Does a six week supervised Exercise programme improve fitness and well-being in Post Intensive Care patients? (EPIC)
| ISRCTN | ISRCTN11853373 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11853373 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/11/2011
- Registration date
- 07/02/2012
- Last edited
- 12/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There is a lot of research that tells us that people who have been in the Intensive Care Unit (ICU) in hospital can often (but not always) experience ongoing problems such as loss of general fitness, balance and strength, or experience higher levels of anxiety and depression. Our study aims to investigate whether a six-week exercise programme can improve any of these possible difficulties experienced by patients who have been discharged home from hospital, after having been in the ICU for more than 48 hours.
Who can participate?
Patients aged 18 or over who have been in the ICU for longer than 48 hours.
What does the study involve?
The study involves attending the physiotherapy department in Morriston Hospital for about 30 minutes, where the patient will carry out three simple fitness tests and complete a short questionnaire. The fitness tests include the Six Minute Walk Test which involves walking for six minutes if the patient is able, a series of simple balance exercises and a test where the patient squeezes their hands into a fist as tight as possible to measure grip strength. Following these tests, the patients will be randomly allocated to either the control group or the exercise group. The control group will be given a general advice sheet on exercise and will then re-attend the physiotherapy department seven weeks later to complete the same series of tests. The exercise group will be asked to attend the physiotherapy gym in Morriston Hospital twice a week for six weeks where they will carry out an exercise programme with a physiotherapist either on their own or with one other patient. The programme will include exercises such as using the treadmill, rowing machine, static bike or stepper and simple strengthening and balance exercises. These sessions will last between 40 minutes and one hour. At the end of the six weeks, the patient will complete the same series of tests that were completed at the start of the programme. Both groups of patients will be asked to complete the tests at 6 months and one year after the study in order to assess any longer lasting benefits of the programme.
What are the possible benefits and risks of participating?
There are no risks associated with this study. The patient may feel slight muscle soreness the day after they have exercised but they will be warmed up and cooled down properly in order to minimise this risk.
Where is the study run from?
Morriston Hospital (UK).
When is the study starting and how long is it expected to run for?
November 2011 to October 2013.
Who is funding the study?
This study is receiving no funding from any external source. The ICU physiotherapy team are completing the study as part of their normal daily work.
Who is the main contact?
Miss Ceri Battle
Ceri.Battle@wales.nhs.uk
Contact information
Scientific
Physiotherapy Department
Morriston Hospital
Morriston
Swansea
SA6 6NL
United Kingdom
 ORCID ID |
0000-0002-7503-1931 |
|---|---|
| Phone | +44 (0)1792 703124 |
| Ceri.Battle@wales.nhs.uk |
Study information
| Study design | Single-centre pragmatic blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial examining the effect of a six week supervised exercise programme on patient fitness and hospital related anxiety and depression following an intensive care length of stay of greater than 48 hours |
| Study acronym | EPIC |
| Study objectives | 1. What is the impact of a six week supervised exercise programme on cardiopulmonary fitness in patients who have been discharged home from hospital following an intensive care unit (ICU) length of stay of greater than 48 hours? 2. What is the impact of a six week supervised exercise programme on balance, muscle strength, anxiety and depression levels in patients who have been discharged home from hospital following an ICU length of stay of greater than 48 hours? 3. What is the impact of a six week supervised exercise programme on mortality, return to work and primary and secondary care utilisation at six month and one year follow up? |
| Ethics approval(s) | South West Wales Research and Ethics Committee, October 2011, ref: 11/WA/0216 |
| Health condition(s) or problem(s) studied | Any patient who has been a patient on ICU (general) for 48 hours or more |
| Intervention | Six week, twice weekly, supervised exercise programme which includes: 1. Cardiovascular exercise on treadmill, cycle ergometer, rowing machine and stepper 2. Balance exercises 3. Strengthening exercises Control group: No treatment Tested at baseline, 7 weeks, 6 months and 1 year. |
| Intervention type | Behavioural |
| Primary outcome measure | Cardiopulmonary fitness: Six minute walk test (Guyatt et al 1985) |
| Secondary outcome measures | 1. Balance: measured by the Berg Balance Score (Berg et al 1989) 2. Grip strength as measured by JAMAR grip dynamometer 3. Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (Zigmond and Snaith 1983) |
| Overall study start date | 01/07/2011 |
| Completion date | 30/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 patients |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Male or female patients who are aged 18 years or more (no upper age limit) 2. Patients who have had a length of stay on ICU for more than 48 hours 3. Patients who have been discharged home and are attending follow up clinic within 6 months of their discharge from ICU 4. Patients who can follow instructions 5. Patients who are not already enrolled in a rehabilitation programme 6. Patients who live within commutable distance |
| Key exclusion criteria | 1. Patients who do not consent to participation in the study 2. Patients aged less than 18 years 3. Patients hospitalised for longer than 6 months since their discharge from ICU 4. Patients who lack capacity to follow instructions 5. Patients who are already enrolled in a rehabilitation programme 6. Patients who live outside of commutable distance 7. Patients with any medical contraindications to exercise, including: 7.1. Unstable angina or myocardial infarction in the preceding month 7.2. Unmanaged valvular problems 7.3. Patients awaiting further definitive treatment (e.g. open abdominal wound) 7.4. Pregnancy where the patient has been advised against exercise |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 30/03/2015 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Swansea
SA6 6NL
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Morriston Hospital
Morriston
Swansea
SA6 6NL
Wales
United Kingdom
| Website | http://www.wales.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04zet5t12 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish our trial in an international peer-reviewed journal by the end of 2018. Preliminary results have been presented at ICS State of the Art Winter Meeting in December 2017. Other documents are available on request by individuals from Ceri Battle on ceri.battle@Wales.nhs.uk |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Ceri Battle on ceri.battle@wales.nhs.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2019 | 12/06/2019 | Yes | No |
Editorial Notes
12/06/2019: Publication reference and total final enrolment number added.
11/01/2018: This trial is completed and is currently under review for publication. The overall trial dates have been updated from 01/11/2011-31/10/2013 to 01/07/2011-30/08/2017. The recruitment end date has been updated from 31/10/2013 to 30/03/2015. The publication and dissemination plans have been updated. The participant level data sharing statement has been added. The ORCID has been added for the study contact.
