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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• De novo adult KTRs

Locations
Other Locations
Belgium
UZ Ghent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Amaryllis Van Craenenbroeck, MD, PhD
amaryllis.vancraenenbroeck@kuleuven.be
+3216344580
Backup
Stefan De Smet, PhD
stefan.desmet@kuleuven.be
+32486055917
Time Frame
Start Date: 2022-11-14
Estimated Completion Date: 2029-12
Participants
Target number of participants: 147
Treatments
Sham_comparator: Low intensity training (LIT)
6 months of low-intensity flexibility and balance exercises, not followed by a formal physical activity intervention
Experimental: Moderate-intensity training (MIT)
6 months of exercise intervention (moderate intensity), followed by a co-developed physical activity intervention
Experimental: Moderate- and high-intensity training group (MHIT)
6 months of exercise intervention (moderate-intensity followed by high-intensity), followed by a co-developed physical activity intervention
Related Therapeutic Areas
Sponsors
Collaborators: University Ghent
Leads: KU Leuven

This content was sourced from clinicaltrials.gov