Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity

This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.

NCT Number	NCT06260579
Lead Sponsor	KU Leuven Collaborators: University Ghent
Conditions	Physical Activity, Exercise Training, Kidney Transplantation, Physical Fitness, Cardiovascular Health, Gut Microbiome, Health-related Quality of Life, Implementation +1 more
Enrollment	147 participants
Start Date	2022-11-14
Primary Completion	2025-09-30 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2024-02-15