Exercise Training in Kidney Transplant Recipients (EXTRA Trial) Evaluating Physiological and Molecular Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345
- 主要终点
- Functional performance
研究概览
简要总结
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:
- Can exercise training improve physical fitness and muscle strength in transplant recipients?
- Can exercise training modulate inflammatory profile, hormones, lipid profile, and exercise-induced molecules in transplant recipients?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Inability to Comply
- •Cognitive disorders
- •Unwillingness to Continue
- •Unstable Health Conditions
- •Physical limitations during the protocol
研究组 & 干预措施
Control group
Control group will continue their usual care without exercise interventions.
Exercise training group
The training programs will encompass three phases, with a gradual progression in both intensity and duration. Each phase will span a duration of four weeks, culminating in a comprehensive 24-week training regimen.
干预措施: Exercise training (Other)
Continue exercise
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.
干预措施: Continue exercising (Other)
Discontinue exercise
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.
干预措施: Discontinue exercising (Other)
结局指标
主要结局
Functional performance
时间窗: Baseline, after 24-weeks and at the end of the protocol
6-minute walking test
Muscle strength
时间窗: Baseline, after 24-weeks and at the end of the protocol
One Repetition Maximum Test
Isometric muscle strength
时间窗: Baseline, after 24-weeks and at the end of the protocol
Handgrip strength
Physical fitness
时间窗: Baseline, after 24-weeks and at the end of the protocol
Ergospirometric Test
次要结局
- Inflammatory profile(Baseline, after 24-weeks and at the end of the protocol)
- Urea-to-creatinine ratio(Baseline, after 24-weeks and at the end of the protocol)
- Blood glucose(Baseline, after 24-weeks and at the end of the protocol)
- Hormones(Baseline, after 24-weeks and at the end of the protocol)
- Graft rejection(Through study completion, an average of 2 years)
研究者
Hugo de Luca Correa
Principal Investigator
Catholic University of Brasília