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Chronic Kidney DiseasesNCT03556540

Influence of Exercise in Patients With Chronic Kidney Disease During Hemodialysis

A study testing physical exercise in people with Chronic Kidney Diseases, run by Universidade Metodista de Piracicaba at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
physical exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteBrazil
Study dates
1 Jun 2017to 31 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Will be included in the research patients with chronic kidney disease, aged 40 to 70 years, undergoing hemodialysis

Who cannot join

  • Will be excluded from the research, individuals who are hospitalized 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 .

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Hospital de Clínicas Gaspar Viana

    Belém, Pará, 66087-660

Other trials in Brazil

About this study

Official title: Influence of Exercise in Patients With Chronic Kidney Disease During Hemodialysis on Cardiac Autonomic Modulation, Function e Quality of Life

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.

Read the 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.

Being tested
physical exercise
Keywords
Chronic Kidney Disease, Hemodialysis, Exercise
Medical subject headings
Renal Insufficiency, Chronic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical exerciseOther

    Each participant will perform 30 minutes of aerobic physical activity, using cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis.

Study groups in NCT03556540
Study groupRoleWhat they receive
ControlPlacebo comparatorThe volunteers without performing exercise during hemodialysis. Autonomic heart rate modulation, quality of life, physical fitness and safety level of exercise will be evaluated.
Receives: Other: physical exercise
ExperimentalExperimentalThe volunteers will perform physical exercise during hemodialysis. Autonomic heart rate modulation, quality of life, physical fitness and safety level of exercise will be evaluated.
Receives: Other: physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac autonomic modulation by heart rate variability

    Cardiac Autonomic modulation was avaliated by Heart rate variability with Polar RS800CX

    Measured: Change from baseline heart rate variability at 3 months

  2. Quality of life by Kidney Disease and Quality of Life Short Form 1.3 scale

    Avaliable by Kidney Disease and Quality of Life Short Form 1.3 scale, this scale was divided in 4 domains: Your Health, Kidney Disease, Effects of kidney disease on your daily life and Satisfaction with treatment, each item is put on 0 (worst) to 100 range (better)

    Measured: Change from baseline quality of life at 3 months

  3. Functional capacity by 6-minute walk test

    avaliable by 6-minute walk test

    Measured: Change from baseline 6-minute walk test at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start1 Jun 2017
  3. Primary completion1 Dec 2018
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556540
Sponsor's protocol ID
2.075.500
Status last verified
Aug 2020
First submitted
29 Jun 2017
Last updated
13 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu YM, Chung YC, Chang JS, Yeh ML. Effects of aerobic exercise during hemodialysis on physical functional performance and depression. Biol Res Nurs. 2015 Mar;17(2):214-21. doi: 10.1177/1099800414539548. Epub 2014 Jul 15.

    PubMed 25027035
  • National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.

    PubMed 26498416
  • Martin-Alemany G, Valdez-Ortiz R, Olvera-Soto G, Gomez-Guerrero I, Aguire-Esquivel G, Cantu-Quintanilla G, Lopez-Alvarenga JC, Miranda-Alatriste P, Espinosa-Cuevas A. The effects of resistance exercise and oral nutritional supplementation during hemodialysis on indicators of nutritional status and quality of life. Nephrol Dial Transplant. 2016 Oct;31(10):1712-20. doi: 10.1093/ndt/gfw297. Epub 2016 Aug 10.

    PubMed 27510532
  • Painter P, Carlson L, Carey S, Paul SM, Myll J. Physical functioning and health-related quality-of-life changes with exercise training in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):482-92. doi: 10.1016/s0272-6386(00)70202-2.

    PubMed 10692275

Questions about this trial

What is this clinical trial studying?

A study testing physical exercise in people with Chronic Kidney Diseases, run by Universidade Metodista de Piracicaba at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac autonomic modulation by heart rate variability (time frame: Change from baseline heart rate variability at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03556540, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.

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