RecruitingNot ApplicableNCT06260579

Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity

A Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity - a Multicenter Randomized Controlled Trial

Sponsor

KU Leuven

Enrollment

147 participants

Start Date

Nov 14, 2022

Study Type

INTERVENTIONAL

Conditions

Exercise Training Physical Activity Implementation Gut Microbiome Kidney Transplantation Health-related Quality of Life Cardiovascular Health Physical Fitness Cost-effectiveness

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

Min Age: 18 Years

Inclusion Criteria1

De novo adult KTRs

Exclusion Criteria9

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).

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