Cardiovascular risk and physical condition in kidney patients
| ISRCTN | ISRCTN11615440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11615440 |
| Protocol serial number | 14/EM/1049 |
| Sponsor | University Hospitals of Leicester NHS Trust |
| Funder | Self-funded. This is a single-centre study funded by a £1.5m grant awarded to Dr Alice Smith by an anonymous private charitable trust |
- Submission date
- 27/10/2015
- Registration date
- 22/01/2016
- Last edited
- 10/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
People with kidney problems often suffer from poor quality of life and many health problems. For example, kidney disease patients are more likely to develop heart disease, and many of them find that their muscles become weak and they feel very tired. Having a kidney transplant can transform the life of someone whose kidneys have failed through disease. However, the new kidney does not usually work as well as those of a healthy person and transplant patients can still suffer from a variety of health problems. They also have to take drugs to prevent their immune system rejecting the new kidney, which can cause side effects. We all know that exercise is good for us. In healthy people it improves the health of the heart and strengthens the muscles. Therefore, exercise might be able to help people with kidney disease too, but there has not yet been much research to study this. Before we carry out research to see how exercise might benefit kidney patients, we first need to find out about their current activity levels, their physical fitness, and how this relates to any health problems they might have. We also need to compare them to healthy people to assess what effects the kidney problem is having.
Who can participate?
People aged over 18 with kidney disease and healthy people of the same age and sex
What does the study involve?
Participants are invited to the hospital for a series of tests to measure their fitness, their heart health and how much body fat and muscle they have. They are asked to fill in some questionnaires about their quality of life and their health problems and symptoms, and we will give them a small activity monitor to wear for a week to measure how active they are.
What are the possible benefits and risks of participating?
The results of this study will give us important new information which will help us design exercise programmes suitable for the needs of kidney patients. In the future we will do more research to test how these exercise programmes might help people with kidney disease to enjoy a more active and healthy lifestyle. There are limited risks in taking part in this study. Blood samples taken during the study may cause slight discomfort or pain and bruising to the arm afterwards. Further, these blood tests are taken in a “fasted” state (i.e. no food or drink (apart from water) since the previous evening). Participant’s body composition in the study is assessed using a DEXA scan, a type of X-ray. A DEXA scan involves a low dose of radiation, but the dose is small and equal to about 10 days of normal background radiation. The functional tests performed in the study (i.e. shuttle walk tests, sit to stand tests) are associated with a low risk of accident or injury (as with all physical activity). However, these tests have been routinely used by our group and are well tolerated in kidney patients. All tests will be carried out by trained researchers in a hospital setting with resuscitation facilities available. Overall, the main disadvantage of taking part is the time commitment involved in the hospital visits for assessments (2 or 3 visits in total), although travel expenses and car parking will be reimbursed. Whilst straightforward to answer, the pack of questionnaires participants are required to fill in can take upwards of 1 hour to complete
Where is the study run from?
Leicester General Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2014 to January 2018
Who is funding the study?
Private Charitable Trust
Who is the main contact?
Prof. Alice Smith
kidney.exercise@uhl-tr.nhs.uk
Contact information
Scientific
Leicester Kidney Exercise Team
Academic Unit
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
 ORCID ID |
0000-0002-9234-9060 |
|---|---|
| Phone | +44 (0)116 258 4346 |
| kidney.exercise@uhl-tr.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | COCO: CardiOvascular risk factors and physical COndition in kidney patients |
| Study acronym | COCO |
| Study objectives | An exploratory observational study designed to collect data to inform the subsequent design of a realistic and effective exercise programme suited to the needs of this population, and research studies to evaluate its ability to positively impact upon important health issues in kidney patients. It is based at University Hospitals of Leicester. We hypothesise that low levels of physical activity and physical functioning are associated with unfavourable body composition (lower muscle mass and higher fat mass), increased cardiovascular risk, and poorer quality of life in kidney patients. |
| Ethics approval(s) | NHS Research Ethics Committee East Midlands (Derby), 21/07/2014, ref: 14/EM/1049 |
| Health condition(s) or problem(s) studied | Established chronic kidney disease (all stages are eligible including those on dialysis or with an established kidney transplant) |
| Intervention | This project will use a combination of subjective and objective measures to explore exercise capacity and habitual physical activity levels in kidney patients and healthy controls, and will additionally collect data on clinical parameters, body composition, cardiovascular risk, central haemodynamics and quality of life. This is an exploratory observational study designed to collect data to inform the subsequent design of a realistic and effective exercise programme suited to the needs of this population, and research studies to evaluate its ability to positively impact upon important health issues in kidney patients. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Physical function: Incremental Shuttle Walking Test (ISWT) and Endurance Shuttle Walking Test (ESWT), Sit-to-stand-5 (STS-5), and STS-60 |
| Key secondary outcome measure(s) |
1. Evaluation of the accuracy of BIA vs DEXA in renal transplant patients |
| Completion date | 31/01/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 70 |
| Total final enrolment | 106 |
| Key inclusion criteria | 1. Patients with established chronic kidney disease (all stages are eligible including those on dialysis or with an established kidney transplant) 2. Healthy control participants |
| Key exclusion criteria | 1. Age <18 years 2. Pregnancy 3. Any element of study assessment protocol considered by own clinician to be contraindicated due to physical impairment, comorbidity or any other reason 4. Visual or hearing impairment or insufficient command of English to give informed consent or comply with the assessment protocol 5. Inability to give informed consent for any reason |
| Date of first enrolment | 23/09/2014 |
| Date of final enrolment | 02/08/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
LE5 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2019 | 10/09/2019 | Yes | No |
| Results article | results | 01/08/2019 | 10/09/2019 | Yes | No |
| Results article | results | 01/01/2019 | 10/09/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/09/2019: The following changes were made to the trial record:
1. Publication references and total final enrolment added.
2. The overall trial end date was changed from 02/08/2019 to 31/01/2018.
31/10/2017: Internal review.
