Condition category
Urological and Genital Diseases
Date applied
31/07/2014
Date assigned
31/07/2014
Last edited
27/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sharlene Greenwood

ORCID ID

Contact details

Denmark Hill
London
SE5 9RS
United Kingdom
-
sharlene.greenwood@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13611

Study information

Scientific title

The effect of resistance training and aerobic exercise on vascular stiffness, novel cardiovascular risk markers, aerobic capacity, muscle strength and incidence of complications in the first year of renal transplantation. A randomised controlled study.

Acronym

ExeRT Trial (EXErcise in Renal Transplant Trial)

Study hypothesis

Physical activity and exercise plays a beneficial role in maintaining the health in those with chronic illnesses however poor physical functioning among patients with chronic kidney disease is well-recognised. The use of modern immunosuppressant therapies have improved the life-expectancy of kidney grafts, however, risks of secondary complications such as diabetes, cardiovascular disease and obesity are an associated risk. It has been established that recipients of kidney transplants increase their physical activity level in the subsequent years after transplantation due to improved quality of life; however within that time they do not reach the level of physical activity of those of age matched healthy controls. Regular aerobic exercise helps to prevent and treat cardiovascular disease and to prevent and reverse arterial stiffening. Resistance training is also an important physical activity that can prevent or treat lifestyle-related diseases. However, high-intensity resistance training reduces arterial compliance and increases arterial stiffness, although this is not a universal finding. That is, regular aerobic exercise increases, whereas high-intensity resistance training decreases arterial compliance. This project will examine the effect and timing of aerobic exercise and resistance training exercise delivered in a 24-week supervised outpatient class setting, on vascular stiffness, aerobic capacity, functional ability, transplant outcomes and quality of life in patients who have received a kidney transplant. The project aims to provide evidence for the importance of exercise for patients that have received a kidney transplant and encourage the commissioning of physiotherapy services for this patient group.

Ethics approval

12/LO/1644

Study design

Randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders

Intervention

Aerobic training: AT will predominantly be on stationary exercise cycles at 80% hear rate reserve.
Resistance Training: Resistance training will use RT machines training large muscle groups (e.g. bench press, latissimus pulldown, bicep curl, triceps pull down,leg press, knee extension, hamstring curl, calf raises). Intensity will be 80% of 1RM, building up to 3 sets of 10 reps.; Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pulse Wave Velocity (PWV); Timepoint(s): Baseline, 12 weeks and 12 months

Secondary outcome measures

1. CVD biomarkers - Fetuin A, TNF receptor 2, IL6, HS CRP; Timepoint(s): Baseline, 12 weeks and 12 months
2. Duke's Activity Status Index; Timepoint(s): Baseline and 12 weeks
3. Muscle strength (myometer); Timepoint(s): baseline and 12 weeks
4. Resting heart rate and blood pressure; Timepoint(s): baseline, 12 weeks and 12 months
5. Sit to stand 60; Timepoint(s): baseline and 12 weeks
6. VO2peak; Timepoint(s): baseline, 12 weeks and 12 months

Overall trial start date

01/03/2013

Overall trial end date

31/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients undergoing renal transplant
2. Male or female
3. Aged >18 years
4. Written informed consent; Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Requiring support for ambulation less than 20m
2. Vasculitis
3. Proliferative diabetic retinopathy,
4. Severe osteodystophy
5. Uncontrolled diabetes
6. Psychiatric illness, including anxiety, mood and untreated eating disorders
7. Infection or course of antibiotics within the last month

Recruitment start date

01/03/2013

Recruitment end date

31/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Foundation Trust (UK)

Sponsor details

Dept of Research & Development KCH
34 Love Walk
London
SE5 8AD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Doctoral Research Fellowship; Grant Codes: NIHR-DRF-2012-05-874

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

The registration of this study was initiated on 22/08/2012, when it was confirmed as proceeding through the NIHR CSP (the system for gaining NHS permission for clinical research). The trialists state that the study details have not been amended in any way since this date. It was confirmed as eligible for inclusion in the UKCRN portfolio on 20/11/2012. The ISRCTN registry received the study for inclusion on the 30/07/2014 and registered the study on 31/07/2014