Exercise Training and Kidney Transplantation (RENALTX)

Physiological and Molecular Effects of Exercise Training in Kidney Transplantation Recipients

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Inflammation; Muscle Weakness; Chronic Kidney Failure; Solid Organ Transplant Rejection
• Intervention / Treatment: Other: Exercise training; Other: Continue exercising; Other: Discontinue exercising

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 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.

• Study Type: Interventional
• Enrollment (Actual): 345
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 12-week training regimen.	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.; Other Names: Exercise; Exercise therapy; Combined exercise
No Intervention: Control group; Control group will continue their usual care without exercise interventions.
Active Comparator: Continue exercise; 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.	Other: 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.
Active Comparator: Discontinue exercise; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional performance	6-minute walking test	Baseline, after 12-weeks and at the end of the protocol
Muscle strength	One Repetition Maximum Test	Baseline, after 12-weeks and at the end of the protocol
Isometric muscle strength	Handgrip strength	Baseline, after 12-weeks and at the end of the protocol
Physical fitness	Ergospirometric Test	Baseline, after 12-weeks and at the end of the protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory profile	Interleukin 6, interleukin 10, and tumor necrosis factor	Baseline, after 12-weeks and at the end of the protocol
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
Blood glucose	Fasting blood glucose levels	Baseline, after 12-weeks and at the end of the protocol
Hormones	Irisin, Klotho, and adiponectin	Baseline, after 12-weeks and at the end of the protocol
Graft rejection	Number of patients that rejected their graft	Through study completion, an average of 5 years

Collaborators and Investigators

• Sponsor: Hugo de Luca Correa
• Collaborators: Federal University of São Paulo; Catholic University of Brasília

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2015
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Chronic kidney disease; Transplantation; Exercise training; Nephrology; Exercise physiology
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Inflammation; Muscle Weakness; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 50129315.2.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No