Effect of a Concurrent Physical Exercise Program in Hemodialysis Patients

NCT06664385 | Completed

• 1 other identifier: CEI 2024/1/CR/CL/SFIS/187
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Renal Insufficiency; Hemodialysis

Keywords

Hemodialysis; Functional Capacity; physical exercise; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (1)

concurrent physical exercise

ACTIVE COMPARATOR

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

Interventions

concurrent physical exercise 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.

concurrent physical exercise

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pedro Julian Flores Moreno: lead
• Fabián Rojas Larios: collaborator
• Israel Pérez Palafox: collaborator
• Luis Antonio Bermudez Aceves: collaborator
• Universidad de Colima: collaborator

Study Sites (1)

Centro Estatal de Hemodialisis IMSS bienestar

Colima, Colima, 28060, Mexico

Location

Related Publications (2)

• 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.

  PMID: 29503041 BACKGROUND

• 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.

  PMID: 20098466 BACKGROUND

Related Links

• Magazine containing extensive information on hemodialysis and physical exercise.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Pedro J Flores, Doctor of Medical Sciences

  Universidad de Colima

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The masking consists of the investigator not performing the physical evaluations.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. in Science

Model Details: non controlled clinical trial

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 29, 2024
• Study Start: July 1, 2024
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The information will be available as of August 2025.
• 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.

Locations

ME (1)