Clinical trial NCT05752331: Feasibility of Personalised Health Behaviour Coaching to Support Symptoms and Activities of Daily Living in Those With Long COVID-19.
Official title: Feasibility of Personalised Health Behaviour Coaching to Support Symptoms and Activities of Daily Living in Those With Long COVID-19.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Keywords: Physical activity
Fatigue
Breathlessness
Lead sponsor: Bournemouth University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* People who are aged 18 years or older
* Have experienced at least one long COVID symptom for 12 weeks or longer
* Additionally meet at least one of the following criteria: 1) positive SARS-CoV-2 PCR or antigen test (positive COVID-19 test) during the acute phase of illness; 2) positive SARS-CoV-2 antibody test at any time point; 3) symptoms consistent with SARS-CoV-2 (COVID-19) infection during the acute phase.

Exclusion Criteria:

* Individuals who have previously been admitted to an intensive care unit (ICU) due to SARS-CoV-2
* Receiving palliative or end-of-life care
* Are actively participating in another research trial focused on long COVID

Primary outcomes:
measure: Participant recruitment
timeFrame: 8 weeks
measure: Participant randomisation
timeFrame: 8 weeks
measure: Participant completion
timeFrame: 8 weeks
measure: Participant acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: Objective physical activity
timeFrame: 8-weeks
measure: Exercise capacity
timeFrame: 8-weeks
measure: Muscular strength and endurance
timeFrame: 8-weeks
measure: Lung Function
timeFrame: 8-weeks
measure: Health related quality of life
timeFrame: 8-weeks
measure: Breathlessness
timeFrame: 8-weeks
measure: Fatigue
timeFrame: 8 weeks
measure: Anxiety and Depression
timeFrame: 8-weeks
measure: Cognitive impairment
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Bournemouth University
state: Dorset
Study officials:
affiliation: Bournemouth University
name: Matthew Armstrong
role: PRINCIPAL_INVESTIGATOR
References: