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Critical illness consequences in terms of daily activity, sleep, exercise capacity, and feeling of fatigue

Anaemia & functional capacity, fatigue, daily activity, sleep, and circadian rhythm disruption among critical illness survivors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN96895644
Enrollment
40
Registered
2022-01-31
Start date
2021-10-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Cardiopulmonary exercise capacity, daily physical activity, quality of sleep, subjective experience of fatigue in critical illness survivors Not Applicable

Interventions

Current interventions as of 02/02/2023: Any time after ICU, all eligible patients will be invited to take part in the study. The consented participants will be subjected to: 1. Wear an accelerometer

Sponsors

University of Edinburgh
Lead Sponsor
NHS Lothian
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 02/02/2023: 1. Patient older than 16 years. 2. Patient who required level 2 or 3 ICU care at any time point during the current hospital admission (defined as advanced respiratory support > 24h and/or at least two organ support) 3. Patient with an appropriate mental capacity to give consent for the study 4. Patient not involved in the post-ICU ABC trial and might have contraindications or objections to blood transfusion 5. Patient enrolled in the restrictive transfusion strategy group of ABC post ICU trial (Haemoglobin concentration at ICU discharge of >94g/L) 6. Patient enrolled in the liberal transfusion strategy group of the ABC post ICU study (Haemoglobin concentration at ICU discharge of >94g/L) _____ Previous inclusion criteria: 1. Patient older than 16 years. 2. Patient who required level 3 ICU care at any time point during the current hospital admission (defined as advanced respiratory support > 48h and/or at least two organ support) 3. Patient with an appropriate mental capacity to give consent for the study 4. Patient not involved in the post-ICU ABC trial and might have contraindication or objections for blood transfusion 5. Patient enrolled in the restrictive transfusion strategy group of ABC post ICU trial (Haemoglobin concentration at ICU discharge of >94g/L) 6. Patient enrolled in the liberal transfusion strategy group of the ABC post ICU study (Haemoglobin concentration at ICU discharge of >94g/L)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 02/02/2023: 1. Active bleeding when screened 2. Primary neurological ICU admission diagnosis 3. Patients discharged from the ICU following cardiac surgery 4. Currently receiving or planned to receive end-of-life care 5. Not expected by a clinical team to survive to hospital discharge. 6. Patient with a proven chronic haematological disease that requires regular RBC transfusion to treat anaemia 7. Patient with dialysis-dependent chronic renal failure prior to ICU admission 8. Patient receiving regular erythropoietin (or any erythropoiesis-stimulating agent) treatment for anaemia prior to ICU admission. 9. Physical condition resulting in an inability to perform a cardiopulmonary exercise test (CPET), for example, major limb trauma, amputation, or primary neurological injury (eg. stroke, brain injury, Guillain-Barre syndrome). 10. Any absolute or relative contraindication for CPET testing. 11. Patient lacking mental capacity at the time of screening for eligibility 12. Patients with a major physical disability that severely affects the activities of daily living before ICU admission _____ Previous exclusion criteria: 1. Active bleeding when screened 2. Primary neurological ICU admission diagnosis 3. Patients discharged from the ICU following cardiac surgery 4. Currently receiving or planned to receive end-of-life care 5. Not expected by a clinical team to survive to hospital discharge. 6. Patient with a proven chronic haematological disease that requires regular RBC transfusion to treat anaemia 7. Patient with dialysis-dependent chronic renal failure prior to ICU admission 8. Patient receiving regular erythropoietin (or any erythropoiesis-stimulating agent) treatment for anaemia prior to ICU admission. 9. Physical condition resulting in an inability to perform a cardiopulmonary exercise test (CPET), for example, major limb trauma, amputation, or primary neurological injury (eg. stroke, brain injury, Guillain-Barre syndrome). 10. Any absolute or relative contraindication for CPET testing. 11. Patient lacking mental capacity at the time of screening for eligibility

Design outcomes

Primary

MeasureTime frame
Feasibility outcomes measured using patient records at the end of the study: 1. Proportion of patients who completed the exercise test 2. Proportion of patients who completed an average duration of useable accelerometer recordings Clinical outcomes: 1. Daily physical activity and quality of sleep variables are measured using a wrist-worn GENEActive accelerometer device for 60 days since enrolment 2. Functional capacity is measured by the bicycle-based cardiopulmonary exercise test (ramp protocol) before hospital discharge 3. Fatigue is measured using a visual analogue scale - fatigue (VAS-F) at enrolment and on the day of exercise test 4. Disability of daily living is measured using Barthel Index (BI) at enrolment and on the day of exercise test

Secondary

MeasureTime frame
1. Causes of exercise limitation among critical illness survivors inferred, based on the exercise test results analysis, and could be either cardiac, pulmonary, muscular, or general deconditioning at the earliest possible time point after ICU discharge 2. Age, gender, haemoglobin (Hb), inflammatory markers (CRP) concentration, and ICU-related factors such as disease severity (APACHE II; SOFA scores), length of mechanical ventilation, length of neuromuscular blocking agent used, total dose of glucocorticosteroids used, measured using patient records at the end of the study

Countries

Scotland, United Kingdom

Outcome results

None listed

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