Cardiovascular risk and physical condition in kidney patients

COCO: CardiOvascular risk factors and physical COndition in kidney patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11615440

Enrollment

Registered

2016-01-22

Start date

2014-09-23

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Established chronic kidney disease (all stages are eligible including those on dialysis or with an established kidney transplant) Urological and Genital Diseases Chronic kidney disease

Interventions

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 additional

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 complete	—

Measure

Time frame

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 complete

—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026