Home-based Exercise in Renal Transplant Recipients

NCT04123951 | Active Not Recruiting DMC

• 1 other identifier: 0714
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Transplant; Complications

Keywords

Kidney Transplant; Cardiovascular Disease; Home-based Exercise; Exercise

Outcome Measures

Primary Outcomes (9)

• Change in Left ventricular mass (g/m)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in left/right ventricular volumes (ml)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in ejection fractions (%)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in native and post-contrast T1 mapping time (ms)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in Myocardial systolic-strain (%)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in peak early-diastolic strain rate (%s-1)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in Aortic pulse wave velocity (m/s)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in aortic distensibility (mmHg-1×10-3)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

• Change in Myocardial and hepatic triglyceride content (%)

  Measured using multi-parametric cardiac MRI (CMR)

  Baseline and 12 weeks

Secondary Outcomes (20)

• Recruitment Rate

  Post 12 week intervention

• Number of participants lost to follow up

  Post 12 week intervention

• Number of exercise sessions completed per week

  Post 12 week intervention

• Number of participants dropping out of the trial

  Post 12 week intervention

• Number of adverse events

  Post 12 week intervention

Other Outcomes (5)

• Integrated Palliative care Outcome Scale for Renal (I-POS-Renal)(change)

  Baseline and 12 weeks

• Short Form Health Survey (SF-12)(change)

  Baseline and 12 weeks

• Patient Activation Measure (PAM)(Change)

  Baseline and 12 weeks

Study Arms (2)

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.

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.

Interventions

Home-based Exercise OTHER

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.

Home-based Exercise

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University Hospital Leicester NHS Trust

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 41468011 DERIVED

• Billany 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.

  PMID: 39992959 DERIVED

• Billany 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.

  PMID: 34610929 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Matthew Graham-Brown

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: October 11, 2019
• Study Start: January 30, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)