Clinical trial NCT06216015: Exercise Training and Kidney Transplantation
Official title: Physiological and Molecular Effects of Exercise Training in Kidney Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Organ Transplant Rejection
Chronic Kidney Failure
Quality of Life
Inflammation
Muscle Weakness
Keywords: Exercise training
Nephrology
Transplantation
Chronic kidney disease
Exercise physiology
Quality of life
Lead sponsor: Catholic University of Brasília
Sponsor class: OTHER
Collaborators: name: Catholic University of Brasília
name: Federal University of São Paulo
First posted: 2024-01-22
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 12-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 12 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional performance
timeFrame: Baseline, after 12-weeks and at the end of the protocol
measure: Muscle strength
timeFrame: Baseline, after 12-weeks and at the end of the protocol
measure: Isometric muscle strength
timeFrame: Baseline, after 12-weeks and at the end of the protocol
measure: Physical fitness
timeFrame: Baseline, after 12-weeks and at the end of the protocol
Secondary outcomes:
measure: Inflammatory profile
timeFrame: Baseline, after 12-weeks and at the end of the protocol
measure: Urea-to-creatinine ratio
timeFrame: Baseline, after 12-weeks and at the end of the protocol
measure: Blood glucose
timeFrame: Baseline, after 12-weeks and at the end of the protocol
measure: Hormones
timeFrame: Baseline, after 12-weeks and at the end of the protocol
measure: Graft rejection
timeFrame: Through study completion, an average of 5 years
Other outcomes:
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