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.
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
- Conditions the study is for
- Physical Activity, Exercise Training, Kidney Transplantation
- What is being tested?
- Exercise/physical activity
- Type of treatment
- Lifestyle or therapy programme
- 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
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- 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.
Belgium2 sites, 2 recruiting
- Recruiting
UZ Ghent
Ghent, 9000
Calders Patrick, PhD
- Recruiting
UZ Leuven
Leuven, 3000
Amaryllis Van Craenenbroeck, MD, PhD
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.
- Conditions
- Physical Activity, Exercise Training, Kidney Transplantation, Physical Fitness, Cardiovascular Health, Gut Microbiome
- 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 group | Role | What they receive |
|---|---|---|
| Low intensity training (LIT) | Sham comparator | 6 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) | Experimental | 6 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) | Experimental | 6 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.
Changes in peak oxygen consumption (VO2peak)
Assessed by a maximal cardiopulmonary exercise test
Measured: 6, 12 and 24 months follow-up
Secondary outcomes (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.
- First posted15 Feb 2024
- Study start14 Nov 2022
- Primary completion30 Sep 2025 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Principal investigator, Amaryllis Van Craenenbroeck, KU Leuven
- Investigators
- Amaryllis Van Craenenbroeck, MD, PhD, Principal investigator, KU LeuvenPatrick Calders, PhD, Principal investigator, University Ghent
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity - a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06260579
- Acronym / sponsor ID
- PHOENIX-Kidney / S-number 66153
- Conditions
- Physical Activity, Exercise Training, Kidney Transplantation, Physical Fitness, Cardiovascular Health, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Low intensity training (LIT) | Sham comparator | Behavioral: Exercise/physical activity6 months of low-intensity flexibility and balance exercises, not followed by a formal physical activity intervention |
| Moderate-intensity training (MIT) | Experimental | Behavioral: Exercise/physical activity6 months of exercise intervention (moderate intensity), followed by a co-developed physical activity intervention |
| Moderate- and high-intensity training group (MHIT) | Experimental | Behavioral: Exercise/physical activity6 months of exercise intervention (moderate-intensity followed by high-intensity), followed by a co-developed physical activity intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- De novo adult KTRs
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise/physical activitypersonalized exercise training and physical activity program | Behavioural | Low intensity training (LIT), Moderate- and high-intensity training group (MHIT), Moderate-intensity training (MIT) |
Primary outcome
Changes in peak oxygen consumption (VO2peak)
Time frame: 6, 12 and 24 months follow-up
Assessed by a maximal cardiopulmonary exercise test
1 secondary outcome
Health-related physical fitness
Time frame: 3, 6, 9, and 24 months after kidney transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 41215780De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amaryllis Van Craenenbroeck, MD, PhD principal investigator
KU Leuven
Patrick Calders, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
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.