Clinical trial NCT06664385: Effect of a Concurrent Physical Exercise Program in Hemodialysis Patients
Official title: Effect of a Concurrent Physical Exercise Program on Quality of Life in Hemodialysis Patients: Uncontrolled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Insufficiency
Hemodialysis
Keywords: Hemodialysis
Functional Capacity
physical exercise
Quality of life
Lead sponsor: Universidad de Colima
Sponsor class: OTHER
Collaborators: name: Fabián Rojas Larios
name: Israel Pérez Palafox
name: Luis Antonio Bermudez Aceves
name: Universidad de Colima
First posted: 2024-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: non controlled clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Colima
country: Mexico
facility: Centro Estatal de Hemodialisis IMSS bienestar
Study officials:
affiliation: Universidad de Colima
name: Pedro J Flores, Doctor of Medical Sciences
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.