Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing (REMEDY)

Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing

Post COVID REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing (REMEDY): COVID-19

A pilot Study To investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following COVID-19 when compared to usual care.

Pilot RCT for upto 60 subjects across 2 arms Intervention A 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. Each group will aim for between 3- 6 participants. Each online session will be circa 40-50 minutes in length. This will include an Introduction and warm up; Breathing practice including yogic breathing and a final cool down and relaxation. Sessions will run at set times to ensure efficient use of resources but will try to accommodate different time points periods of the day when patients might be functioning best. Comparator A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention. Primary co-outcomes Change in Breathlessness: Chronic Respiratory Disease Questionnaire-Dyspnoea domain (CRQ-D) Functional measure: 5 repetition chair to stand (5RCTS) Secondary measures include other measures of breathlessness, function, adherence and completion (see full text for detail).

Randomisation will be completed in a 1:1 ratio (Intervention: Usual Care) using a sealed envelope block randomisation process. The study will be single blinded and controlled through the use of a distinct intervention team and an outcomes team. The intervention team will manage the randomisation and intervention session and planning. The outcomes team will be blinded to the intervention or usual care.

A 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. Each group will aim for between 3- 6 participants.

A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.

Inclusion Criteria: Either hospitalised or non-hospitalised with confirmed COVID-19 acute infection. Received a comprehensive clinical respiratory assessment Persisting (>12 weeks) self-reported breathlessness (on CRQ-D) following COVID-19 and confirmed dysregulated breathing (Nijmegen Questionnaire score NQ >23) Age 18 - 80 years of age Ability to give informed consent Able to understand and speak English language Exclusion Criteria: Severe mood disturbance that limits engagement with the intervention and study outcomes No access to online delivery and/or IT illiterate Significant diagnosed Myalgic Encephalitis/Fibromyalgia/Chronic Fatigue Syndrome prior to developing COVID-19 Severe asthma or other chronic lung disease prior to COVID-19