Actively Recruiting
Led by KU Leuven · Updated on 2024-02-15
147
Participants Needed
2
Research Sites
217 weeks
Total Duration
K
KU Leuven
Lead Sponsor
U
University Ghent
Collaborating Sponsor
Researchers are evaluating a home-based exercise and physical activity program for adults who have recently received a kidney transplant. This study aims to understand how different exercise intensities affect physical fitness, heart health, gut microbiome characteristics, and quality of life in these patients. The trial also examines the cost-effectiveness and potential for implementing this program in everyday care. The research involves 147 new kidney transplant recipients from two Belgian transplant centers. Participants are randomly assigned to one of three groups for six months of exercise training: a low-intensity group doing flexibility and balance exercises (LIT), a moderate-intensity group performing aerobic and strength training (MIT), or a group starting with moderate intensity and moving to high-intensity aerobic training combined with moderate strength training (MHIT). After this initial phase, the MIT and MHIT groups receive a personalized physical activity program to help maintain an active lifestyle. This includes motivational support, goal-setting, and self-monitoring. The exercise begins three months post-transplant, and the maintenance program starts six months later. Throughout the study, participants will be followed for two years after their transplant. Researchers will measure changes in peak oxygen consumption (a key measure of cardiorespiratory fitness) at 6, 12, and 24 months. They will also assess muscle strength, motor fitness, body composition, cardiovascular health, gut microbiome, quality of life, safety, cost-effectiveness, and how well the program can be implemented. Evaluations will occur at multiple points up to two years after transplantation to understand both short- and long-term effects.
CONDITIONS
Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take part in a 6-month home-based exercise training program at varying intensities depending on their assigned group, including flexibility and balance exercises or moderate to high-intensity aerobic and strength training.
Weekly remote monitoring and periodic assessments
Duration - Up to 18 months following the initial 6-month training
Following the exercise training, participants in the moderate and moderate-high intensity groups receive a personalized physical activity intervention using motivational techniques to support long-term physical activity maintenance.
Regular follow-up contacts with decreasing frequency over time
Duration - Up to 2 years post-transplantation
Participants are monitored for up to 2 years after transplantation to assess physical fitness, cardiovascular health, and other outcomes.
Assessments at 3, 6, 9, 12, and 24 months post-transplant
Total: 2 locations
1
UZ Ghent
Ghent, Belgium, 9000
Actively Recruiting
2
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
A
Amaryllis Van Craenenbroeck, MD, PhD
S
Stefan De Smet, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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Stefan De Smet, Marieke Vandecruys, Jasmine De Beir...
https://pubmed.ncbi.nlm.nih.gov/41215780