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

August 3, 2023 updated by: Universidad del Rosario

Design and Effectiveness of Different Physical Exercise-based Interventions About Health Indicators and Quality of Life in Patients With Chronic Kidney Disease in Hemodialysis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiovascular exercise
Cycloergometer
Other: cardiovascular exercise
Exercise that mainly stimulates the cardiovascular and respiratory systems.
Other Names:
  • No aplicable
Experimental: Muscle strength
Strength exercises will be performed during the hemodialysis session.
Other: Muscle strength
Exercise that primarily stimulates the musculoskeletal system.
Other Names:
  • No aplicable
Experimental: Mixed
Both aerobic and muscular strength exercises will be performed.
Other: cardiovascular exercise
Exercise that mainly stimulates the cardiovascular and respiratory systems.
Other Names:
  • No aplicable
Other: Muscle strength
Exercise that primarily stimulates the musculoskeletal system.
Other Names:
  • No aplicable
Other: Mixed
Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.
Other Names:
  • No aplicable
No Intervention: Control
Conventional treatment or dyalisis usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health indicators - Dialysis efficiency
Time Frame: 6 months
Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V).
6 months
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.
6 months
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
6 months
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
6 months
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 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months
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
6 months
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.
6 months
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.
6 months
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caloric intake
Time Frame: 6 months
Measured by means of the intake diary
6 months
Number of participants that Smoke
Time Frame: 6 months
Assessed by means of surveys. Absence or presence of smoking habit
6 months
Prevalence of hemodialysis
Time Frame: 6 months
Assessed by clinical history.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Rosario

Investigators

  • Study Chair: Diana Ramos-Caballero, CI, Universidad del Rosario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

February 12, 2028

Study Completion (Estimated)

May 29, 2028

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVO005 769-CV1091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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