NCT06260579 Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity
| NCT ID | NCT06260579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Physical Activity |
| Study Type | INTERVENTIONAL |
| Enrollment | 147 participants |
| Start Date | 2022-11-14 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 147 participants in total. It began in 2022-11-14 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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).
Frequently Asked Questions
Who can join the NCT06260579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Physical Activity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06260579 currently recruiting?
Yes, NCT06260579 is actively recruiting participants. Visit ClinicalTrials.gov or contact KU Leuven to inquire about joining.
Where is the NCT06260579 trial being conducted?
This trial is being conducted at Ghent, Belgium, Leuven, Belgium.
Who is sponsoring the NCT06260579 clinical trial?
NCT06260579 is sponsored by KU Leuven. The trial plans to enroll 147 participants.