Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05752331 |
Other study ID # |
LCACORN |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2022 |
Est. completion date |
June 15, 2023 |
Study information
Verified date |
August 2023 |
Source |
Bournemouth University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This pilot RCT aims to assess whether a simple PA behavioural modification intervention can
be delivered safely and feasibly to individuals with Long COVID suffering long standing
symptoms with concerns regarding their ability to perform activities of daily living.
Participants will be randomised to receive an 8-week physical activity behavioural
modification intervention alongside usual care or usual care alone. The primary outcome for
this study is to assess the safety and feasibility of the intervention, including recruitment
targets, randomisation, completion rates and acceptability to the study.
Description:
Coronavirus (COVID-19) is an infectious disease caused by the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), infecting over 254 million people worldwide to date.
While the majority of positive cases have uncomplicated recoveries, some have prolonged
periods of persistent symptoms, referred to as Long Covid (symptoms ≥12 weeks). Many of the
typical symptoms observed in those with Long Covid (fatigue, shortness of breath & cognitive
dysfunction) are compounded by deconditioning associated with a sedentary lifestyle. This has
become a major concern due to enforced lockdowns impacting individuals' abilities to conduct
activities of daily living (ADL), causing many to resort to sedentary lifestyles. Worryingly,
a significant association between sedentary behaviour and mental wellbeing has been
highlighted in those with Long Covid, negatively impacting both physical and psychological
symptoms.
Current research has focused on the lived experiences of people with Long Covid and how they
undertake ADL. Key barriers to ADL included an ever-increasing depletion of energy reserves
during low intensity physical activity (PA), an inability to manage symptoms of fatigue and
breathlessness, and high levels of anxiety associated with safely pursing the potential
benefits of PA. What's promising is that after expressing these barriers many individuals
wished to prioritise recovery and return to a greater level of ADL as it provided a sense of
normalisation and boosted overall mood. Subsequently, future research needs to investigate
potential interventions which positively impact upon the sedentary behaviour of those with
Long Covid and increase their ability to conduct ADL. Importantly, interventions of this
nature must focus on reducing the symptoms of Long Covid during PA in order to promote a
sense of safety while individuals purse the benefits of PA.
Therefore, this pilot randomised control trial (RCT) aims to assess whether a simple PA
behavioural modification intervention can be delivered safely and feasibly to individuals
with Long Covid who haven't been hospitalised due to Covid-19.
This pilot RCT will constitute a two parallel group study, with individuals randomised 1:1 to
either an 8-week PA behavioural modification intervention alongside usual care (intervention
group) or usual care alone (control group). Individuals with long standing symptoms (≥12
weeks) of COVID-19 who haven't previously been hospitalised will be recruited through
university (staff & students) and community based non-NHS groups in order to avoid lengthy
NHS ethical approval during feasibility. Eligible participants will attend 2 visits to a BU
laboratory at baseline (week 0) and study completion (week 9) to complete all physiological
and psychological measures (detailed below).
The 8-week PA behavioural modification intervention will focus on engaging participants in
ADL and lowering sedentary time. Each participant will receive one semi-structured
motivational interview at baseline to discuss favourite activities and barriers and
facilitators to PA. Participants will produce an individualised action plan following the
interview that will be followed throughout the intervention to allow an individualised
approach to take place. Participants will then be provided with a low-cost pedometer and PA
diary to self-monitor and record daily PA. The PA diary will provide examples of various
activities that can be done in and around the house, with an emphasis placed on simple,
effective movements to reduce sedentary time. Following this, a researcher will conduct
weekly virtual meetings with the participant to discuss the past weeks PA levels and provide
future individualised goals to promote ADL. All participants will be notified of the
government 'your Covid recovery' programme (usual care) which provides details and support on
managing long term symptoms of Covid-19.