Quality of life after ICU admission Not Applicable Quality of life
Conditions
Interventions
Eligible patients will be asked to attend for a baseline AT measurement and QoL questionnaires 8 - 16 weeks post-discharge from hospital. Patients will be then be randomised into intervention or contr
age (18 - 39 years versus 40 - 65 years), sex (male versus female), and diagnosis on entry to ICU (sepsis versus trauma). The allocation sequence will be generated and held by a statistician who is no
Sponsors
The James Cook University Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years, either sex 2. Have had a traumatic or primary sepsis event 3. Emergency admission to the ICU 4. Required ventilatory support for a minimum duration of 3 days 5. Must have been discharged home within 6 months of admission 6. Not be currently involved in a rehabilitation programme 7. Must be able to climb a flight of stairs unaided to participate in this study
Exclusion criteria
Exclusion criteria: 1. Lack of consent 2. Aged less than 18 or greater than 65 years 3. Hospitalised greater than 6 months post-ICU discharge 4. Enrolment in current exercise or rehabilitation programme (this includes stroke and cardiac rehabilitation) 5. Inability to climb a flight of stairs 6. Inability to complete the initial cardiopulmonary exercise test 7. Contraindication to cardiopulmonary exercise (CPX) testing Medical exclusions: 1. New York Heart Association functional classification greater than or equal to Class III 2. Canadian Cardiovascular Society Angina Grading Scale greater than or equal to Class III 3. European Society of Hypertension Classification Grades greater than or equal to III 4. Aortic stenosis greater than or equal to moderate (i.e. valve area less than 1.0 cm^2) 5. Hypertrophic cardiomyopathy 6. Symptomatic arrhythmias 7. Severe disability as defined by the Glasgow Outcome Score greater than 2 8. Spinal cord injury 9. Primary muscular disorder (excluding critical illness neuropathy) 10. Uncontrolled epileptic seizures 11. Pregnancy (confirmed with urine sample after consent has been taken) 12. Body mass index (BMI) greater than 40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in AT and quality of life (QoL). QoL will be measured using the SF-36 (Version 2) and EQ-5D questionnaires. The primary outcome will be assessed in intervention and control groups at baseline, week 9 (post 8-week intervention period), and at 26 weeks. The primary comparison is the change in AT and QoL scores from baseline to week 9 (post 8 week exercise program). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome analysis will include: 1. Time of return to work 2. Assessment of mental health (Hospital Anxiety and Depression Scale [HADS] questionnaire) 3. Habitual physical activity outside of (and following) the intervention period. Habitual physical activity will be monitored using a validated self-report instrument. This will be completed after enrolment at baseline, week 9, and at 26 weeks, providing exploratory data for the association between the exercise training and physical activity levels. Other data collection: In addition to the outcome measures above the following data will be collected: 4. Demographic data - age, sex, reason for ICU admission 5. Duration of ICU and hospital stay 6. Medication 7. Time of study enrolment 8. Premorbid quality of life analysis - we accept that this element may be subject to patient recall bias with subjects forgetting their "true" premorbid QoL. Accurate recall may be affected by the ICU experience leading to "over-estimation" of premorbid QoL. | — |
Countries
United Kingdom
Outcome results
None listed