Exercise Training and Kidney Transplantation (EXTRA)

Hugo de Luca Correa

Status: Completed

Conditions: Chronic Kidney Failure; Inflammation; Quality of Life; Muscle Weakness; Solid Organ Transplant Rejection

Treatments: Other: Continue exercising; Other: Exercise training; Other: Discontinue exercising

Study type: Interventional

Funder types: Other

Identifiers

NCT06216015

50129315.2.0000.5505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 345 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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345 participants in 4 patient groups

Exercise training group

Experimental group

Description:

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.

Treatment:

Other: Exercise training

Control group

No Intervention group

Description:

Control group will continue their usual care without exercise interventions.

Continue exercise

Active Comparator group

Description:

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.

Treatment:

Other: Continue exercising

Discontinue exercise

Active Comparator group

Description:

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.

Treatment:

Other: Discontinue exercising