Administrative information
Title | The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): Protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium |
Trial Registration | ISRCTN trial registry ISRCTN13293865 & ISRCTN10980107 |
Protocol version | 1.1, 23 September 2021 |
Funding | Funding Jointly funded by UK Research and Innovation and National Institute of Health Research (grant references: MR/V027859/1 and COV0319) and by core funding provided by NIHR Leicester Biomedical Research Centre - a partnership between the University Hospitals of Leicester NHS Trust, the University of Leicester and Loughborough University and by pump priming funding provided by Northumbria University Newcastle (MDRT IHSC and HLS Faculty). Professor Singh is a National Institute for Health Research (NIHR) Senior Investigator. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, or the Department of Health and Social Care. |
Author details | As listed on page 1-2 |
Name and contact for the trial sponsor | University of Leicester rgosponsor@leicester.ac.uk |
Role of sponsor | Legal responsibility and governance of the PHOSP-COVID trial |
Introduction
Background and rationale
Objectives
Primary objective
Secondary objectives
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To compare the efficacy of face-to-face and/or digital COVID-19 rehabilitation strategies to a usual care in improving exercise capacity and symptoms in individuals following a COVID-19 hospitalisation
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Investigate the effect of face-to-face rehabilitation vs. usual care on immune cell counts, inflammatory cell phenotypes and stimulated-immune cell inflammatory cytokine release in blood biomarkers
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To understand the skeletal muscle response to rehabilitation in patients with ongoing post-COVID symptoms, including metabolic, gene/protein expression, and inflammatory changes
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To understand barriers and facilitators to the delivery and implementation of COVID rehabilitation (digital and face-to-face) in people with ongoing post-COVID symptoms, and staff delivering the service
Methods
Trial design and setting
Participants—eligibility criteria
Who will take informed consent
Additional consent provisions for collection and use of participant data and biological specimens
Interventions
Face-to-face rehabilitation
Digital rehabilitation
Usual care (control)
Criteria for discontinuing/modifying interventions
Provisions for post-trial care
Outcomes
Primary outcome measure
Secondary outcome measures
Outcome | Timepoint |
---|---|
Incremental Shuttle Walking Test (ISWT) | Primary |
Short Physical Performance Battery (SPPB) | Secondary |
Quadriceps Maximal Voluntary Contraction (QMVC) | Secondary |
Handgrip strength | Secondary |
Physical activity | Secondary |
EuroQol 5 domain 5 level (EQ5D-5L) | Secondary |
Patient Health Questionnaire (PHQ-9) | Secondary |
Generalised Anxiety Disorder (GAD-7) | Secondary |
Dyspnoea 12 (D12) | Secondary |
SARC-F | Secondary |
Modified Medical Research Council (MRC) dyspnoea scale | Secondary |
Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-FS) | Secondary |
General Practice Physical Activity Questionnaire (GPPAQ) | Secondary |
Nottingham Extended Activities of Daily Living (NEADL) | Secondary |
Depauls Symptom Questionnaire (DSQ) | Secondary |
Montreal Cognitive Assessment (MoCA) | Secondary |
Nijmegen questionnaire | Secondary |
Blood markers | Exploratory—optional |
Muscle biopsies | Exploratory—optional |