Clinical trial NCT05207527: Intradialisis Physical Exercise in Quality of Life and Health
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Chronic kidney disease
Health indicators
Quality of life
Hemodialysis
Peritoneal dialysis
Cardiovascular exercise
Resistance exercise
Lead sponsor: Universidad del Rosario
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be 4 parallel groups, 3 intervention and 1 control group.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Health indicators - Dialysis efficiency
timeFrame: 6 months
measure: Health indicators - KT/V
timeFrame: 6 months
measure: Health indicators - Sarcopenia
timeFrame: 6 months
measure: Kidney Disease and Quality of Life (KDQOL-36)
timeFrame: 6 months
measure: Physical condition - Body composition1
timeFrame: 6 months
measure: Physical condition - Body composition2
timeFrame: 6 months
measure: Physical condition - Body composition3
timeFrame: 6 months
measure: Physical condition - Body composition4
timeFrame: 6 months
measure: Physical condition - Body composition5
timeFrame: 6 months
measure: Muscle strength
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
measure: Functional capacity - SPPB
timeFrame: 6 months
measure: Functional capacity -6MWT
timeFrame: 6 months
measure: Functional capacity - 2MT
timeFrame: 6 months
Secondary outcomes:
measure: Depression and anxiety (Beck Scale)
timeFrame: 6 months
Other outcomes:
measure: Caloric intake
timeFrame: 6 months
measure: Number of participants that Smoke
timeFrame: 6 months
measure: Prevalence of hemodialysis
timeFrame: 6 months
Locations:
Study officials:
affiliation: Universidad del Rosario
name: Diana Ramos-Caballero, CI
role: STUDY_CHAIR
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