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NCT Number: NCT06216015

Exercise Training and Kidney Transplantation

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.

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Key information

Conditions

Solid Organ Transplant Rejection Chronic Disease Chronic Kidney Failure Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

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.

Other names: Exercise therapy, Exercise, Combined exercise

Continue exercising

Other

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.

Discontinue exercising

Other

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.

Primary outcomes

  1. Physical fitness - VO2peak

    Time frame: Baseline, after 24-weeks and at the end of the protocol

    Cardiopulmonary test

  2. Isometric muscle strength

    Time frame: Baseline, after 24-weeks and at the end of the protocol

    Handgrip strength

Secondary outcomes

  1. Inflammatory profile

    Time frame: Baseline, after 24-weeks and at the end of the protocol

    Interleukin 6, interleukin 10, and tumor necrosis factor

  2. Urea-to-creatinine ratio

    Time frame: Baseline, after 24-weeks and at the end of the protocol

    Urea and creatinine will be combined to report urea-to-creatinine ratio

  3. Blood glucose

    Time frame: Baseline, after 24-weeks and at the end of the protocol

    Fasting blood glucose levels

  4. Graft rejection

    Time frame: Through study completion, an average of 2 years

    Number of patients that rejected their graft

Sponsors and collaborators

Lead sponsor

Hugo de Luca Correa

Other

Collaborators

  • Catholic University of Brasília
  • Federal University of São Paulo

Registry information

Official study title

Exercise Training in Kidney Transplant Recipients (EXTRA Trial) Evaluating Physiological and Molecular Outcomes

Acronym: EXTRA

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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