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
| ISRCTN | ISRCTN43892586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43892586 |
| Secondary identifying numbers | 13611 |
- Submission date
- 31/07/2014
- Registration date
- 31/07/2014
- Last edited
- 06/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Sharlene Greenwood
Scientific
Scientific
Denmark Hill
London
SE5 9RS
United Kingdom
| sharlene.greenwood@nhs.net |
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | ExeRT Trial (EXErcise in Renal Transplant Trial) |
| Study objectives | 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(s) | 12/LO/1644 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2013 |
| Completion date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 31/10/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Denmark Hill
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
King's College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Dept of Research & Development KCH
34 Love Walk
London
SE5 8AD
England
United Kingdom
"ROR" |
https://ror.org/01n0k5m85 |
|---|
Funders
Funder type
Government
NIHR Doctoral Research Fellowship; Grant Codes: NIHR-DRF-2012-05-874
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/02/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
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.
06/02/2017: Publication reference added.
