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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06216015
Other study ID # 50129315.2.0000.5505
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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