Home-based exercise program for kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.