Musculoskeletal problems following critical illness
| ISRCTN | ISRCTN24998809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24998809 |
| IRAS number | 296030 |
| Secondary identifying numbers | CPMS 50989, IRAS 296030 |
- Submission date
- 31/12/2021
- Registration date
- 21/03/2022
- Last edited
- 25/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The intensive care unit (ICU) is a vital part of hospital care, with more patients requiring treatment in the ICU each year. However, patients who survive ICU often experience long-term physical problems resulting in a poor quality of life. There have been several studies investigating rehabilitation after ICU. These have demonstrated little benefit on physical function, exercise capacity or quality of life. Musculoskeletal (MSK) problems are those that affect bone, muscle and joints. MSK problems affect 25% of the UK population and limit people’s ability to work. To date, there has been a small amount of research that has shown that ICU survivors are likely to experience MSK problems that would potentially benefit from physiotherapy. The aim of this study is to evaluate the overall MSK health of patients, 6 months after they were admitted to ICU.
Who can participate?
Adult patients who have spent more than 2 days in the ICU
What does the study involve?
The participants will be phoned 6 months after they were admitted to the ICU and will be asked several questionnaires. These questionnaires will gather information on their MSK health, employment and quality of life. Participants who report a MSK problem during the telephone conversation will be invited to have one of two assessments visits. One group of patients will undergo a full MSK assessment with a physiotherapist. This will include pain, muscle and joint assessment. A smaller group of patients with severe MSK problems will undergo the same MSK assessment as above plus some additional tests which will be performed at Oxford Brookes University. They will be asked about their function, have an ultrasound scan, undertake a walking test and be given a wristband to record how active they are for a week after their visit.
What are the possible benefits and risks of participating?
As this research is focused on using information, some of which is already routinely collected, so the risk of harm is very low. Questionnaires assessing the symptoms of participants used at the telephone follow-up do assess symptoms that may cause mild distress to participants. If this occurs, participants will be offered advice on avenues for support such as ICU support groups, and any clinically concerning information that is reported by participants at any point will be discussed with their GP.
Participants may experience discomfort or pain as part of the assessment process, which is common during any musculoskeletal assessment and will be minimised by the research team. The researchers do not promise the study will help participants in particular, but the information they get from this study may help improve the NHS treatment for people recovering from critical illness in the future.
Where is the study run from?
Oxford University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
June 2018 to June 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Mr Owen Gustafson
owen.gustafson@ouh.nhs.uk
Contact information
Scientific
Therapies Clinical Service Unit
Physiotherapy Department
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0002-5450-3696 |
|---|---|
| Phone | +44 (0)1865 221543 |
| owen.gustafson@ouh.nhs.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluating the musculoskeletal health state of intensive care unit survivors: a multicentre observational study |
| Study acronym | MSK-ICU |
| Study objectives | To determine and characterise the musculoskeletal (MSK) health state of intensive care unit survivors 6 months following admission to intensive care, in order to inform future development of targeted rehabilitation interventions. |
| Ethics approval(s) | Approved 16/11/2021, North of Scotland Ethics Committee 2 (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; gram.nosres@nhs.scot), REC ref: 21/NS/0143 |
| Health condition(s) or problem(s) studied | Musculoskeletal health state of intensive care unit survivors |
| Intervention | In this observational study, the researchers will recruit 322 adult patients who have spent more than 2 days in the ICU and follow these patients up by telephone questionnaire 6 months following their admission to ICU. The researchers believe that following an admission to ICU, patients may be experiencing musculoskeletal problems that are contributing to poor physical function. They will evaluate patients musculoskeletal health state and identify and factors associated with poor musculoskeletal health after critical illness. |
| Intervention type | Other |
| Primary outcome measure | Musculoskeletal health state measured using the Musculoskeletal Health Questionnaire (MSK-HQ) at 6 months |
| Secondary outcome measures | Measured at 6 months: 1. Health-related quality of life measured using the EuroQol 5D (EQ-5D) 2. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) 3. Subjective distress measured using the Impact of Events Scale-Revised (IES-R) 4. Employment measured using an employment questionnaire |
| Overall study start date | 01/06/2018 |
| Completion date | 26/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 332; UK Sample Size: 332 |
| Total final enrolment | 334 |
| Key inclusion criteria | Patients who have been admitted to ICU for 48 hours or more |
| Key exclusion criteria | 1. Patients who are judged to lack capacity at the time of consent as defined by the Mental Capacity Act (2005) 2. Proven or suspected acute primary brain pathology, spinal cord injury or other neuromuscular disease resulting in proven or prolonged weakness 3. Admitted to the intensive care unit with musculoskeletal complications or trauma 4. Patients who were dependent for activities of daily living in the month prior to current intensive care unit admission (gait aids are acceptable) 5. Patients who have a palliative diagnosis/treatment pathway 6. Prisoners 7. Patients with no fixed abode 8. Patients who are unable to communicate clearly in English over the telephone for 20 minutes 9. Patients refusing consent |
| Date of first enrolment | 23/02/2022 |
| Date of final enrolment | 02/01/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Headington
Oxford
OX3 9DU
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Marlborough Road
Swindon
SN3 6BB
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Joint Research Office
Second Floor
OUH Cowley
Unipart House Business Centre
Garsington Road
Oxford
OX4 2PG
England
United Kingdom
| Phone | +44 (0)1865 223714 |
|---|---|
| ouh.sponsorship@ouh.nhs.uk | |
| Website | http://www.ouh.nhs.uk/ |
"ROR" |
https://ror.org/03h2bh287 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The findings of this research study will be published in research journals, presented at national and international conferences. Locally the findings will be presented to patients, staff and researchers. Planned publication in a peer-reviewed journal in July 2024. A full study protocol will be published and a link will be made available. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 4 | 04/12/2022 | 12/12/2022 | No | No |
| Protocol article | 02/02/2023 | 03/02/2023 | Yes | No | |
| Statistical Analysis Plan | version 1.0 | 07/06/2023 | 09/06/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 27/03/2024 | 25/07/2024 | Yes | No |
Additional files
Editorial Notes
25/07/2024: Publication reference added.
21/07/2023: The overall study end date has been changed from 31/07/2023 to 26/06/2023 and the plain English summary updated accordingly.
09/06/2023: Statistical analysis plan uploaded.
03/02/2023: Publication reference added.
06/01/2023: The recruitment end date was changed from 31/01/2023 to 02/01/2023. Total final enrolment added.
12/12/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/02/2022 to 23/02/2022.
2. The target number of participants was changed from 322 to 332.
3. Great Western Hospitals NHS Foundation Trust was added to the trial participating centres.
4. Protocol uploaded (not peer reviewed).
31/12/2021: Trial's existence confirmed by the NIHR.
