Cardiovascular risk and physical condition in kidney patients

ISRCTN	ISRCTN11615440
DOI	https://doi.org/10.1186/ISRCTN11615440
Secondary identifying numbers	14/EM/1049

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Alice Smith
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
Email	kidney.exercise@uhl-tr.nhs.uk

Study information

Study design	Observational cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not avaliable in web format. Please use contact details below to request a patient 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	1. Physical function: Incremental Shuttle Walking Test (ISWT) and Endurance Shuttle Walking Test (ESWT), Sit-to-stand-5 (STS-5), and STS-60 2. Body composition: anthropometric measures, Bioelectrical Impendence Analysis (BIA), and dual-energy X-ray absorptiometry (DEXA) 3. CVD risk factors: pulse wave velocity, Non-Invasive Cardiac Outcome Measures (NICOM), and systemic inflammatory status 4. Venepuncture for inflammatory and other cardiovascular risk markers 5. General Questionnaires: 5.1. Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue 5.2. Fatigue scales 5.3. European Quality of Life-5 Dimensions (EQ5D) 6. Population-Specific Questionnaires: 6.1. Transplant patients: Kidney Transplant Questionnaire (KTQ) 6.1.1. Leicester Kidney Patient Physical Activity Questionnaire Tx (LKP-PAQ Tx) 6.1.2. Renal Patient Outcome Scale (POS-S Renal plus transplant-specific questions) 6.1.3. Dialysis Patients : Leicester Kidney Patient Physical Activity Questionnaire (LKP-PAQ) 6.1.4. Renal Patient Outcome Scale (POS-S Renal) 6.1.5. Early/Predialysis CKD: Leicester Kidney Patient Physical Activity Questionnaire (LKP-PAQ) 6.1.6. Leicester Kidney Symptom Questionnaire (LKSQ) 6.2. Healthy controls: 6.2.1. Leicester Kidney Patient Physical Activity Questionnaire (LKP-PAQ) 6.2.2. Leicester Kidney Symptom Questionnaire (LKSQ) 7. Habitual physical activity and nutritional intake: accelerometers worn for seven days; food diary completed for 7 days 8. Clinical parameters: (urine sample and fasted blood test). For kidney patients only, co-morbidities and medication details will be extracted from medical records by researchers after visits completed. Note: This is an exploratory observational study investigating relationships between physical activity and functioning, body composition, cardiovascular risk markers and QoL. There is no single primary outcome. Outcome measures measured at a single time point only (cross-sectional study).
Secondary outcome measures	1. Evaluation of the accuracy of BIA vs DEXA in renal transplant patients 2. Evaluation of the accuracy of the self-reported LKP-PAQ questionnaires versus objectively measured physical activity and functioning tests
Overall study start date	23/09/2014
Completion date	31/01/2018

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	60 patients with chronic kidney disease; 10 healthy controls
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

England
United Kingdom

Study participating centre

Leicester General Hospital

Leicester
LE5 4PW
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust
Hospital/treatment centre

Trust HQ
Level 3
Balmoral Building
Leicester Royal Infirmary
Leicester
LE1 5WW
England
United Kingdom

Phone	+44 (0)116 258 4109
Email	RDAdmin@uhhtr.nhs.uk
Website	http://www.leicestershospitals.nhs.uk/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date	02/08/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	We aim to submit the findings from this trial in international peer-reviewed high-impact scientific journals. We will publicise the results in posters and leaflets in clinical areas so patients can read them while they are there, and we will write a report about them in our Kidney Research Newsletter which is freely distributed to our patient population.
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

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.