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Intradialisis Physical Exercise in Quality of Life and Health (EJERINTRA)

Primary Purpose

Chronic Kidney Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cardiovascular exercise
Muscle strength
Mixed
Sponsored by
Universidad del Rosario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Chronic kidney disease, Health indicators, Quality of life, Hemodialysis, Peritoneal dialysis, Cardiovascular exercise, Resistance exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Include participants with stage five of chronic kidney disease,
  • People over 18 years old.
  • Their participation is voluntary and their have signed the informed consent form.
  • Persons that are undergoing hemodialysis for at least 3 months.
  • Persons have ability to do exercise protocols.
  • Persons have the approval by nephrologist doctor and deportologist for to do the study according to the results of initial medical assessment.

Exclusion Criteria:

  • Surgical intervention to least 6 months.
  • Skeletal limitations that affect exercise performance.
  • Psychiatric disorders and psychological such as depression, anxiety that could be affect participation of the study.
  • Body Mass Index greater than 30 kg/m2 and not less than 18.5 kg/m2.
  • Hemodialysis catheter dysfunction or infection as well as participation in home exercise programs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    Cardiovascular exercise

    Muscle strength

    Mixed

    Control

    Arm Description

    Cycloergometer

    Strength exercises will be performed during the hemodialysis session.

    Both aerobic and muscular strength exercises will be performed.

    Conventional treatment or dyalisis usual care

    Outcomes

    Primary Outcome Measures

    Health indicators - Dialysis efficiency
    Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V).
    Health indicators - KT/V
    It is an indicator of the rate of clearance of urea and other wastes by the dialyzer.
    Health indicators - Sarcopenia
    Sarcopenia will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl
    Kidney Disease and Quality of Life (KDQOL-36)
    This will be measured by means of the Kidney Disease and Quality of Life Questionnaire (KDQOL-36) which is defined as a specific questionnaire for patients with kidney disease on dialysis, developed by the Kidney Disease Quality of Life Working Group as a specific self-report measure of health-related quality of life or perceived health in these individuals. It is a self-report questionnaire that combines the generic SF-36 health survey instrument and disease-specific components to assess the health-related quality of life of patients with chronic kidney disease. The minimum value is 0 and the maximum value is 100. A higher score means a better quality of life
    Physical condition - Body composition1
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index, visceral fat percentage, total body fat and muscle percentage.
    Physical condition - Body composition2
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index.
    Physical condition - Body composition3
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of visceral fat percentage.
    Physical condition - Body composition4
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of total body fat.
    Physical condition - Body composition5
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in body muscle percentage.
    Muscle strength
    The muscle strength will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl
    Fatigue
    This variable will be measured by means of the Fatigue Severity Scale created by Krupp for the assessment of fatigue. It consists of 9 items with a Likert-type response with 7 possibilities, of increasing intensity and scoring between 1 and 7, the total is given with the sum of all items. Its objective is to determine the severity of fatigue in patients with renal disease.
    Functional capacity - SPPB
    This variable will be measured by means of a questionnaire called Short Physical Performance Battery. The purpose of this test is to evaluate the functioning of the lower extremities in the elderly and it is applied to older adults who have the ability to transfer from sitting to standing autonomously and without the help of the upper limbs.
    Functional capacity -6MWT
    The functional capacity will also be measured by means of the 6-minute test, which is defined as a constant load stress test that measures the distance a person can walk in a period of six minutes, at a fast pace, on a flat, hard surface.
    Functional capacity - 2MT
    The functional capacity will also be measured by means of the two-minute stationary gait test, which consists of the individuals evaluated marching in place as fast as possible for 2 minutes; reference values have been published for adults between 60 and 94 years of age.

    Secondary Outcome Measures

    Depression and anxiety (Beck Scale)
    This will be measured by means of the Beck Depression and Anxiety Scale. It is a self-assessment scale that primarily assesses the clinical symptoms of melancholy and intrusive thoughts present in depression. It is the one with the highest percentage of cognitive symptoms, highlighting also the absence of motor and anxiety symptoms. It is commonly used to assess the severity of the disease. Scale values range from 0 to 63, a higher score represents a worse outcome.

    Full Information

    First Posted
    September 22, 2021
    Last Updated
    August 3, 2023
    Sponsor
    Universidad del Rosario
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05207527
    Brief Title
    Intradialisis Physical Exercise in Quality of Life and Health
    Acronym
    EJERINTRA
    Official Title
    Design and Effectiveness of Different Physical Exercise-based Interventions About Health Indicators and Quality of Life in Patients With Chronic Kidney Disease in Hemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2024 (Anticipated)
    Primary Completion Date
    February 12, 2028 (Anticipated)
    Study Completion Date
    May 29, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad del Rosario

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing hemodialysis.
    Detailed Description
    Objective of this study will be evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing on hemodialysis. This study will include to 100 people over 18 years old who are stage five of chronic kidney disease and go to hemodialysis units of Bogota D.C, Colombia. The ransomized controlled clinical trial to clusters, with 3 groups of intervetion and 1 control, double masking. All the participants receive information on informed consent. The study was approved by the ethics committee of the Universidad del Rosario

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases
    Keywords
    Chronic kidney disease, Health indicators, Quality of life, Hemodialysis, Peritoneal dialysis, Cardiovascular exercise, Resistance exercise

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    There will be 4 parallel groups, 3 intervention and 1 control group.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    The participants will be randomized; however, since it is an exercise intervention, the participants cannot be masked. When the interpretation of the data is performed, the researcher will not know what type of treatment the person being evaluated is receiving, and the researcher's advisor will make the comparison without knowing what intervention the participant was subjected to.
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardiovascular exercise
    Arm Type
    Experimental
    Arm Description
    Cycloergometer
    Arm Title
    Muscle strength
    Arm Type
    Experimental
    Arm Description
    Strength exercises will be performed during the hemodialysis session.
    Arm Title
    Mixed
    Arm Type
    Experimental
    Arm Description
    Both aerobic and muscular strength exercises will be performed.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Conventional treatment or dyalisis usual care
    Intervention Type
    Other
    Intervention Name(s)
    cardiovascular exercise
    Other Intervention Name(s)
    No aplicable
    Intervention Description
    Exercise that mainly stimulates the cardiovascular and respiratory systems.
    Intervention Type
    Other
    Intervention Name(s)
    Muscle strength
    Other Intervention Name(s)
    No aplicable
    Intervention Description
    Exercise that primarily stimulates the musculoskeletal system.
    Intervention Type
    Other
    Intervention Name(s)
    Mixed
    Other Intervention Name(s)
    No aplicable
    Intervention Description
    Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.
    Primary Outcome Measure Information:
    Title
    Health indicators - Dialysis efficiency
    Description
    Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V).
    Time Frame
    6 months
    Title
    Health indicators - KT/V
    Description
    It is an indicator of the rate of clearance of urea and other wastes by the dialyzer.
    Time Frame
    6 months
    Title
    Health indicators - Sarcopenia
    Description
    Sarcopenia will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl
    Time Frame
    6 months
    Title
    Kidney Disease and Quality of Life (KDQOL-36)
    Description
    This will be measured by means of the Kidney Disease and Quality of Life Questionnaire (KDQOL-36) which is defined as a specific questionnaire for patients with kidney disease on dialysis, developed by the Kidney Disease Quality of Life Working Group as a specific self-report measure of health-related quality of life or perceived health in these individuals. It is a self-report questionnaire that combines the generic SF-36 health survey instrument and disease-specific components to assess the health-related quality of life of patients with chronic kidney disease. The minimum value is 0 and the maximum value is 100. A higher score means a better quality of life
    Time Frame
    6 months
    Title
    Physical condition - Body composition1
    Description
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index, visceral fat percentage, total body fat and muscle percentage.
    Time Frame
    6 months
    Title
    Physical condition - Body composition2
    Description
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index.
    Time Frame
    6 months
    Title
    Physical condition - Body composition3
    Description
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of visceral fat percentage.
    Time Frame
    6 months
    Title
    Physical condition - Body composition4
    Description
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of total body fat.
    Time Frame
    6 months
    Title
    Physical condition - Body composition5
    Description
    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in body muscle percentage.
    Time Frame
    6 months
    Title
    Muscle strength
    Description
    The muscle strength will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl
    Time Frame
    6 months
    Title
    Fatigue
    Description
    This variable will be measured by means of the Fatigue Severity Scale created by Krupp for the assessment of fatigue. It consists of 9 items with a Likert-type response with 7 possibilities, of increasing intensity and scoring between 1 and 7, the total is given with the sum of all items. Its objective is to determine the severity of fatigue in patients with renal disease.
    Time Frame
    6 months
    Title
    Functional capacity - SPPB
    Description
    This variable will be measured by means of a questionnaire called Short Physical Performance Battery. The purpose of this test is to evaluate the functioning of the lower extremities in the elderly and it is applied to older adults who have the ability to transfer from sitting to standing autonomously and without the help of the upper limbs.
    Time Frame
    6 months
    Title
    Functional capacity -6MWT
    Description
    The functional capacity will also be measured by means of the 6-minute test, which is defined as a constant load stress test that measures the distance a person can walk in a period of six minutes, at a fast pace, on a flat, hard surface.
    Time Frame
    6 months
    Title
    Functional capacity - 2MT
    Description
    The functional capacity will also be measured by means of the two-minute stationary gait test, which consists of the individuals evaluated marching in place as fast as possible for 2 minutes; reference values have been published for adults between 60 and 94 years of age.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Depression and anxiety (Beck Scale)
    Description
    This will be measured by means of the Beck Depression and Anxiety Scale. It is a self-assessment scale that primarily assesses the clinical symptoms of melancholy and intrusive thoughts present in depression. It is the one with the highest percentage of cognitive symptoms, highlighting also the absence of motor and anxiety symptoms. It is commonly used to assess the severity of the disease. Scale values range from 0 to 63, a higher score represents a worse outcome.
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Caloric intake
    Description
    Measured by means of the intake diary
    Time Frame
    6 months
    Title
    Number of participants that Smoke
    Description
    Assessed by means of surveys. Absence or presence of smoking habit
    Time Frame
    6 months
    Title
    Prevalence of hemodialysis
    Description
    Assessed by clinical history.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Include participants with stage five of chronic kidney disease, People over 18 years old. Their participation is voluntary and their have signed the informed consent form. Persons that are undergoing hemodialysis for at least 3 months. Persons have ability to do exercise protocols. Persons have the approval by nephrologist doctor and deportologist for to do the study according to the results of initial medical assessment. Exclusion Criteria: Surgical intervention to least 6 months. Skeletal limitations that affect exercise performance. Psychiatric disorders and psychological such as depression, anxiety that could be affect participation of the study. Body Mass Index greater than 30 kg/m2 and not less than 18.5 kg/m2. Hemodialysis catheter dysfunction or infection as well as participation in home exercise programs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriela García-Laguna, PI
    Phone
    +573213781814
    Email
    Dayan.garcia@urosario.edu.co
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diana Ramos-Caballero, CI
    Organizational Affiliation
    Universidad del Rosario
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Fisioterapia durante la hemodiálisis: resultados de un programa de fuerza-resistencia
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    http://www.revistanefrologia.com/es-beneficios-del-ejercicio-fisico-baja-articulo-S0211699515000685
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    Beneficios del ejercicio físico de baja intensidad durante la sesión de hemodiálisis en el paciente anciano
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    Factores no tradicionales influyentes en la calidad de vida de los pacientes de hemodiálisis
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    http://revmovimientocientifico.ibero.edu.co/article/view/mct.14204
    Description
    Ejercicio físico intradiálisis en pacientes con enfermedad renal crónica: características de la carga y beneficios. Una revisión de la literatura.

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