NCT06788054Enrolling by invitation
Intradialysis Exercise Functional Capacity, Body Composition and Survival in Hemodialysis Patients
Effect of a 12-week Intradialysis Exercise Program on Functional Capacity, Body Composition and Survival in Hemodialysis Patients: a Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Chronic kidney disease and renal replacement treatments (hemodialysis, peritoneal dialysis, kidney transplant) produce various alterations at the level of muscle, bones, fat content and the heart; can alter physical capabilities such as muscle strength, resistance to climb a step repeatedly intensely, and the ability to move the joints freely, in addition to producing an increase or decrease in weight and alterations in its distribution (for example, decreasing muscle and increase fat). The above, added to the particular factors of hemodialysis such as the reduction in daily time to exercise due to the sessions, or the fatigue after it, can together generate greater repercussions on functional capacity and thus increase the risk of suffering from cardiovascular problems. and accelerate the evolution of the disease. Therefore, this study aims to determine the effect of a 12-week supervised physical exercise program during hemodialysis on strength and ability to move, the amount of fat and muscle in the body, as well as bone wear. ; and compare these results with a group of patients who do not perform supervised exercise. In addition, it will be determined how exercise can act in the long term, preventing the risk of hospitalization and death due to cardiovascular causes. The above is useful in order to establish recommendations and protocols that help us increase the quality of life and survival of the person.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 3 Jan 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Universidad de Guanajuato
- Diseases
- Chronic kidney disease
- NCT number
- NCT06788054
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 20 Jan 2025 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who receive a kidney transplant during the development of the exercise protocol or follow-up during the 8-month follow-up period.
Other illness
- 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.
Other
- When the patient voluntarily decides to leave the study.
- When the patient begins additional strength or aerobic training.
- Patients who decide to belong to the group that will perform intradialytic exercise.
- When for any reason the exercise is suspended for more than three continuous times.
Who the study is looking for
- Male and female patients aged between 18-50 years.
- Patients who receive regular hemodialysis sessions 3 times a week, reported through the clinical record.
- Patients with a clinical history of being treated with HD for at least 1 previous year (reported by clinical record).
- Patients without a history of myocardial infarction in the last 3 months (reported by clinical record).
- Patients who are not in a kidney transplant protocol to be performed during the next 12 months.
- Patients who have permission from their nephrology specialist to participate.
- Patients who agree to participate in the study, and who voluntarily sign the informed consent (IC) form.
- Patients without a history of coronary artery disease in the last 4 months (reported by clinical record).
- Patients without myocardial instability (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias), reported by clinical record.
- Patients without active infectious process (reported by clinical record).
- Patients without extreme changes in blood glucose levels (hyperglycemia or hypoglycemia), reported by clinical record.
- Patients without neurological, respiratory or skeletal muscle diseases or disorders that are aggravated by exercise (reported by clinical record).
- Patients without inability to sit, stand or walk without assistance (walking device such as cane or walker is allowed) self-reported.
- Patients without severe anemia (Hb \< 8.0 g/dL), reported by clinical record.
- Female patients should not be under sex hormone treatment or hormone replacement therapy for menopause (self-reported).
- Patients without lupus erythematosus as the etiology of CKD, reported by clinical record.
- 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).
- Patients who do not have amputations of any of the extremities.
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Departamento de Ciencias Médicas Universidad de Guanajuato Coordinator of this site? Confirm its status | León | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.