Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06260579

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult kidney transplant recipients (de novo)
Not Eligible

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

AI-Powered 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

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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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