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

RecruitingNAAges 18 Years - anyAllKU Leuven
NCT06260579 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 tra

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📋 Eligibility rules (as published)
Inclusion Criteria: De novo adult KTRs Exclusion Criteria: * Underlying heart disease, defined as aberrant CPET, unstable angina, non-revascularized lesions or life-threatening arrhythmias * Uncontrolled hypertension * Uncontrolled diabetes, defined as HbA1c ≥ 9% * Musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise * Multi-organ transplantation * Ongoing treatment for malignancies * Unable to understand Dutch * No access to smartphone and/or computer with internet access * Severe pulmonary disease defined as either forced vital capacity (FVC) \<50%, one-second value (FEV1) \<50%, or a diffusing capacity for carbon monoxide (DLCO) \<40% that excludes all serious underlying respiratory disease (pulmonary fibrosis, COPD GOLD II-IV, PAH).
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What it tests

  • Exercise/physical activity
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Where

2 sites
UZ Ghent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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