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

NCT06260579 | Recruiting

• 2 other identifiers: S-number 66153S006722N
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in peak oxygen consumption (VO2peak)

  Assessed by a maximal cardiopulmonary exercise test

  6, 12 and 24 months follow-up

Secondary Outcomes (1)

• Health-related physical fitness

  3, 6, 9, and 24 months after kidney transplantation

Study Arms (3)

Low intensity training (LIT)

SHAM COMPARATOR

6 months of low-intensity flexibility and balance exercises, not followed by a formal physical activity intervention

Behavioral: Exercise/physical activity

Moderate-intensity training (MIT)

EXPERIMENTAL

6 months of exercise intervention (moderate intensity), followed by a co-developed physical activity intervention

Behavioral: Exercise/physical activity

Moderate- and high-intensity training group (MHIT)

EXPERIMENTAL

6 months of exercise intervention (moderate-intensity followed by high-intensity), followed by a co-developed physical activity intervention

Behavioral: Exercise/physical activity

Interventions

Exercise/physical activity BEHAVIORAL

personalized exercise training and physical activity program

Low intensity training (LIT); Moderate- and high-intensity training group (MHIT); Moderate-intensity training (MIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• De novo adult KTRs

You may not qualify if:

• 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).

Sponsors & Collaborators

• KU Leuven: lead
• University Ghent: collaborator

Study Sites (2)

UZ Ghent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

• De Smet S, Vandecruys M, De Beir J, Leunis S, Wyngaert KV, Renier M, de Loor H, Goetschalckx K, Naesens M, De Smedt D, Verbeke F, Stalmans I, Fieuws S, Glorieux G, Van Eijgen J, Van Criekinge H, Raes J, De Geest S, Van Biesen W, Kuypers D, Nagler E, Calders P, Monbaliu D, Cornelissen V, Van Craenenbroeck AH. Home-based exercise and physical activity intervention after kidney transplantation: impact of exercise intensity (PHOENIX-Kidney). Protocol for a multicentre randomized controlled trial. Clin Kidney J. 2025 Apr 24;18(11):sfaf114. doi: 10.1093/ckj/sfaf114. eCollection 2025 Nov.

  PMID: 41215780 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amaryllis Van Craenenbroeck, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Patrick Calders, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amaryllis Van Craenenbroeck, MD, PhD

CONTACT

+3216344580; amaryllis.vancraenenbroeck@kuleuven.be

Stefan De Smet, PhD

CONTACT

+32486055917; stefan.desmet@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to the group allocation of the patients. Due to the nature of the intervention, blinding of the patients is not possible. However, a sham training intervention is provided to the control group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel group randomized controlled trial

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 15, 2024
• Study Start: November 14, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)