Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial

Ethical approval

Ethical approval was received from the East of England-Cambridge South Research Ethics Committee (REC: 20/EE/0235).

Written informed consent for publication of the participants details and/or their images was obtained from the participants.

Overview of the development process

We followed the Medical Research Council framework¹³ for design of complex interventions (Figure 1). Our manuscript adheres to the recent Template for Intervention Development and Replication (TIDieR) for ‘telehealth’ complex interventions¹⁴. Work was conducted between August 2020 and January 2021.

Figure 1. Intervention development process.

Stage 1: Exploratory, background research (patient experience, evidence base, expert opinion, current practice)

A search of bibliographic databases (MEDLINE, PsycInfo and CINAHL) identified literature relating to behavioural or self-management needs for people living with long-COVID. Due to the relative paucity of long-COVID research, we also searched for literature on chronic fatigue syndrome (CFS), chronic obstructive pulmonary disease (COPD), and the 2002–2004 SARS epidemic. Collectively these conditions exhibit several of the most common and debilitating symptoms of long-COVID (e.g. fatigue, lethargy, breathlessness, muscle weakness, brain fog).

Titles and abstracts of papers were assessed for relevance, prioritising recent systematic reviews of needs and interventions in long-COVID, CFS, COPD and SARS. Articles were examined to ensure that the needs identified by our stakeholder groups were addressed by research evidence where possible. Reports of interventions for conditions with similar symptoms helped to identify core components that may be effective for people living with long-COVID.

The literature review revealed limited evidence regarding the efficacy of rehabilitation interventions for COVID-19 survivors⁹. One RCT (n=72) of respiratory rehabilitation reported improved respiratory function, quality of life (QoL) and anxiety in elderly people with COVID-19¹⁵, but there was little other data available. In other similar conditions, a meta-analysis of 65 RCTs involving 3822 participants reported that pulmonary rehabilitation programmes, combining exercise with various psychological support and education components, were beneficial in improving health-related quality of life (HR-QoL) and exercise capacity in people with COPD¹⁰. Similarly, a meta-analysis of eight RCTs (n=1518) concluded that people with CFS may generally benefit and feel less fatigued following exercise therapy, comparable to the effectiveness of cognitive behavioural therapy (CBT), with no evidence to suggest that exercise therapy may worsen outcomes¹⁶. Exercise training was also reported to be effective in improving cardiorespiratory and musculoskeletal fitness in people recovering from SARS, although there was no reported effect on HR-QoL¹¹. Other studies highlighted the persistent mental and physical abnormalities in SARS survivors up to two years post-infection¹⁷. Exercise therapy alone, therefore, is likely insufficient to optimise recovery for people with long-COVID.

We concluded that to combat the multiple long-term physical and mental health consequences of COVID-19, a combined physical and psychological rehabilitation intervention was required. In order to make the programme as widely accessible as possible during COVID-19 ‘lock-downs’ and reduced access to healthcare, the intervention was developed to be deliverable online.

Stage 2: Production of draft REGAIN intervention

To holistically appraise the needs of people with long-term COVID-19 symptoms following hospitalisation, a core intervention development team was formed. The team (n=22) had specialism and extensive experience in clinical academia, physiotherapy, psychiatry, health psychology, clinical exercise physiology, critical care medicine, complex intervention development and implementation, and online rehabilitation and behavioural support. Six people (male n=3, female n=3; age 33–62 years) with symptoms of long-COVID (3–9 months duration) were also involved throughout every stage of the development of the REGAIN intervention (patient and public involvement (PPI) group). Online meetings facilitated discussions informed by evidence from Stage 1 development. The team met frequently with the objective of identifying and formulating the key components of a complex intervention.

The research team identified key themes and priorities from the literature to form the outline for a series of online discussions held between August and October 2020 (Table 1). Consensus responses relating to core components for inclusion in the exercise and behavioural support intervention were collated into the following categories: online group exercise classes (frequency, intensity, time and type principles), concerns about post exertional malaise/chronic fatigue, exercise programme progression, behavioural support materials, and the feasibility of delivering the intervention online in a NHS setting to participants with diverse symptomology and varying degrees of information technology (IT) literacy. Findings from the stakeholder meetings are summarised in Table 1. A framework of a draft intervention was finalised for pre-pilot testing.

Post exertional malaise

During the development phase, the trial team were contacted by several organisations representing the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) community with concerns relating to the potential harms of unsupervised vigorous exercise for people with long-COVID, in particular the risk of post-exertional malaise¹⁸. We recognised the lived experience and expertise within these groups and sought to ensure that REGAIN practitioners were appropriately trained in risks relating to post-exertional malaise. Furthermore, early identification screening measures for post-exertional malaise were incorporated into the intervention protocols, particularly during the initial one-to-one consultation and every subsequent exercise session. Practitioners were encouraged to monitor the progress of participants during and after exercise sessions in order to ensure that exercise intensity and volume were within individuals’ capabilities and did not cause undue persistent fatigue or other problems.

Stage 3: Pre-pilot testing of the REGAIN intervention

To test acceptability and deliverability, the draft REGAIN intervention was feasibility tested in a pre-pilot study with eight people living with long-COVID. The online exercise and behavioural support sessions were delivered from a community NHS exercise rehabilitation facility (Atrium Health, Centre for Exercise and Health, Coventry). Feedback was gathered on the acceptability and practicality of the intervention from eight participants as well as the healthcare practitioners delivering the intervention. This included comments on the written and online trial materials (e.g. practitioner/participant manuals) and the online platforms used to deliver the intervention. This helped the trial team further refine and develop the intervention before proceeding to the main trial. The key findings from the pre-pilot stage are described in Table 2.

Stage 4: Refinement of the REGAIN intervention

On-demand exercise and educational videos. The intervention team, with the support of our patient partners, developed 14 ‘on-demand’ exercise videos which used a similar format to the live online exercise sessions and were designed to account for all abilities. Lower intensity videos with postural stability and balance exercises were included for people with more pronounced levels of fatigue or disability. Some videos were themed (e.g., shopping, housework) to reintroduce activities of daily living and to add some additional context for those unaccustomed to exercise videos. We also included videos of other exercise modalities (e.g., Yoga, Pilates, and high intensity interval training (HIIT)), which had already been produced by the online physical activity provider (BeamFeelGood) used to deliver the intervention. Finally, five videos providing advice and education on lung function and care, including breathing techniques/exercises (Fit for Surgery team, University Hospital Birmingham) and six ‘mindfulness’ videos (Dr Gail Davies) were produced to give participants additional online resources. All videos were hosted on the online platform via a trial-specific protected user area. Participants were encouraged to access these exercise videos, unsupervised, between weekly group sessions and to progress to performing up to two additional exercise sessions per week as tolerated.

Practitioner-led online group exercise sessions

A series of 12 templates were designed for the online group exercise sessions. They ranged in modality from low intensity chair-based activity to higher intensity whole body exercise. These formed the basis of all online group exercise sessions and ensured a level of exercise programme standardisation throughout the trial. All the exercises within each template required little or no equipment and were easily modifiable to account for different ability levels within the group. Depending on the group, different exercises were swapped in or out of the session template to cater for the specific needs. Generally, the templates included 7–8 exercises to be completed 2–3 times (i.e., 2-3 circuits). The warm-up and cool down lasted 5–10 minutes each.

Overview of REGAIN intervention

The final REGAIN exercise and behavioural support intervention consisted of four main components delivered by clinical exercise physiologists or physiotherapists (REGAIN practitioners). The final intervention structure and accompanying logic model are presented in Figure 2) and Figure 3 respectively.

Figure 2. Final format and components of the ‘Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN) intervention.

Figure 3. Logic model for the REGAIN intervention.

Online one-to-one consultation

The one-to one consultation with a REGAIN practitioner included several components and was designed to triage the participant for safe exercise, and familiarise them with the IT requirements:

Eight-week exercise programme

The online exercise rehabilitation programme delivered by REGAIN practitioners consisted of up to 30 minutes of light to moderate intensity exercise two to three times per week for eight weeks. Practitioners individualised group sessions to accommodate varying abilities, with progressive multi-modality exercise at a manageable intensity, monitored with breathlessness and perceived exertion scales. Participants were encouraged to attend one live online group exercise session each week, and additionally access the online, pre-recorded exercise videos once or twice each week. This equipment-free exercise programme aimed to improve cardiovascular fitness, strength, balance, co-ordination, and confidence. Sessions were undertaken in discrete groups where participants remained in the same group over the eight-week programme. An example of an intermediate level exercise session is presented in Table 3.

Online group support sessions

Emerging evidence highlighted the importance of the biopsychosocial model^19,20 in understanding the interrelationships among risk factors and multidimensional clinical and psychosocial COVID-19 outcomes. The support sessions were based on behaviour change theory (Michie’s COM-B model: mapping key processes and functions to enhance Capability, Opportunity, and Motivation)²¹, self-efficacy²², motivational interviewing²³, and group-based learning²⁴. These theoretical principles were used to inform the psychosocial content, structure and delivery of the sessions in combination with the British Psychological Guidance for management of long-COVID which was available at the time²⁵.

To enhance the psychological capability of participants (as per the COM-B model), support sessions, delivered by REGAIN practitioners, were designed to increase knowledge and understanding about COVID-19 and its impact on daily living. Feedback from patient partners highlighted the need for practitioners to address misinformation from various sources (e.g., friends/relatives, news, social media etc.) which often caused more anxiety and distress. Reduced processing and retention of information due to brain fog and poor concentration also informed the design and content of the support sessions. Resources and activities could be paused at any time and revisited by participants via the provided study materials (PowerPoint presentations, written summaries of key topics, video clips and further reading). Motivation was incorporated into support sessions through exploration of self-identity and the meaning of COVID-19 to the participants and those around them (e.g., family). By discussing COVID-19 experiences in a group setting, participants could see that others were having the same issues and could share experiences and coping strategies. The aim was for participants to feel validated that their symptoms were not only real, but that they were not alone in experiencing them.

Opportunity was the third core principle incorporated into the support sessions: participants were permitted time to engage in sessions in a supportive environment. Group based support sessions were chosen because they can promote behaviour change through shared values and norms, influencing beliefs, and encouraging common motivations and behavioural patterning. We stressed the importance of engaging with all elements of the intervention. To help attenuate fatigue, group support sessions were no longer than 60 minutes. The six group support sessions below are further summarised in Table 4:

Session 1: Introduction, expectations, motivation and goal setting

Session 2: Fear avoidance and pacing

Session 3: Recovery and sleep, sleep management strategies

Session 4: Management of emotions (perceived stigma, mood/unhelpful thoughts)

Session 5: Understanding stress and anxiety, and management strategies

Session 6: Managing setbacks and long-term behaviour change and future goals.

Behavioural support videos

Feedback from our patient partners and intervention practitioners suggested potential benefit of having a short video or conversation where topics could be explored and viewed during the group sessions. We developed short introductory videos for each of the six group support topics. The videos featured discussions between the trial health psychologist and patient partners, filmed and edited by a professional production company. Practitioners played the relevant video at the start of each group support session with the intention that participants may recognise patterns of behaviour in themselves, thus stimulating support group discussion.

Intervention fidelity: practitioner training and quality control

To ensure standardisation of intervention delivery, all REGAIN practitioners completed a full day of training. This included practical and theoretical components, delivered by a clinical exercise research fellow and health psychologist. Guidance was provided on delivery of behavioural education sessions, motivational interviewing techniques, and group facilitation skills. All practitioners completed an assessment after training, to gauge readiness to deliver the intervention and/or the need for further training or support. Practitioners were provided with comprehensive written instruction manuals, and met monthly with a senior health psychologist and other members of the intervention delivery team for ongoing support, advice and troubleshooting. All intervention components were within the scope of normal practice for the clinicians involved. The REGAIN intervention was designed for delivery by NHS clinical exercise physiologists or physiotherapists. All practitioners were subject to regular quality control reviews conducted by an independent health psychologist, clinical exercise physiologist, and qualitative researcher using pre-determined checklist criteria. This ensured that exercise and behavioural support sessions were delivered in a standardised manner. All online sessions were recorded for independent review as part of a separate process evaluation.

Safety

Supervised sessions were led by practitioners experienced in the assessment, prescription, and delivery of exercise for multi-morbid clinical populations. Pre-exercise session online poll questions were completed by participants to capture any adverse events experienced since the previous supervised session. Practitioners also ended each session by inquiring about any symptoms or adverse events the participants may have experienced. Participants with any issues were asked to remain online after the session or were contacted by telephone or email to explore further. If a participant failed to attend an intervention appointment, the practitioner attempted to contact them via telephone or email to ascertain their welfare.

Exercise carries a very small theoretical risk of complications. All participants were assessed during the one-to-one consultation for any underlying health conditions or severe complications related to COVID-19. Participants were excluded from the study at the eligibility stage where exercise was clearly contraindicated, as assessed by a clinical member of the research team. A further assessment was undertaken by the REGAIN practitioner, through discussion with the patient about their current health, at the time of the initial online intervention assessment. During all group online exercise and support sessions, a second practitioner (‘co-pilot’) was immediately available online to assist with any emergencies, or if a participant became unresponsive or left the session without prior notification.

Regulatory compliance

To ensure compliance with appropriate confidentiality and data protection regulation, the proposed online intervention delivery platform and associated data storage facilities were rigorously reviewed and approved by organisational Information Governance committees, further to submission of a comprehensive Data Protection Impact Assessment.