target population of this study will consist of individuals with chronic renal failure
      undergoing hemodialysis. The volunteers of the study will be randomly randomized by a blind
      researcher who does not know the protocol, groups or volunteers that will be inserted in the
      study, being allocated in Control Group and Experimental Group.

      The sample calculation was performed using the GraphPad StatMate application, version 1.01,
      with a significance of 5% and a test power of 80%, being used as reference the number of
      cases found in the literature, being determined that 20 volunteers will be included in the
      study With chronic kidney disease and who undergo hemodialysis treatment.

      In the study, individuals who attend the Monteiro Leite Hemodialysis Center, aged 40 to 70
      years, undergoing hemodialysis, only in the FPEHCGV, 3 times a week with a minimum of 6
      months of hemodialysis.

      Will be excluded from the research, individuals who are hospitalized at the Gaspar Vianna
      Clinic Hospital or that during the application of the protocol are hospitalized, have
      osteomioarticular diseases that prevent the proposed exercise, patients who use drugs that
      influence the heart rhythm , Patients with values of less than 24 points in the evaluation of
      the mini state of mental assessment, patients with a pacemaker installed, patients who
      underwent previous cardiac surgery less than six months, patients with a body mass index
      greater than 30 / kg / m2 .

      For the data collection will be used: Polarimeter of the brand POLAR®, model RS800CX (Polar
      Electro TM, Kempele, Finland); Premium® Aneroid Sphygmomanometer and Premium® Brand
      Stethoscope, Rappaport Model (Wenzhou Instruments Co; China); Nonin Pulse Oximeter, KDQOL -
      SF ™ 1.3 Scale and Modified Borg Scale (CR10). Samples will be collected in the control and
      experimental groups before the start of the protocol, 1 month after protocol initiation, at
      the end of the protocol and 1 month after the end of the protocol.

      For the evaluation of the autonomic modulation of the HR will be used the analysis of the
      variability of the same, at the moment of the evaluation, after one month of intervention, in
      the second month and at the end of the collection. The collections will be performed between
      8:00 a.m. to 12:00 p.m. and 3:00 p.m. to 7:00 p.m., in order to minimize influences of the
      circadian cycle on the variability of the HR.

      During the evaluation, respiratory rate and blood pressure will be monitored in order to
      discard their influence on heart rate variability.

      At collection, the patients will be positioned first in prone and then supine and finally in
      standing position. For each analysis, they will be kept in rest for 10 minutes - at each
      position - allowing the stabilization of vital signs. Next, the HR and the iR-R will be
      recorded, with a duration of 10 minutes, and the patient will be advised not to perform
      movements and not to talk during the collection period.

      The recording of HRV will be performed by means of a POLAR® brand, RS800CX (Polar Electro ™,
      Kempele, Finland) cardiofrequency meter, where the HR signal will be captured by a tape with
      the signal receiver, placed in the thorax of the Patient at the time of the xiphoid process
      of the sternum.

      The transfer of the data recorded by the frequencymeter will be evaluated for the Polar
      ProTrainer Software (Polar Electro OY, Kempele, Finland) through an infrared signal emitting
      interface, where it will be stored and subsequently exported in .txt format so that later ,
      Is analyzed in the program Kubios HRV 2.2 (MATLAB, Kuopio, Finland) and saved in the computer
      with the collection time.

      For the analysis, there will be a selection of a five-minute stretch containing the highest
      signal stability, discarding the initial 30 seconds and the final 30 seconds of collection,
      provided that it comprises at least 5 minutes or 256 points.

      The analysis of the variables in the time domain will be: square root of the square mean of
      the differences between adjacent normal RR intervals (rMSSD), standard deviation of all
      normal RR intervals recorded in a time interval (SDNN), and variables in the domain of the
      Frequency: low frequency spectral component (BF), high frequency spectral component (AF), BF
      / AF ratio and nonlinear variables: Poincaré plot width (SD1), and Shannon entropy.

      It will be evaluated by the 6-Minute Walk Test. It is performed from the placement of 2
      cones, one at each end of a 30-meter course. The maximum distance covered by the patient is
      evaluated in 6 minutes, with walking rhythm respecting its limits, and can not run.

      Heart and respiratory rate, blood pressure, shortness of breath, fatigue in the legs from the
      Borg scale, and blood oxygenation should be checked before and after the test. The following
      variables were evaluated: heart rate, O2 saturation and Borg scale in the third minute of the
      test.

      For the evaluation of the quality of life, the KDQOL - SF ™ 1.3 Questionnaire will be used,
      which is an instrument of easy administration and comprehension that has already been
      validated in Brazil. Its application will take place as follows: the questionnaire will be
      delivered to the participant and the doubts will be solved, thus enabling the individual to
      fill out the instrument properly. If the individual is not literate, the evaluators will only
      assist in reading the questionnaire and answering questions.

      The level of safety will be evaluated by constant monitoring of cardiorespiratory variables,
      such as heart rate, oxygen pulse saturation, respiratory rate and blood pressure, which will
      be verified and monitored throughout the duration of the technique.

      The determination of the protocol was based on a previous study carried out. After
      randomization of the groups the volunteers of the experimental group will carry out a
      proposed protocol.

      Each participant will perform 30 minutes of aerobic physical activity, using cycle ergometer
      (Physycal, Londrina, Brazil). The exercise will begin 30 minutes after the start of
      hemodialysis, and will be performed three times a week for three months.

      Before starting the session, a sphygmomanometer, an oximeter and a heart rate monitor will be
      placed during the procedure. By control, blood pressure, heart rate, peripheral saturation
      and the Borg Scale will be evaluated every 5 minutes. The heart rate variability will be
      evaluated every day between the hours of 8:00 a.m. to 12:00 a.m., in rest of 10 minutes in
      the positions of dorsal decubitus, sedestation and standing.

      The sessions will be divided into 3 phases: heating, conditioning and cooling. In the warm-up
      phase 5 minutes of exercise will be performed between 60-70% of maximal heart rate, with Borg
      (modified) between 1 and 2. In the conditioning phase, 20 minutes of moderate exercise will
      be performed, with HR between 70-80% And Borg (modified) between 3 and 4. And the quench
      phase will be 5 min, with FC between 60-70% of the maximum and Borg (modified) between 1 and
      2. The maintenance of the parameters will be regulated by the speed of realization of the
      exercise.

      Exercise will be discontinued if the participant has a systolic pressure above 180mmHg, a
      diastolic pressure above 95mmHg, a 20% change in heart rate, a saturation of less than 88%,
      physical exhaustion, chest pain, dyspnoea, dizziness and fatigue of the exercised limbs.
    

Intervention name(s): physical exercise
Intervention type(s): Other
Intervention description(s): Each participant will perform 30 minutes of aerobic physical activity, using cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each participant will perform 30 minutes of aerobic on cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis performed three times a week for three months.
The sessions will be divided into heating, conditioning and cooling. In the warm-up phase 5 minutes of exercise will be performed between 60-70% of maximal heart rate, with Borg between 1 and 2. In the conditioning phase, 20 minutes of moderate exercise will be performed, with HR between 70-80% And Borg (modified) between 3 and 4. And the quench phase will be 5 min, with FC between 60-70% of the maximum and Borg (modified) between 1 and 2.
Exercise will be discontinued if the participant has a systolic pressure above 180mmHg, a diastolic pressure above 95mmHg, a 20% change in heart rate, a saturation of less than 88%, physical exhaustion, chest pain, dyspnoea, dizziness and fatigue of the exercised limbs .
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Chronic Kidney Disease; Hemodialysis; Exercise