Feasibility of Personalised Health Behaviour Coaching to Support Symptoms and Activities of Daily Living in Those With Long COVID-19.

NCT ID: NCT05752331

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-06-15

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.

Conditions

Long COVID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Physical activity behavioural modification

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.

Group Type: EXPERIMENTAL

Physical activity behavioural modification

Intervention Type: BEHAVIORAL

8-week intervention consisting motivational interview, individualised action plan and weekly consultations regarding activities of daily living and symptom management.

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity behavioural modification

8-week intervention consisting motivational interview, individualised action plan and weekly consultations regarding activities of daily living and symptom management.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bournemouth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Armstrong

Role: PRINCIPAL_INVESTIGATOR

Bournemouth University

Locations

Bournemouth University

Bournemouth, Dorset, United Kingdom

Countries

United Kingdom

Other Identifiers

LCACORN

Identifier Type: -

Identifier Source: org_study_id