Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impac
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 characteri
| Condition(s) | Physical Activity, Exercise Training, Kidney Transplantation, Physical Fitness, Cardiovascular Health, Gut Microbiome, Health-related Quality of Life, Implementation, Cost-effectiveness |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 activ |
| Who can participate | 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) \<4 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | KU Leuven |
| Locations | Ghent, Belgium; Leuven, Belgium |
| Start date | 2022-11-14 |
| NCT ID | NCT06260579 |
| Official listing | https://clinicaltrials.gov/study/NCT06260579 |