Actively Recruiting
Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity
Led by KU Leuven · Updated on 2024-02-15
147
Participants Needed
2
Research Sites
367 weeks
Total Duration
On this page
Sponsors
K
KU Leuven
Lead Sponsor
U
University Ghent
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult kidney transplant recipients (de novo)
You will not qualify if you...
- Heart disease such as unstable angina, abnormal exercise test, non-revascularized lesions, or dangerous arrhythmias
- Uncontrolled high blood pressure
- Uncontrolled diabetes with HbA1c 9% or higher
- Musculoskeletal disorders preventing exercise on a cycle ergometer or other medical reasons contraindicating moderate or high-intensity exercise
- Multi-organ transplantation
- Ongoing cancer treatment
- Unable to understand Dutch
- No access to smartphone or computer with internet
- Severe lung disease defined by specific lung function measurements indicating serious respiratory illness
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UZ Ghent
Ghent, Belgium, 9000
Actively Recruiting
2
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
A
Amaryllis Van Craenenbroeck, MD, PhD
CONTACT
S
Stefan De Smet, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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