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

Universidad del Rosario

Status: Not yet enrolling

Conditions: Chronic Kidney Diseases

Treatments: Other: cardiovascular exercise; Other: Muscle strength; Other: Mixed

Study type: Interventional

Funder types: Other

Identifiers

NCT05207527

DVO005 769-CV1091

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Cardiovascular exercise

Experimental group

Description:

Cycloergometer

Treatment:

Other: cardiovascular exercise

Muscle strength

Experimental group

Description:

Strength exercises will be performed during the hemodialysis session.

Treatment:

Other: Muscle strength

Mixed

Experimental group

Description:

Both aerobic and muscular strength exercises will be performed.

Treatment:

Other: Mixed

Other: Muscle strength

Other: cardiovascular exercise

Control

No Intervention group

Description:

Conventional treatment or dyalisis usual care