Home-based exercise program for kidney transplant recipients
A Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity - a Multicenter Randomized Controlled Trial
This study is testing whether a home-based exercise program can help kidney transplant recipients improve their fitness and overall health compared to different levels of exercise intensity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 2 sites (Ghent and 1 other locations) |
| Trial ID | NCT06260579 on ClinicalTrials.gov |
What this trial studies
This multicentre randomized controlled trial evaluates the effectiveness and cost-effectiveness of a home-based exercise and physical activity intervention for de novo kidney transplant recipients. Participants will be randomly assigned to one of three groups: a low-intensity training group, a moderate-intensity training group, or a moderate- and high-intensity training group. The study aims to improve physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life over a six-month period. Following the intervention, a maintenance phase will promote a physically active lifestyle for participants in the moderate-intensity groups.
Who should consider this trial
Good fit: Ideal candidates for this study are adult de novo kidney transplant recipients who are physically able to participate in an exercise program.
Not a fit: Patients with uncontrolled hypertension, uncontrolled diabetes, severe pulmonary disease, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the physical fitness and overall health of kidney transplant recipients, potentially reducing their cardiovascular risk.
How similar studies have performed: Previous studies have shown positive outcomes with exercise interventions in transplant populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Ghent and 1 other locations
- UZ Ghent — Ghent, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Amaryllis Van Craenenbroeck, MD, PhD — KU Leuven
- Study coordinator: Amaryllis Van Craenenbroeck, MD, PhD
- Email: amaryllis.vancraenenbroeck@kuleuven.be
- Phone: +3216344580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.