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
Not available in web format, please use contact details to request a participant 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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28158243