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Physical ActivityPHOENIX-KidneyNCT06260579

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

A study testing Exercise/physical activity in people with Physical Activity and Exercise Training, run by KU Leuven at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exercise/physical activity
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
147 participants
Where
2 sitesBelgium
Study dates
14 Nov 2022to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • De novo adult KTRs

Who cannot join

  • 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
Show all 9Show fewer
  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amaryllis Van Craenenbroeck, MD, PhD contact

+3216344580

amaryllis.vancraenenbroeck@kuleuven.be

Stefan De Smet, PhD contact

+32486055917

stefan.desmet@kuleuven.be

Belgium2 sites, 2 recruiting
  • UZ Ghent

    Ghent, 9000

    Calders Patrick, PhD

    Recruiting
  • UZ Leuven

    Leuven, 3000

    Amaryllis Van Craenenbroeck, MD, PhD

    Recruiting

Other trials in Belgium

About this study

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

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.

Read the detailed description

Advances in the field of kidney transplantation have led to improved postoperative survival rates, but age-standardized mortality nonetheless remains two to sevenfold higher in kidney transplant recipients - with cardiovascular disease representing the leading cause of death in recipients with a functioning graft. Poor physical fitness, not completely recovering after transplantation, adds to the heightened cardiovascular risk of hypertension, diabetes, dyslipidaemia, and obesity. So does the posttransplant continuation of gut microbial dysbiosis, which recently emerged as a modulator of muscular, metabolic, and cardiovascular health. Exercise-based rehabilitation and physical activity interventions may prove pivotal in the care of kidney transplant recipients to address aforementioned outcomes.

This multicentre two-phased RCT comprehends a six-month exercise intervention at different exercise intensities, followed by an implementation strategy bundle promoting a physically active lifestyle. A total of 147 adult de novo kidney transplant recipients from two independent Belgian transplant centres will be randomly allocated to either 6 months of home-based exercise training consisting of muscle flexibility and postural stability exercises (low intensity training, LIT, n=49), moderate-intensity aerobic and strength training (moderate intensity training, MIT, n=49), or moderate- and high-intensity aerobic and strength training (moderate- and high-intensity training, MHIT, n=49). MIT will participate in moderate-intensity aerobic training on a stationary bicycle thrice a week and moderate-intensity strength training sessions twice a week. During the initial three months of the exercise intervention MHIT will participate in the same training program as MIT. In the final three months of the training intervention, MHIT will participate in high-intensity aerobic training on a stationary bicycle thrice a week and moderate-intensity strength training twice a week.

Following the six-month exercise training intervention, MIT and MHIT, but not LIT, will receive an individualized activity intervention aiming for long-term physical activity maintenance; using motivational interviewing techniques, co-creation of an action plan adapted to the patients' preferences, goal-setting, gradually decreasing follow-up prompts over time, and self-monitoring of physical activity behaviour. The training and physical activity interventions are initiated 3 and 9 months after transplantation, respectively. Study participants will be followed-up till 2 years after transplantation.

The investigators hypothesize that the study intervention will improve the primary outcome cardiorespiratory fitness, assessed as peak oxygen uptake, at 9 months posttransplant. Secondary outcomes include muscle fitness, motor fitness, body composition, cardiovascular health, gut microbiome characteristics, health-related quality of life, safety, cost-effectiveness, and implementation outcomes at six, nine, 12 and 24 months posttransplant. The role of training intensity and the role of baseline gut microbiome characteristics as predictor of individuals' training response will be explored.

Being tested
Exercise/physical activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise/physical activityBehavioural

    personalized exercise training and physical activity program

Study groups in NCT06260579
Study groupRoleWhat they receive
Low intensity training (LIT)Sham comparator6 months of low-intensity flexibility and balance exercises, not followed by a formal physical activity intervention
Receives: Behavioral: Exercise/physical activity
Moderate-intensity training (MIT)Experimental6 months of exercise intervention (moderate intensity), followed by a co-developed physical activity intervention
Receives: Behavioral: Exercise/physical activity
Moderate- and high-intensity training group (MHIT)Experimental6 months of exercise intervention (moderate-intensity followed by high-intensity), followed by a co-developed physical activity intervention
Receives: Behavioral: Exercise/physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in peak oxygen consumption (VO2peak)

    Assessed by a maximal cardiopulmonary exercise test

    Measured: 6, 12 and 24 months follow-up

Secondary outcomes (1)
  1. Health-related physical fitness

    6 minute walking test

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start14 Nov 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
147 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06260579
Sponsor's protocol ID
S-number 66153
Other IDs
S006722N
Acronym
PHOENIX-Kidney
Status last verified
Feb 2024
First submitted
25 Jan 2024
Last updated
15 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41215780

Questions about this trial

What is this clinical trial studying?

A study testing Exercise/physical activity in people with Physical Activity and Exercise Training, run by KU Leuven at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amaryllis Van Craenenbroeck, MD, PhD (+3216344580, amaryllis.vancraenenbroeck@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in peak oxygen consumption (VO2peak) (time frame: 6, 12 and 24 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06260579, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

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