Intradialisis Physical Exercise in Quality of Life and Health

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: cardiovascular exercise
* Other: Muscle strength
* Other: Mixed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be 4 parallel groups, 3 intervention and 1 control group.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health indicators - Dialysis efficiency | Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V). | 6 months | 
| Health indicators - KT/V | It is an indicator of the rate of clearance of urea and other wastes by the dialyzer. | 6 months | 
| 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 | 6 months | 
| 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 | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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 | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Health indicators, Quality of life, Hemodialysis, Peritoneal dialysis, Cardiovascular exercise, Resistance exercise