Rehabilitation for those with lasting symptoms of COVID-19 post hospitalisation

ISRCTN	ISRCTN13293865
DOI	https://doi.org/10.1186/ISRCTN13293865
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	285439
Protocol serial number	IRAS 285439
Sponsor	University of Leicester
Funders	UK Research and Innovation, National Institute for Health Research

Submission date: 12/04/2022
Registration date: 06/07/2022
Last edited: 01/08/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This is a sub-study of the PHOSP-COVID study to explore COVID rehabilitation for people who have lasting symptoms. As COVID-19 is a new disease and some people have remaining symptoms, researchers want to understand if a rehabilitation programme can improve symptoms. They want to understand:
1. If an exercise and education programme can help improve symptoms following a COVID-19 admission compared to no programme
2. If a face-to-face programme or web-based programme can improve symptoms following COVID-19
3. The impact these programmes have on the immune system (measured by blood tests) and muscle function (measured by optional biopsies)

Who can participate?
Individuals with ongoing symptoms following hospitalisation with COVID-19

What does the study involve?
Participants will be randomly allocated to receive either a web-based programme, a face-to-face programme or no programme for 8 weeks. Participants who receive no programme will be offered one of the other programmes after the study. Before and after the intervention, participants complete questionnaires, walking tests, blood tests and strength tests. There is an optional muscle biopsy study which would require a small sample to be taken from the thigh, and an optional exercise test with a wearable vest to assess breathing.

What are the possible benefits and risks of participating?
The intervention is aimed to help people manage their lasting symptoms of COVID and participants may experience some benefit in taking part, but this intervention is being tested and therefore benefits are not guaranteed. The results may help in caring for other patients in the future. There is minimum risk and all information will be used anonymously. Whenever possible the additional samples will be taken at the same time as regular samples to reduce the extra procedures. There is a risk of pain or discomfort when samples are taken.

Where is the study run from?
NIHR Leicester Biomedical Research Centre (UK)

When is the study starting and how long is it expected to run for?
July 2020 to July 2023

Who is funding the study?
1. UK Research and Innovation (UK)
2. National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Dr Enya Daynes
enya.daynes@uhl-tr.nhs.uk

Contact information

Dr Enya Daynes
Principal investigator

NIHR Leicester Biomedical Research Centre (Respiratory)
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

ORCID ID	0000-0003-0127-1649
Phone	+44 (0)116 2583370
Email	enya.daynes@uhl-tr.nhs.uk

Mr George Mills
Public

NIHR Leicester Biomedical Research Centre (Respiratory)
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

ORCID ID	0000-0002-3907-6753
Phone	+44 (0)116 2583652
Email	george.mills@uhl-tr.nhs.uk

Dr Molly Baldwin
Scientific

NIHR Leicester Biomedical Research Centre (Respiratory)
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

ORCID ID	0000-0002-6269-7961
Phone	+44 (0)116 2583652
Email	molly.baldwin@uhl-tr.nhs.uk

Study information

Primary study design	Interventional
Study design	Multicentre parallel randomized controlled trial
Secondary study design	Randomised parallel trial
Participant information sheet	41556_PIS_V1.1_23Sep21.pdf
Scientific title	PHOSP-COVID - Rehabilitation for lasting symptoms of COVID-19
Study acronym	PHOSP Rehab
Study objectives	To understand the clinical effectiveness of the candidate recovery interventions in the post-hospitalised PHOSP-COVID population in those with ongoing symptoms compared to ‘usual care’.
Ethics approval(s)	Approved 06/10/2021, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8134; leedswest.rec@hra.nhs.uk), ref: 20/YH/0225
Health condition(s) or problem(s) studied	Ongoing symptoms following COVID infection and hospitalisation
Intervention	Patients will be randomised on a 1:1:1 ratio. Those that are able to access only one of the two interventions (face to face or digital) will be randomised on a 2:1 ratio to the accessible intervention or usual care (for example if not digitally literate they will be randomised to either f2f or usual care). 1. Web-based rehabilitation programme (Your COVID Recovery® Programme): this intervention is 8 weeks in duration and allows participants to work through four phases, 2 weeks per phase. This is a semi-supported exercise and education programme delivered via a web platform. Participants are contacted every 2 weeks to support progression to next phase. 2. Face-to-face rehabilitation programme: this is an 8-week programme, supervised sessions twice per week. The sessions last 90-120 minutes and cover aerobic and strength training and education sessions. 3. Control (usual clinical care): usual care currently does not include the provision of rehabilitation. Any other routine appointments and treatment plans will continue throughout this intervention.
Intervention type	Behavioural
Primary outcome measure(s)	Performance is measured using the Incremental Shuttle Walking Test at baseline and 8-week follow up
Key secondary outcome measure(s)	1. HRQOL is measured using the Functional Assessment of Chronic Illness Test- Fatigue total score at baseline and 8-week follow up 2. HRQOL is measured using the Nottingham extended Activities of Daily Living questionnaire at baseline and 8-week follow up 3. HRQOL is measured using the EuroQuol 5 domain at baseline and 8-week follow up 4. Breathlessness is measured using the Dyspnoea-12 at baseline and 8-week follow up 5. Cognitive impairment is measured using the Montreal Cognitive Assessment at baseline and 8-week follow up 6. Pain is measured using the Brief Pain Inventory at baseline and 8-week follow up 7. Symptoms of depression are measured using the Patient Health Questionnaire-9 at baseline and 8-week follow up 8. Symptoms of anxiety are measured using the General Anxiety Disorder 7 Questionnaire at baseline and 8-week follow up 9. Presence of sarcopenia is measured using the SARC-F at baseline and 8-week follow up 10. Quadriceps strength is measured using the Quadriceps Maximal Voluntary Contraction at baseline and 8-week follow up 11. Handgrip strength is measured using a grip strength dynamometer at baseline and 8-week follow up 12. Physical activity is monitored using the GENEActiv wrist-worn actigraphy device for 1 week following the initial study visit and between weeks 7-8 13. Breathing dysfunction is measured using the Nijmegan questionnaire at baseline and 8-week follow up 14. Functional capacity is measured using the Short Physical Performance Battery at baseline and 8-week follow up
Completion date	10/07/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	159
Total final enrolment	186
Key inclusion criteria	1. Ongoing symptoms following COVID-19 infection that are deemed modifiable by a rehabilitation programme 2. Hospitalisation during an acute infection of COVID-19
Key exclusion criteria	1. Unwilling to consent for the trial 2. Full recovery of symptoms reported by the patient (physical and psychological) 3. Persistent symptoms indicative of other significant medical conditions that require further investigation/management 4. Currently on or recently completed a course of COVID rehabilitation (previous 6 months) 5. Contraindications for exercise (American College of Sports Medicine)
Date of first enrolment	07/12/2021
Date of final enrolment	15/05/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

NIHR Leicester Biomedical Research Centre

Gwendolen Rd
Leicester
LE5 4QF
United Kingdom

NIHR Newcastle Biomedical Research Centre

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	Participants have not consented to share individual data and therefore will not be shared. However, group data can be shared upon reasonable request to Dr Enya Daynes (enya.daynes@uhl-tr.nhs.uk). Data handling and record-keeping will be in accordance with the PHOSP-COVID study procedures. Clinical paperwork arising from the intervention will be inputted onto paper and/or electronic CRFs and stored electronically onto RedCAP alongside the PHOSP-COVID study data. Clinical paperwork will be filled in the medical notes as is standard practice. The sub-study data will be stored on the PHOSP Redcap and eCRF alongside the main PHOSP data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		22/05/2025	01/08/2025	Yes	No
Protocol article		26/01/2023	27/01/2023	Yes	No
HRA research summary			26/07/2023	No	No
Participant information sheet	version 1.1	23/09/2021	13/04/2022	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

41556_PIS_V1.1_23Sep21.pdf: Participant information sheet

Editorial Notes

01/08/2025: Publication reference added.
07/08/2024: Total final enrolment added.
06/08/2024: The intention to publish date was changed from 10/10/2023 to 10/10/2024.
03/05/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2022 to 15/05/2023.
2. The overall end date was changed from 30/04/2022 to 10/07/2023.
3. The intention to publish date was changed from 01/07/2023 to 10/10/2023.
4. The plain English summary was updated to reflect these changes.
27/01/2023: Publication reference added.
08/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2022 to 28/02/2022.
2. The overall trial start date has been changed from 16/07/2020 to 30/04/2022.
3. The intention to publish date was changed from 01/05/2023 to 01/07/2023.
02/09/2022: The recruitment end date was changed from 30/09/2022 to 30/11/2022.
11/08/2022: The overall trial start date has been changed from 04/10/2021 to 16/07/2020 and the plain English summary updated accordingly.
13/04/2022: Trial's existence confirmed by the Yorkshire & The Humber - Leeds West Research Ethics Committee.