Effect of a Concurrent Physical Exercise Program in Hemodialysis Patients

NCT ID: NCT06664385

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-08-09

Brief Summary

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Concurrent physical exercise is the method of combining strength and endurance that can be worked with in one session or in an exercise program. Therefore, the researchers seek to implement it in patients suffering from chronic renal failure with hemodialysis therapy and see if concurrent physical exercise improves quality of life levels and at the same time see the response of physical fitness, body composition and biochemistry.

Detailed Description

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Introduction: The performance of physical exercise has positive effects in terms of quality of life, but when it is not performed consistently it triggers a sedentary lifestyle, which is reflected in overweight and obesity, in addition to developing chronic noncommunicable diseases, propitiating chronic kidney disease, which although, hereditary and environmental factors are also present in this pathology and as the disease progresses, chronic renal failure develops. Objective: To analyze the effect of a concurrent physical exercise program on quality of life in patients with chronic renal failure undergoing hemodialysis. Methods: Uncontrolled clinical trial in which a concurrent physical exercise program will be carried out for 6 weeks, performing physical evaluations such as 6-minute walk and manual strength by dynamometer, application of SF-36 questionnaires, measurement of urea, glucose, creatinine and albumin, in addition to analyzing body composition by electrical bioimpedance.

Conditions

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Chronic Renal Insufficiency Hemodialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

non controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The masking consists of the investigator not performing the physical evaluations.

Study Groups

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concurrent physical exercise

It consists of an exercise method that combines strength and endurance. It has a duration of 6 weeks divided into three stages, adaptation, development and maintenance. That for the intervention group and for the control group will only be performing aerobic physical exercise according to their physical tolerance.

Group Type ACTIVE_COMPARATOR

concurrent physical exercise

Intervention Type OTHER

It consists of a periodization which consists of three moments adapted to the patient's needs distributed in 6 weeks and increasing the intensity gradually.

Interventions

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concurrent physical exercise

It consists of a periodization which consists of three moments adapted to the patient's needs distributed in 6 weeks and increasing the intensity gradually.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are cared for at the State Hemodialysis Center.
* Receive hemodialysis treatment 3 times per week.
* Sign the informed consent form.

Exclusion Criteria

* Patients under 18 years of age.
* Patients with a history of fracture at less than 2 months of evolution.
* Patients with any rheumatologic disease (lupus or rheumatoid arthritis).
* Prostrate patients.
* Amputee patients.
* Positive patients (HIV).
* Uncontrolled comorbidities.

Elimination.

* Patients who make their voluntary withdrawal from the project. Inability to engage in physical exercise.
* Death.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fabián Rojas Larios

UNKNOWN

Sponsor Role collaborator

Israel Pérez Palafox

UNKNOWN

Sponsor Role collaborator

Luis Antonio Bermudez Aceves

UNKNOWN

Sponsor Role collaborator

Universidad de Colima

OTHER

Sponsor Role collaborator

Pedro Julian Flores Moreno

OTHER

Sponsor Role lead

Responsible Party

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Pedro Julian Flores Moreno

Ph.D. in Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pedro J Flores, Doctor of Medical Sciences

Role: STUDY_CHAIR

Universidad de Colima

Locations

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Centro Estatal de Hemodialisis IMSS bienestar

Colima, Colima, Mexico

Site Status

Countries

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Mexico

References

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Molina-Robles E, Colomer-Codinachs M, Roquet-Bohils M, Chirveches-Perez E, Ortiz-Jurado P, Subirana-Casacuberta M. Effectiveness of an educational intervention and physical exercise on the functional capacity of patients on haemodialysis. Enferm Clin (Engl Ed). 2018 May-Jun;28(3):162-170. doi: 10.1016/j.enfcli.2017.12.003. Epub 2018 Mar 2. English, Spanish.

Reference Type BACKGROUND
PMID: 29503041 (View on PubMed)

Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.

Reference Type BACKGROUND
PMID: 20098466 (View on PubMed)

Related Links

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https://www.nefrologiaaldia.org

Magazine containing extensive information on hemodialysis and physical exercise.

Other Identifiers

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CEI 2024/1/CR/CL/SFIS/187

Identifier Type: -

Identifier Source: org_study_id

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