Exercise Training and Kidney Transplantation

NCT06216015 | Completed DMC

• 1 other identifier: 50129315.2.0000.5505
• Study Type: interventional
• Target: 345
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Can exercise training improve physical fitness and muscle strength in transplant recipients?
2. 2.Can exercise training modulate inflammatory profile, hormones, lipid profile, and exercise-induced molecules in transplant recipients?
3. 3.Can exercise training improve blood pressure and endothelial health in transplant patients?

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

Outcome Measures

Primary Outcomes (4)

• Functional performance

  6-minute walking test

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

• Muscle strength

  One Repetition Maximum Test

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

• Isometric muscle strength

  Handgrip strength

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

• Physical fitness

  Ergospirometric Test

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

Secondary Outcomes (5)

• Inflammatory profile

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

• Urea-to-creatinine ratio

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

• Blood glucose

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

• Hormones

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

• Graft rejection

  Through study completion, an average of 2 years

Study Arms (4)

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.

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.

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.

Other: Discontinue exercising

Interventions

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.

Also known as: Exercise therapy, Exercise, Combined exercise

Exercise training group

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.

Continue exercise

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.

Discontinue exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inability to Comply
• Cognitive disorders
• Unwillingness to Continue
• Unstable Health Conditions
• Physical limitations during the protocol

Sponsors & Collaborators

• Hugo de Luca Correa: lead
• Catholic University of Brasília: collaborator
• Federal University of São Paulo: collaborator

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation; Muscle Weakness; Renal Insufficiency, Chronic

Interventions

Exercise; Exercise Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 22, 2024
• Study Start: September 30, 2015
• Primary Completion: November 3, 2023
• Study Completion: December 5, 2023
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• 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
• 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).