Chronic Kidney Failure, Inflammation, Muscle Weakness, Quality of Life, Solid Organ Transplant Rejection
Conditions
Keywords
Exercise training, Nephrology, Transplantation, Chronic kidney disease, Exercise physiology, Quality of life
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.
Interventions
OTHERExercise training
Participants will engage in combined training five times a week, with activities including 2 minutes of stationary marching and a set of 15 repetitions for squats, bilateral hip abduction, plantar flexion, floor abdominal exercises, and arm flexion with the knee close to the ground. Additionally, twice a week on non-consecutive days, volunteers partake in 20 minutes of aerobic walking. The second program starts with a 2-minute stationary march, followed by 2 sets of 12 repetitions for free squats, hip abduction, plantar flexion, stiff-legged deadlifts, arm flexion with knee support, floor abdominal exercises, and concludes with 30 minutes of aerobic exercise. The third program starts with a 2-minute stationary march, followed by 3 sets of 12 repetitions for free squats, hip abduction, plantar flexion, stiff-legged deadlifts, arm flexion, floor abdominal exercises, and includes thrice-weekly aerobic sessions lasting 30 minutes each.
OTHERContinue exercising
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will include individuals who choose to persist with their exercise routine.
OTHERDiscontinue exercising
Following the 24-week training regimen, patients will have the option to decide whether they wish to continue their exercise training. This group will comprise individuals who opted not to continue their exercise routine.
Sponsors
Hugo de Luca Correa
Catholic University of Brasília
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Inability to Comply * Cognitive disorders * Unwillingness to Continue * Unstable Health Conditions * Physical limitations during the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical fitness - VO2peak | Baseline, after 24-weeks and at the end of the protocol | Cardiopulmonary test |
| Isometric muscle strength | Baseline, after 24-weeks and at the end of the protocol | Handgrip strength |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Graft rejection | Through study completion, an average of 2 years | Number of patients that rejected their graft |
Outcome results
None listed