Condition category
Not Applicable
Date applied
02/09/2008
Date assigned
30/09/2008
Last edited
18/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.southtees.nhs.uk

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24607602

Publication citations

  1. 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.

Additional files

Editorial Notes