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

ISRCTN ISRCTN65176374
DOI https://doi.org/10.1186/ISRCTN65176374
Secondary identifying numbers 2008010
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

gerard.danjoux@stees.nhs.uk

Study information

Study designMulti-centre, parallel group randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe impact of an aerobic exercise rehabilitation programme on fitness and quality of life in intensive care unit survivors: an exploratory trial
Study objectivesTo 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) studiedQuality of life after ICU admission
InterventionEligible 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 typeOther
Primary outcome measureChanges 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 measuresSecondary 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 study start date01/03/2008
Completion date01/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants64
Key inclusion criteria1. 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 criteria1. 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 enrolment01/03/2008
Date of final enrolment01/03/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cheriton House
Cleveland
TS4 3BW
United Kingdom

Sponsor information

The James Cook University Hospital (UK)
Hospital/treatment centre

Marton Road
Middlesbrough
Cleveland
TS4 3BW
England
United Kingdom

gerard.danjoux@stees.nhs.uk
http://www.southtees.nhs.uk
ROR logo https://ror.org/02vqh3346

Funders

Funder type

Government

National Institute for Health Research (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-04074-13274)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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