Intradialysis Exercise Functional Capacity, Body Composition and Survival in Hemodialysis Patients
Launched by UNIVERSIDAD DE GUANAJUATO · Jan 16, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Background: In Mexico, Chronic Kidney Disease (CKD) has a high prevalence and is considered one of the leading causes of death. Hemodialysis (HD) is the primary renal replacement therapy; however, it is associated with significant declines in functional capacity, body composition alterations, morbidity, hospitalization, and mortality with rates that can be 30% higher than those in the general population not on HD. It is estimated that 50% of patients die within the first three years of starting HD, primarily due to cardiovascular complications. Intradialytic exercise has been linked to impr...
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Male and female patients aged between 18-50 years.
- • 2. Patients who receive regular hemodialysis sessions 3 times a week, reported through the clinical record.
- • 3. Patients with a clinical history of being treated with HD for at least 1 previous year (reported by clinical record).
- • 4. Patients without a history of myocardial infarction in the last 3 months (reported by clinical record).
- • 5. Patients who are not in a kidney transplant protocol to be performed during the next 12 months.
- • 6. Patients who have permission from their nephrology specialist to participate.
- • 7. Patients who agree to participate in the study, and who voluntarily sign the informed consent (IC) form.
- • 8. Patients without a history of coronary artery disease in the last 4 months (reported by clinical record).
- • 9. Patients without myocardial instability (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias), reported by clinical record.
- • 10. Patients without active infectious process (reported by clinical record).
- • 11. Patients without extreme changes in blood glucose levels (hyperglycemia or hypoglycemia), reported by clinical record.
- • 12. Patients without neurological, respiratory or skeletal muscle diseases or disorders that are aggravated by exercise (reported by clinical record).
- • 13. Patients without inability to sit, stand or walk without assistance (walking device such as cane or walker is allowed) self-reported.
- • 14. Patients without severe anemia (Hb \< 8.0 g/dL), reported by clinical record.
- • 15. Female patients should not be under sex hormone treatment or hormone replacement therapy for menopause (self-reported).
- • 16. Patients without lupus erythematosus as the etiology of CKD, reported by clinical record.
- • 17. Physically inactive (Do not perform physical exercise of more than 150 minutes per week on a regular basis according to data from the World Health Organization).
- • 18. Patients who do not have amputations of any of the extremities.
- Exclusion criteria:
- • 1. If the patient presents any disease, or neurological, respiratory or skeletal muscle disorder during the development of the physical capacity tests, or during the execution of the protocol, which is aggravated by the practice of physical exercise.
- • 2. When the patient voluntarily decides to leave the study.
- • 3. When the patient begins additional strength or aerobic training.
- • 4. Patients who receive a kidney transplant during the development of the exercise protocol or follow-up during the 8-month follow-up period.
- • 5. Patients who decide to belong to the group that will perform intradialytic exercise.
- • 6. When for any reason the exercise is suspended for more than three continuous times.
About Universidad De Guanajuato
The Universidad de Guanajuato is a prestigious academic institution in Mexico, recognized for its commitment to advancing research and education in the health sciences. With a strong emphasis on innovation and interdisciplinary collaboration, the university actively engages in clinical trials aimed at improving healthcare outcomes and addressing pressing medical challenges. The institution is equipped with state-of-the-art facilities and a dedicated team of experienced researchers and clinicians, fostering an environment that promotes ethical standards and rigorous scientific inquiry. Through its clinical trial initiatives, Universidad de Guanajuato aims to contribute valuable insights to the global medical community while enhancing the health and well-being of diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
León, Guanajuato, Mexico
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported