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

NCT06260579 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2024-02-15

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

Exercise/physical activity

personalized exercise training and physical activity program

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • KU Leuven

    lead OTHER

Principal Investigators

  • Amaryllis Van Craenenbroeck, MD, PhD · KU Leuven

  • Patrick Calders, PhD · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2025-09-30
Completion
2029-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06260579 on ClinicalTrials.gov