Intradialysis Exercise Functional Capacity, Body Composition and Survival in Hemodialysis Patients

Launched by UNIVERSIDAD DE GUANAJUATO · Jan 16, 2025

Keywords

ClinConnect Summary

This study is testing whether a 12-week exercise program done during hemodialysis can improve physical strength, how far people can walk in six minutes, and body composition (the amount of fat and muscle) in adults with kidney disease. It’s a randomized trial taking place at the Universidad de Guanajuato in León, Mexico. Participants are randomly put into one of two groups: an intradialysis exercise group that performs aerobic and resistance exercise during the second hour of dialysis three times weekly for 12 weeks, and a control group that does not do intradialysis exercise but receives standard care plus guidance to exercise at home three times weekly.

Who can join? Adults ages 18 to 50 who are on regular hemodialysis three times a week, have been on dialysis for at least a year, and have their nephrologist’s approval. Exclusion criteria include recent severe heart problems, planned kidney transplant within a year, significant anemia, or being physically very active before joining. Participants will have assessments before and after the 12 weeks, including handgrip strength, a 6-minute walk test, a chair stand test, and measurements such as weight, height, waist, BMI, and body composition, along with at least one blood test. The main goal is to see if the exercise program affects survival about eight months after starting. Enrollment started in January 2025 and the study is expected to finish around May 2026; results are not yet available.

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.