Kidney Transplant; ComplicationsECSERTNCT04123951
Home-based Exercise in Renal Transplant Recipients
A study testing Home-based Exercise in people with Kidney Transplant; Complications, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Although patients who have received a kidney transplant have better health than patients on dialysis, heart problems are still the commonest cause of death for kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Home-based Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2020to 30 Jun 2027
- 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
- Age great than 18 years old
- Prevalent RTR longer than 1year
- Able and willing to give informed consent
- Increased cardiometabolic risk, with at least one of:
- Diabetes mellitus Dyslipidaemia Hypertension History of ischaemic heart disease or cerebrovascular disease Obesity (BMI above 30)
Who cannot join
- Unable to undertake exercise due to physical or psychological barriers
- Unable to undergo CMR scanning (incompatible implants, claustrophobia, allergy to agents)
- Contraindication to exercise training (American College of Sports Medicine guidelines)
- Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- Any other significant disease or disorder (i.e. significant co-morbidity including unstable hypertension, potentially lethal arrhythmia, myocardial infarction within 6 months, unstable angina, active liver disease, uncontrolled diabetes mellitus (HbA1c greater than or equal to 9%), advanced cerebral or peripheral vascular disease) which, in the opinion of the patient's own clinician the Principle Investigator may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Inability to give informed consent or comply with testing and training protocol for any reason.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Leicester NHS Trust
Leicester, Leicestershire, LE5 4PW
About this study
Official title: A Pilot Randomised Controlled Trial of the Effects of a Structured, Home-based Exercise Program on Cardiovascular StructurE and Function in Renal Transplant Recipients: The ECSERT Study
Although patients who have received a kidney transplant have better health than patients on dialysis, heart problems are still the commonest cause of death for kidney transplant recipients. This is because diseases like high blood pressure and diabetes are more common in patients with kidney transplants as well as factors related to having kidney disease itself and the medications transplant recipients have to take to stop them rejecting their transplanted kidney. Exercise is known to help with heart disease in lots of conditions and improves many of the risk factors known to cause heart disease in kidney transplant recipients. This study will investigate whether an individualised, home-based, exercise program improves heart disease in kidney transplant recipients. The study is a randomised controlled trial, with half the patients completing the 12 week exercise programme and the other half continuing with their normal care. The investigators will use detailed MRI scans to assess patient's hearts and blood vessels at the start and end of the study. The investigators will also assess changes in physical function, exercise capacity, blood markers of heart disease, changes in body type and quality of life measures assessed with questionnaires.
Read the detailed description
Kidney transplantation confers a significant survival advantage over remaining on dialysis, but CVD remains the leading cause of death for RTRs and of graft loss. Acute myocardial infarction accounts for 15-20% of CVD-related deaths in RTRs, but sudden cardiac death, or death from fatal arrhythmia account for at least double this number, suggesting classical atheromatous coronary artery disease driven by traditional cardiometabolic risk factors, is not the dominant driving force of CVD in RTRs. Non-traditional cardiometabolic risk factors including endothelial dysfunction, systemic inflammation, acute rejection, anaemia and deranged bone-mineral metabolism are of at least equal importance in the pathogenesis of CVD in RTRs and drive pathological changes in cardiovascular structure and function that associate strongly with mortality. This is further illustrated by the fact that traditional CVD risk-stratification tools dramatically underestimate cardiovascular risk in patients with CKD, coronary revascularization does not improve outcomes for RTRs as it does in the general population and cardiac events are more likely to be fatal in RTRs than the general population. Immunosuppressive agents are well known to drive traditional CVD risk factors, but also drive non-traditional cardiometabolic risk factors. Cost-effective, deliverable interventions are needed to address the burden of CVD in RTRs by targeting traditional and non-traditional risk factors. Supervised exercise interventions in RTRs improve cardiorespiratory fitness and a variety of traditional and non-traditional risk factors for CVD, including metabolic profile, vascular stiffening, central adiposity and inflammatory cell and cytokine profiles, but are not realistically deliverable in the current financial climate. Home-based exercise training programs have been shown to be deliverable in patients on dialysis and patients undergoing cardiac rehabilitation, but the effectiveness and deliverability of home-based exercise interventions are largely untested in RTRs. It cannot be assumed such programs will be acceptable to RTRs, whose home-lives, social and occupational circumstances are significantly different to dialysis and cardiac patients. Many RTRs have had enforced sedentary lifestyles prior to transplantation as dialysis patients and their goals for rehabilitation as well as the disease processes at work are different to both dialysis and cardiac patients.
There are limited data on whether exercise-induced improvements in cardiometabolic risk translate into improvements in cardiovascular structure and function in RTRs. CMR is able to measure multiple clinically pertinent aspects of CVD processes in RTRs that relate closely to outcome with great accuracy, including:
- left ventricular hypertrophy
- myocardial fibrosis
- aortic stiffness
- coronary artery function
- myocardial steatosis
- subclinical systolic and diastolic dysfunction
This pilot randomised clinical trial will assess the deliverability of a combined aerobic and resistance, home-based, exercise intervention in RTRs. It will define recruitment and dropout rates from this newly designed, home-based, intervention and baseline values for CMR measures that assess prognostically important aspects of CVD in RTRs for the first time. Furthermore, it will test the effects of the intervention on traditional and novel CMR outcome measures that assess prognostically important aspects of CVD that relate directly to cardiovascular outcomes for the first time, providing estimates of effect-sizes on outcome measures. These data will be used to inform the design of a future, definitive study. This study will further the investigator's ability to make objective measures of cardiovascular health in RTRs, with the opportunity to compare CMR measures with traditional measures of cardiovascular fitness. The qualitative component of this study will refine the exercise intervention to maximize uptake in future studies and adoption into clinical practice.
- Conditions
- Kidney Transplant; Complications
- Being tested
- Home-based Exercise
- Keywords
- Kidney Transplant, Cardiovascular Disease, Home-based Exercise, Exercise
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based ExerciseOther
Patients in the home-based exercise arm will complete a 12 week home-based aerobic and resistance exercise training programme. There will be a 2 week period prior to this in which patients will complete up to 6 supervised sessions in order to learn about the home-based exercise training. There will be a 4 week return visit and an optional 8 week return visit in order to reassess fitness and aid the patients with any questions or queries they may have and to aid them in progressing their exercise.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Exercise | Experimental | Patients in this arm will complete a 12 week home-based aerobic and resistance exercise training programme. There will be a 2 week period prior to this in which patients will complete up to 6 supervised sessions in order to learn about the home-based exercise training. There will be a 4 week return visit and an optional 8 week return visit in order to reassess fitness and aid the patients with any questions or queries they may have and to aid them in progressing their exercise. Receives: Other: Home-based Exercise |
| Control | No intervention | In this arm patients will continue 'as normal' with daily activities. Patients in this arm will be offered the exercise intervention once they have completed post 12 week assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left ventricular mass (g/m)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in left/right ventricular volumes (ml)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in ejection fractions (%)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in native and post-contrast T1 mapping time (ms)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in Myocardial systolic-strain (%)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in peak early-diastolic strain rate (%s-1)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in Aortic pulse wave velocity (m/s)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in aortic distensibility (mmHg-1×10-3)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Change in Myocardial and hepatic triglyceride content (%)
Measured using multi-parametric cardiac MRI (CMR)
Measured: Baseline and 12 weeks
Secondary outcomes (20)
Recruitment Rate
The feasibility of recruitment and interest of patients is an essential component of whether a full trial is feasible. The number of eligible patients and number of consented will be recorded. Monthly recruitment rate and the time taken to recruit 10 (25%), 20 (50%), 30 (75%), and 40 (100%) patients will be recorded.
Measured: Post 12 week intervention
Number of participants lost to follow up
This is the number of participants leaving the trial due to being uncontactable
Measured: Post 12 week intervention
Number of exercise sessions completed per week
This will assess adherence to the intervention
Measured: Post 12 week intervention
Number of participants dropping out of the trial
Otherwise known as the attrition rate
Measured: Post 12 week intervention
Number of adverse events
This is a measure of the trial safety
Measured: Post 12 week intervention
Aerobic Capacity (change)
Measured by cardiopulmonary exercise test which produces V02 (maximal oxygen uptake) in both l/min and ml/kg/min. This is a measure of a participants aerobic capacity.
Measured: Baseline, 2 weeks, 4 weeks and 12 weeks
Timed up and go test (TUAG)(change)
To determine fall risk and measure the progress of balance, sit to stand and walking. Patient sits and then the time taken to stand up and walk 3 meters and return is measured. If a patient took 14 seconds or longer he or she was classified as high-risk for falling
Measured: Baseline and 12 weeks
Habitual Physical Activity (change)
Via accelerometry
Measured: Baseline and 12 weeks
Lower limb strength (change)
Dynamometry
Measured: Baseline and 12 weeks
Upper Limb Strength (change)
Hand grip
Measured: Baseline and 12 weeks
Change in circulation markers of systemic inflammation
Blood Sampling including but not limited to IL-6, CRP, IL-10, TNF-Alpha
Measured: Baseline and 12 weeks
Muscle quality using Ultrasound Imaging (change)
Cross-sectional area (cm2)
Measured: Baseline and 12 weeks
Muscle quality using Ultrasound Imaging (change)
fat thickness (mm)
Measured: Baseline and 12 weeks
Muscle Elasticity (change)
Muscle elasticity will be measures using a MyotonPro device
Measured: Baseline and 12 weeks
Lower limb endurance (change)
Sit to stand 60 test measuring how many 'sit to stands' can be performed in 60 seconds
Measured: Baseline and 12 weeks
Balance (change)
Measured using a 'wii-fit' style board. Better balance is an idicator of falls risk
Measured: Baseline and 12 weeks
Gait speed (change)
Gait speed is measure as the time taken to walk 4 meters. Slower speeds have been linked to higher mortality risk
Measured: Baseline and 12 weeks
Height
Height measured in meters
Measured: Baseline
Weight (change)
Weight measured in kg
Measured: Baseline and 12 weeks
Body fat % (change)
Body fat measured using bio electrical impedance analysis
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start30 Jan 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Graham-Brown, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123951
- Sponsor's protocol ID
- 0714
- Acronym
- ECSERT
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2019
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Billany RE, Vadaszy N, Burns S, Chowdhury R, Ford EC, Mubaarak Z, Sohansoha GK, Yeo JL, Dattani A, Cowley AC, Gulsin GS, Bishop NC, Smith AC, McCann GP, Graham-Brown MP. Cardiorespiratory fitness in kidney transplant recipients: A pilot randomised controlled trial of structured home-based rehabilitation and a nested case-control analysis. Clin Rehabil. 2026 May;40(5):587-602. doi: 10.1177/02692155251408792. Epub 2025 Dec 30.
PubMed 41468011Billany RE, Macdonald JH, Burns S, Chowdhury R, Ford EC, Mubaarak Z, Sohansoha GK, Vadaszy N, Young HML, Bishop NC, Smith AC, Graham-Brown MPM. A structured, home-based exercise programme in kidney transplant recipients (ECSERT): A randomised controlled feasibility study. PLoS One. 2025 Feb 24;20(2):e0316031. doi: 10.1371/journal.pone.0316031. eCollection 2025.
PubMed 39992959Billany RE, Vadaszy N, Bishop NC, Wilkinson TJ, Adenwalla SF, Robinson KA, Croker K, Brady EM, Wormleighton JV, Parke KS, Cooper NJ, Webster AC, Barratt J, McCann GP, Burton JO, Smith AC, Graham-Brown MP. A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods. BMJ Open. 2021 Oct 5;11(10):e046945. doi: 10.1136/bmjopen-2020-046945.
PubMed 34610929
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial of the Effects of a Structured, Home-based Exercise Program on Cardiovascular StructurE and Function in Renal Transplant Recipients: The ECSERT Study
- ClinicalTrials.gov ID
- NCT04123951
- Acronym / sponsor ID
- ECSERT / 0714
- Conditions
- Kidney Transplant; Complications
- Keywords
- Kidney Transplant, Cardiovascular Disease, Home-based Exercise, Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Oct 2019 (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.
Although patients who have received a kidney transplant have better health than patients on dialysis, heart problems are still the commonest cause of death for kidney transplant recipients. This is because diseases like high blood pressure and diabetes are more common in patients with kidney transplants as well as factors related to having kidney disease itself and the medications transplant recipients have to take to stop them rejecting their transplanted kidney. Exercise is known to help with heart disease in lots of conditions and improves many of the risk factors known to cause heart disease in kidney transplant recipients. This study will investigate whether an individualised, home-based, exercise program improves heart disease in kidney transplant recipients. The study is a randomised controlled trial, with half the patients completing the 12 week exercise programme and the other half continuing with their normal care. The investigators will use detailed MRI scans to assess patient's hearts and blood vessels at the start and end of the study. The investigators will also assess changes in physical function, exercise capacity, blood markers of heart disease, changes in body type and quality of life measures assessed with questionnaires.
Detailed description
Kidney transplantation confers a significant survival advantage over remaining on dialysis, but CVD remains the leading cause of death for RTRs and of graft loss. Acute myocardial infarction accounts for 15-20% of CVD-related deaths in RTRs, but sudden cardiac death, or death from fatal arrhythmia account for at least double this number, suggesting classical atheromatous coronary artery disease driven by traditional cardiometabolic risk factors, is not the dominant driving force of CVD in RTRs. Non-traditional cardiometabolic risk factors including endothelial dysfunction, systemic inflammation, acute rejection, anaemia and deranged bone-mineral metabolism are of at least equal importance in the pathogenesis of CVD in RTRs and drive pathological changes in cardiovascular structure and function that associate strongly with mortality. This is further illustrated by the fact that traditional CVD risk-stratification tools dramatically underestimate cardiovascular risk in patients with CKD, coronary revascularization does not improve outcomes for RTRs as it does in the general population and cardiac events are more likely to be fatal in RTRs than the general population. Immunosuppressive agents are well known to drive traditional CVD risk factors, but also drive non-traditional cardiometabolic risk factors. Cost-effective, deliverable interventions are needed to address the burden of CVD in RTRs by targeting traditional and non-traditional risk factors. Supervised exercise interventions in RTRs improve cardiorespiratory fitness and a variety of traditional and non-traditional risk factors for CVD, including metabolic profile, vascular stiffening, central adiposity and inflammatory cell and cytokine profiles, but are not realistically deliverable in the current financial climate. Home-based exercise training programs have been shown to be deliverable in patients on dialysis and patients undergoing cardiac rehabilitation, but the effectiveness and deliverability of home-based exercise interventions are largely untested in RTRs. It cannot be assumed such programs will be acceptable to RTRs, whose home-lives, social and occupational circumstances are significantly different to dialysis and cardiac patients. Many RTRs have had enforced sedentary lifestyles prior to transplantation as dialysis patients and their goals for rehabilitation as well as the disease processes at work are different to both dialysis and cardiac patients.
There are limited data on whether exercise-induced improvements in cardiometabolic risk translate into improvements in cardiovascular structure and function in RTRs. CMR is able to measure multiple clinically pertinent aspects of CVD processes in RTRs that relate closely to outcome with great accuracy, including:
- left ventricular hypertrophy
- myocardial fibrosis
- aortic stiffness
- coronary artery function
- myocardial steatosis
- subclinical systolic and diastolic dysfunction
This pilot randomised clinical trial will assess the deliverability of a combined aerobic and resistance, home-based, exercise intervention in RTRs. It will define recruitment and dropout rates from this newly designed, home-based, intervention and baseline values for CMR measures that assess prognostically important aspects of CVD in RTRs for the first time. Furthermore, it will test the effects of the intervention on traditional and novel CMR outcome measures that assess prognostically important aspects of CVD that relate directly to cardiovascular outcomes for the first time, providing estimates of effect-sizes on outcome measures. These data will be used to inform the design of a future, definitive study. This study will further the investigator's ability to make objective measures of cardiovascular health in RTRs, with the opportunity to compare CMR measures with traditional measures of cardiovascular fitness. The qualitative component of this study will refine the exercise intervention to maximize uptake in future studies and adoption into clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Exercise | Experimental | Other: Home-based ExercisePatients in this arm will complete a 12 week home-based aerobic and resistance exercise training programme. There will be a 2 week period prior to this in which patients will complete up to 6 supervised sessions in order to learn about the home-based exercise training. There will be a 4 week return visit and an optional 8 week return visit in order to reassess fitness and aid the patients with any questions or queries they may have and to aid them in progressing their exercise. |
| Control | No intervention | –In this arm patients will continue 'as normal' with daily activities. Patients in this arm will be offered the exercise intervention once they have completed post 12 week assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age great than 18 years old
- Prevalent RTR longer than 1year
- Able and willing to give informed consent
- Increased cardiometabolic risk, with at least one of:
- Diabetes mellitus Dyslipidaemia Hypertension History of ischaemic heart disease or cerebrovascular disease Obesity (BMI above 30)
Key exclusion criteria (7 listed)
- Unable to undertake exercise due to physical or psychological barriers
- Unable to undergo CMR scanning (incompatible implants, claustrophobia, allergy to agents)
- Contraindication to exercise training (American College of Sports Medicine guidelines)
- Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
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 |
|---|---|---|
| Home-based ExercisePatients in the home-based exercise arm will complete a 12 week home-based aerobic and resistance exercise training programme. There will be a 2 week period prior to this in which patients will complete up to 6 supervised sessions in order to learn about the home-based exercise training. There will be a 4 week return visit and an optional 8 week return visit in order to reassess fitness and aid the patients with any questions or queries they may have and to aid them in progressing their exercise. | Other | Home-based Exercise |
Primary outcome
Change in Left ventricular mass (g/m)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in left/right ventricular volumes (ml)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in ejection fractions (%)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in native and post-contrast T1 mapping time (ms)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in Myocardial systolic-strain (%)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in peak early-diastolic strain rate (%s-1)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in Aortic pulse wave velocity (m/s)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in aortic distensibility (mmHg-1×10-3)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
Change in Myocardial and hepatic triglyceride content (%)
Time frame: Baseline and 12 weeks
Measured using multi-parametric cardiac MRI (CMR)
20 secondary outcomes
Recruitment Rate
Time frame: Post 12 week intervention
Number of participants lost to follow up
Time frame: Post 12 week intervention
Number of exercise sessions completed per week
Time frame: Post 12 week intervention
Number of participants dropping out of the trial
Time frame: Post 12 week intervention
Number of adverse events
Time frame: Post 12 week intervention
Aerobic Capacity (change)
Time frame: Baseline, 2 weeks, 4 weeks and 12 weeks
Timed up and go test (TUAG)(change)
Time frame: Baseline and 12 weeks
Habitual Physical Activity (change)
Time frame: Baseline and 12 weeks
Lower limb strength (change)
Time frame: Baseline and 12 weeks
Upper Limb Strength (change)
Time frame: Baseline and 12 weeks
Change in circulation markers of systemic inflammation
Time frame: Baseline and 12 weeks
Muscle quality using Ultrasound Imaging (change)
Time frame: Baseline and 12 weeks
Muscle quality using Ultrasound Imaging (change)
Time frame: Baseline and 12 weeks
Muscle Elasticity (change)
Time frame: Baseline and 12 weeks
Lower limb endurance (change)
Time frame: Baseline and 12 weeks
Balance (change)
Time frame: Baseline and 12 weeks
Gait speed (change)
Time frame: Baseline and 12 weeks
Height
Time frame: Baseline
Weight (change)
Time frame: Baseline and 12 weeks
Body fat % (change)
Time frame: Baseline and 12 weeks
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 30 Apr 2026.
- Derived from this study: PubMed 41468011Billany RE, Vadaszy N, Burns S, Chowdhury R, Ford EC, Mubaarak Z, Sohansoha GK, Yeo JL, Dattani A, Cowley AC, Gulsin GS, Bishop NC, Smith AC, McCann GP, Graham-Brown MP. Cardiorespiratory fitness in kidney transplant recipients: A pilot randomised controlled trial of structured home-based rehabilitation and a nested case-control analysis. Clin Rehabil. 2026 May;40(5):587-602. doi: 10.1177/02692155251408792. Epub 2025 Dec 30.
- Derived from this study: PubMed 39992959Billany RE, Macdonald JH, Burns S, Chowdhury R, Ford EC, Mubaarak Z, Sohansoha GK, Vadaszy N, Young HML, Bishop NC, Smith AC, Graham-Brown MPM. A structured, home-based exercise programme in kidney transplant recipients (ECSERT): A randomised controlled feasibility study. PLoS One. 2025 Feb 24;20(2):e0316031. doi: 10.1371/journal.pone.0316031. eCollection 2025.
- Derived from this study: PubMed 34610929Billany RE, Vadaszy N, Bishop NC, Wilkinson TJ, Adenwalla SF, Robinson KA, Croker K, Brady EM, Wormleighton JV, Parke KS, Cooper NJ, Webster AC, Barratt J, McCann GP, Burton JO, Smith AC, Graham-Brown MP. A pilot randomised controlled trial of a structured, home-based exercise programme on cardiovascular structure and function in kidney transplant recipients: the ECSERT study design and methods. BMJ Open. 2021 Oct 5;11(10):e046945. doi: 10.1136/bmjopen-2020-046945.
- 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. This study is not recruiting at the moment.
Matthew Graham-Brown principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise in people with Kidney Transplant; Complications, run by University of Leicester at 1 site in United Kingdom.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left ventricular mass (g/m) (time frame: Baseline and 12 weeks). The study lists 9 primary outcomes in all. 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 NCT04123951, which also lists 3 linked publications.
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 30 Apr 2026.