Effect of a Concurrent Physical Exercise Program in Hemodialysis Patients

October 29, 2024 updated by: Pedro Julian Flores Moreno

Effect of a Concurrent Physical Exercise Program on Quality of Life in Hemodialysis Patients: Uncontrolled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Mexico
      • Colima, Mexico, 28060
        • Centro Estatal de Hemodialisis IMSS bienestar

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the level of quality of life with the SF-36 questionnaire, which ranges from 0 to 100 points, the higher the score, the higher the quality of life.
Time Frame: six weeks
To analyze the quality of life of the patients and after the intervention to measure it again to see if the exercise has an impact on the levels of quality of life.
six weeks

Collaborators and Investigators

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

Sponsor

Pedro Julian Flores Moreno

Collaborators

Universidad de Colima
Fabian Rojas Larios
Israel Pérez Palafox
Luis Antonio Bermudez Aceves

Investigators

  • Study Chair: Pedro J Flores, Doctor of Medical Sciences, Universidad de Colima

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 (Actual)

July 1, 2024

Primary Completion (Actual)

August 9, 2024

Study Completion (Actual)

August 9, 2024

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 27, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI 2024/1/CR/CL/SFIS/187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the plan to share information with other researchers is through the publication of different articles that can be extracted from the research.

IPD Sharing Time Frame

The information will be available as of August 2025.

IPD Sharing Access Criteria

In order to have access to these data, other researchers must be performing the same methodological design, so there is no point in sharing it with a different study design.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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