Exercise Training and Kidney Transplantation
- Conditions
- Solid Organ Transplant RejectionMuscle WeaknessChronic Kidney FailureQuality of LifeInflammation
- Registration Number
- NCT06216015
- Lead Sponsor
- Hugo de Luca Correa
- Brief Summary
The goal of this clinical trial is to investigate the physiological and molecular effects of exercise training in transplant recipients. The main questions it aims to answer are:
1. Can exercise training improve physical fitness and muscle strength in transplant recipients?
2. Can exercise training modulate inflammatory profile, hormones, lipid profile, and exercise-induced molecules in transplant recipients?
3. Can exercise training improve blood pressure and endothelial health in transplant patients?
Participants will be invited to an exercise training program 6-month after their transplant surgery. Body composition, physical assessment, and blood draw will be assessed at baseline and 24-weeks after exercise or control regimen.
Researchers will compare exercise group vs. routine care group to see if exercise training impact the health-related outcomes of this population.
- Detailed Description
The study will involve inviting participants to join an exercise training program six months after their transplant surgery. The research will include baseline assessments and measurements, such as body composition, physical assessment, and blood draws. These assessments will be conducted both at the beginning of the study and 24 weeks after participants have undergone either the exercise regimen or a control regimen.
The research team will compare two groups: the exercise group and the routine care group. The goal is to examine whether participating in an exercise training program has a significant impact on various health-related outcomes in transplant recipients when compared to individuals receiving standard care.
This clinical trial seeks to understand the potential benefits of exercise training on physical fitness, quality of life, inflammatory and molecular profiles, as well as cardiovascular health in individuals who have undergone organ transplantation. The comparison between the exercise group and the routine care group will provide valuable insights into the effectiveness of exercise interventions for this specific population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 345
- Medical Authorization:
- Stable Health Status
- Medication Consistency
- No History of Severe Cardiovascular Events
- No Major Orthopedic Issues
- Non-Smokers or Consistent Smoking Habits
- Ability to Comply with Study Protocols
- Inability to Comply
- Cognitive disorders
- Unwillingness to Continue
- Unstable Health Conditions
- Physical limitations during the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Functional performance Baseline, after 24-weeks and at the end of the protocol 6-minute walking test
Muscle strength Baseline, after 24-weeks and at the end of the protocol One Repetition Maximum Test
Isometric muscle strength Baseline, after 24-weeks and at the end of the protocol Handgrip strength
Physical fitness Baseline, after 24-weeks and at the end of the protocol Ergospirometric Test
- Secondary Outcome Measures
Name Time Method Inflammatory profile Baseline, after 24-weeks and at the end of the protocol Interleukin 6, interleukin 10, and tumor necrosis factor
Urea-to-creatinine ratio Baseline, after 24-weeks and at the end of the protocol Urea and creatinine will be combined to report urea-to-creatinine ratio
Blood glucose Baseline, after 24-weeks and at the end of the protocol Fasting blood glucose levels
Hormones Baseline, after 24-weeks and at the end of the protocol Irisin, Klotho, and adiponectin
Graft rejection Through study completion, an average of 2 years Number of patients that rejected their graft