The effect of exercise on patient fitness and quality of life after intensive care admission

ISRCTN	ISRCTN65176374
DOI	https://doi.org/10.1186/ISRCTN65176374
Protocol serial number	2008010
Sponsor	The James Cook University Hospital (UK)
Funder	National Institute for Health Research (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-04074-13274)

Submission date: 02/09/2008
Registration date: 30/09/2008
Last edited: 18/03/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gerard Danjoux
Scientific

Cheriton House
James Cook University Hospital
Marton Road
Middlsbrough
Cleveland
TS4 3BW
United Kingdom

Email	gerard.danjoux@stees.nhs.uk

Study information

Primary study design	Interventional
Study design	Multi-centre, parallel group randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The impact of an aerobic exercise rehabilitation programme on fitness and quality of life in intensive care unit survivors: an exploratory trial
Study objectives	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(s)	Ethics approval received from the Newcastle and North Tyneside 1 Research Ethics Committee on the 16th January 2008 (ref: 07/H0906/137)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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.
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	64
Key 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
Key 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
Date of first enrolment	01/03/2008
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cheriton House

Cleveland
TS4 3BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes