Exercise Training and Kidney Transplantation

Quality of Life Clinical Trial

— RENALTX  

Official title:

Physiological and Molecular Effects of Exercise Training in Kidney Transplantation Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06216015
• Other study ID #: 50129315.2.0000.5505
• Status: Completed
• Phase: N/A
• Start date: September 30, 2015
• Est. completion date: December 5, 2023

Study information

• Verified date: January 2024
• Source: Catholic University of Brasília
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: December 5, 2023
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Inflammation
• Kidney Failure, Chronic
• Muscle Weakness
• Quality of Life
• Renal Insufficiency
• Solid Organ Transplant Rejection

Intervention

Other:
• Exercise training
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 exercising
Following the 12-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
Following the 12-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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hugo de Luca Correa	Catholic University of Brasília, Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional performance	6-minute walking test	Baseline, after 12-weeks and at the end of the protocol
Primary	Muscle strength	One Repetition Maximum Test	Baseline, after 12-weeks and at the end of the protocol
Primary	Isometric muscle strength	Handgrip strength	Baseline, after 12-weeks and at the end of the protocol
Primary	Physical fitness	Ergospirometric Test	Baseline, after 12-weeks and at the end of the protocol
Secondary	Inflammatory profile	Interleukin 6, interleukin 10, and tumor necrosis factor	Baseline, after 12-weeks and at the end of the protocol
Secondary	Urea-to-creatinine ratio	Urea and creatinine will be combined to report urea-to-creatinine ratio	Baseline, after 12-weeks and at the end of the protocol
Secondary	Blood glucose	Fasting blood glucose levels	Baseline, after 12-weeks and at the end of the protocol
Secondary	Hormones	Irisin, Klotho, and adiponectin	Baseline, after 12-weeks and at the end of the protocol
Secondary	Graft rejection	Number of patients that rejected their graft	Through study completion, an average of 5 years