Solid Organ Transplant RejectionEXTRANCT06216015
Exercise Training and Kidney Transplantation
A study testing Exercise training, Continue exercising and Discontinue exercising in people with Solid Organ Transplant Rejection and Chronic Kidney Failure, run by Hugo de Luca Correa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Solid Organ Transplant Rejection, Chronic Kidney Failure, Quality of Life
- What is being tested?
- Exercise training, Continue exercising and Discontinue exercising
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Inability to Comply
- Cognitive disorders
- Unwillingness to Continue
- Unstable Health Conditions
- Physical limitations during the protocol
About this study
Official title: Exercise Training in Kidney Transplant Recipients (EXTRA Trial) Evaluating Physiological and Molecular Outcomes
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?
Read more
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.
Read the 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.
- Conditions
- Solid Organ Transplant Rejection, Chronic Kidney Failure, Quality of Life, Inflammation, Muscle Weakness
- Being tested
- Exercise training, Continue exercising, Discontinue exercising
- Keywords
- Exercise training, Nephrology, Transplantation, Chronic kidney disease, Exercise physiology, Quality of life
- Medical subject headings
- Kidney Failure, Chronic, Inflammation, Muscle Weakness, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called Exercise therapy, Exercise, Combined exercise
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.
Continue exercisingOther
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 exercisingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training group | Experimental | 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. Receives: Other: Exercise training |
| Control group | No intervention | Control group will continue their usual care without exercise interventions. |
| Continue exercise | Active comparator | 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. Receives: Other: Continue exercising |
| Discontinue exercise | Active comparator | 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. Receives: Other: Discontinue exercising |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fitness - VO2peak
Cardiopulmonary test
Measured: Baseline, after 24-weeks and at the end of the protocol
Isometric muscle strength
Handgrip strength
Measured: Baseline, after 24-weeks and at the end of the protocol
Secondary outcomes (4)
Inflammatory profile
Interleukin 6, interleukin 10, and tumor necrosis factor
Measured: Baseline, after 24-weeks and at the end of the protocol
Urea-to-creatinine ratio
Urea and creatinine will be combined to report urea-to-creatinine ratio
Measured: Baseline, after 24-weeks and at the end of the protocol
Blood glucose
Fasting blood glucose levels
Measured: Baseline, after 24-weeks and at the end of the protocol
Graft rejection
Number of patients that rejected their graft
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study startDec 2015
- Primary completion3 Nov 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo de Luca Correa
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of Brasília, Federal University of São Paulo
- Responsible party
- Sponsor-investigator, Hugo de Luca Correa, Catholic University of Brasília
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216015
- Sponsor's protocol ID
- 79266224.1.0000.0029
- Acronym
- EXTRA
- Status last verified
- Sep 2026
- First submitted
- 1 Jan 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in exercise and transplantation. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Kidney Transplant Recipients (EXTRA Trial) Evaluating Physiological and Molecular Outcomes
- ClinicalTrials.gov ID
- NCT06216015
- Acronym / sponsor ID
- EXTRA / 79266224.1.0000.0029
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Hugo de Luca CorreaUniversity, hospital or other
- Collaborators
- Catholic University of Brasília, Federal University of São Paulo
- Study start
- Dec 2015 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise training group | Experimental | Other: Exercise trainingThe 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. |
| Control group | No intervention | –Control group will continue their usual care without exercise interventions. |
| Continue exercise | Active comparator | Other: Continue exercisingFollowing 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 exercise | Active comparator | Other: Discontinue exercisingFollowing 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Medical Authorization:
- Stable Health Status
- Medication Consistency
- No History of Severe Cardiovascular Events
- No Major Orthopedic Issues
Key exclusion criteria (5 listed)
- Inability to Comply
- Cognitive disorders
- Unwillingness to Continue
- Unstable Health Conditions
- Physical limitations during the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingAlso: Exercise therapy, Exercise, Combined exerciseParticipants 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 | Exercise training group |
| Continue exercisingFollowing 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. | Other | Continue exercise |
| Discontinue exercisingFollowing 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. | Other | Discontinue exercise |
Primary outcome
Physical fitness - VO2peak
Time frame: Baseline, after 24-weeks and at the end of the protocol
Cardiopulmonary test
Isometric muscle strength
Time frame: Baseline, after 24-weeks and at the end of the protocol
Handgrip strength
4 secondary outcomes
Inflammatory profile
Time frame: Baseline, after 24-weeks and at the end of the protocol
Urea-to-creatinine ratio
Time frame: Baseline, after 24-weeks and at the end of the protocol
Blood glucose
Time frame: Baseline, after 24-weeks and at the end of the protocol
Graft rejection
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in exercise and transplantation. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Related trials for Solid Organ Transplant Rejection
RecruitingPhase 1
Phase I Trial on the Safety of Delayed Infusion of a Naïve T Cell-Depleted Hematopoietic Graft With Memory T Cells in Solid Organ Transplant Recipients
Solid Organ Transplant Complications, Solid Organ Transplant Recipients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training, Continue exercising and Discontinue exercising in people with Solid Organ Transplant Rejection and Chronic Kidney Failure, run by Hugo de Luca Correa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical fitness - VO2peak (time frame: Baseline, after 24-weeks and at the end of the protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.