The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol... 2023 Daynes et al

Full 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

Abstract

Introduction
Many adults hospitalised with COVID-19 have persistent symptoms such as fatigue, breathlessness and brain fog that limit day-to-day activities. These symptoms can last over 2 years. Whilst there is limited controlled studies on interventions that can support those with ongoing symptoms, there has been some promise in rehabilitation interventions in improving function and symptoms either using face-to-face or digital methods, but evidence remains limited and these studies often lack a control group.

Methods and analysis
This is a nested single-blind, parallel group, randomised control trial with embedded qualitative evaluation comparing rehabilitation (face-to-face or digital) to usual care and conducted within the PHOSP-COVID study. The aim of this study is to determine the effectiveness of rehabilitation interventions on exercise capacity, quality of life and symptoms such as breathlessness and fatigue. The primary outcome is the Incremental Shuttle Walking Test following the eight week intervention phase. Secondary outcomes include measures of function, strength and subjective assessment of symptoms. Blood inflammatory markers and muscle biopsies are an exploratory outcome. The interventions last eight weeks and combine symptom-titrated exercise therapy, symptom management and education delivered either in a face-to-face setting or through a digital platform (www.yourcovidrecovery.nhs.uk). The proposed sample size is 159 participants, and data will be intention-to-treat analyses comparing rehabilitation (face-to-face or digital) to usual care.

Ethics and dissemination
Ethical approval was gained as part of the PHOSP-COVID study by Yorkshire and the Humber Leeds West Research NHS Ethics Committee, and the study was prospectively registered on the ISRCTN trial registry (ISRCTN13293865). Results will be disseminated to stakeholders, including patients and members of the public, and published in appropriate journals.

Article summary
Strengths and limitations of this study

• This protocol utilises two interventions to support those with ongoing symptoms of COVID-19

• This is a two-centre parallel-group randomised controlled trial

• The protocol has been supported by patient and public involvement groups who identified treatments of symptoms and activity limitation as a top priority

Open access, https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07093-7

 

"Participants—eligibility criteria

Participants are eligible if they were admitted to hospital during the acute phase of their COVID-19 confirmed (by PCR) or clinician diagnosed COVID-19 and have ongoing symptoms lasting more than 12 weeks, with no upper limit, that may be modifiable by a rehabilitation programme. These symptoms include reduced activity/exercise tolerance, fatigue, dyspnoea, musculoskeletal pain, short-term memory loss and a slowing down in thinking [14].

Individuals with a contraindication for exercise, as documented in the American College of Sports Medicine guidance, symptoms indicative of another medical condition that require further investigation/management or unstable comorbidities that require follow-up (i.e. palpitations), or who have completed COVID-19/exercise rehabilitation in the preceding 6 months will be excluded from the study. Those who were not admitted to hospital during their SARS-Cov-2 infection will be excluded [22]. Individuals must be willing to attend the face-to-face rehabilitation programme and/or access the digital rehabilitation programme to participate in this study. Those with a diagnosis of post exertional malaise or in the absence of a diagnosis but experiences severe debilitating fatigue (home or bed bound) that worsens with activity will not be recruited to this study."

 

Is one interpretation, I personally was glad to see this exclusion so that people with PEM aren't harmed.

 

Wow, it's clear that knowledge of PEM and that exercise isn't safe is spreading throughout medicine based on this.