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NCT Number: NCT05207527

Intradialisis Physical Exercise in Quality of Life and Health

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiovascular exercise

Other

Exercise that mainly stimulates the cardiovascular and respiratory systems.

Other names: No aplicable

Muscle strength

Other

Exercise that primarily stimulates the musculoskeletal system.

Other names: No aplicable

Mixed

Other

Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.

Other names: No aplicable

Primary outcomes

  1. Health indicators - Dialysis efficiency

    Time frame: 6 months

    Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V).

  2. Health indicators - KT/V

    Time frame: 6 months

    It is an indicator of the rate of clearance of urea and other wastes by the dialyzer.

  3. Health indicators - Sarcopenia

    Time frame: 6 months

    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

  4. Kidney Disease and Quality of Life (KDQOL-36)

    Time frame: 6 months

    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

  5. Physical condition - Body composition1

    Time frame: 6 months

    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.

  6. Physical condition - Body composition2

    Time frame: 6 months

    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.

  7. Physical condition - Body composition3

    Time frame: 6 months

    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.

  8. Physical condition - Body composition4

    Time frame: 6 months

    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.

  9. Physical condition - Body composition5

    Time frame: 6 months

    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.

  10. Muscle strength

    Time frame: 6 months

    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

  11. Fatigue

    Time frame: 6 months

    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.

  12. Functional capacity - SPPB

    Time frame: 6 months

    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.

  13. Functional capacity -6MWT

    Time frame: 6 months

    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.

  14. Functional capacity - 2MT

    Time frame: 6 months

    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 outcomes

  1. Depression and anxiety (Beck Scale)

    Time frame: 6 months

    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.

Other outcomes

  1. Caloric intake

    Time frame: 6 months

    Measured by means of the intake diary

  2. Number of participants that Smoke

    Time frame: 6 months

    Assessed by means of surveys. Absence or presence of smoking habit

  3. Prevalence of hemodialysis

    Time frame: 6 months

    Assessed by clinical history.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela García-Laguna, PI

CONTACT

[email protected]

+573213781814

Sponsors and collaborators

Lead sponsor

Universidad del Rosario

Other

Registry information

Official study 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

Acronym: EJERINTRA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2022
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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