Contact information
Type
Scientific
Primary contact
Dr Gerard Danjoux
ORCID ID
Contact details
Cheriton House
James Cook University Hospital
Marton Road
Middlsbrough
Cleveland
TS4 3BW
United Kingdom
gerard.danjoux@stees.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2008010
Study information
Scientific title
The impact of an aerobic exercise rehabilitation programme on fitness and quality of life in intensive care unit survivors: an exploratory trial
Acronym
Study hypothesis
To evaluate the effect of an 8-week supervised exercise programme on patient fitness (as judged by AT [anaerobic threshold] measurement) and quality of life (as judged by 36-item short form health survey [SF-36] and Euroqol EQ-5D), following critical illness and discharge from intensive care unit (ICU).
Ethics approval
Ethics approval received from the Newcastle and North Tyneside 1 Research Ethics Committee on the 16th January 2008 (ref: 07/H0906/137)
Study design
Multi-centre, parallel group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Quality of life after ICU admission
Intervention
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 control groups. The 'usual care' group will be the control.
We have elected to adapt the process of simple random allocation of subjects to groups by using a minimisation method. Minimisation will be performed using Minim software. Initially, a permuted block design (1:1 ratio) will be employed with block sizes of 2, 4, and 6 selected at random. Thereafter, minimisation will be incorporated to ensure a good balance between trial arms. We intend to minimise on three factors; 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 not involved in enrolment or assessment of outcomes, and will be concealed from the investigators until baseline AT has been measured and baseline questionnaires completed.
The patients in the intervention group will be required to perform a 40 minute exercise session, twice a week for 8 weeks under supervision by trained staff with resuscitation equipment available. and one unsupervised session per week (brisk 40 minute walk). All exercise sessions will be of appropriate intensity and duration to provide a sufficient exercise challenge to test our hypothesis.
All patients will be asked to return at week 9 to retest their AT measurement as well as complete the four questionnaires. This will also be repeated at week 26 of the study for both arms. Patients allocated to the control groups will be seen at weeks 0, 9 and 26 for AT measurement and completion of questionnaires.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/03/2008
Overall trial end date
01/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64
Participant 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
Recruitment start date
01/03/2008
Recruitment end date
01/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cheriton House
Cleveland
TS4 3BW
United Kingdom
Sponsor information
Organisation
The James Cook University Hospital (UK)
Sponsor details
Marton Road
Middlesbrough
Cleveland
TS4 3BW
United Kingdom
gerard.danjoux@stees.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-04074-13274)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24607602
Publication citations
-
Results
Batterham AM, Bonner S, Wright J, Howell SJ, Hugill K, Danjoux G, Effect of supervised aerobic exercise rehabilitation on physical fitness and quality-of-life in survivors of critical illness: an exploratory minimized controlled trial (PIX study)., Br J Anaesth, 2014, 113, 1, 130-137, doi: 10.1093/bja/aeu051.