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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

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

Conditions
-----------------
COVID-19, Respiratory Disease

Intervention / Treatment
-----------------
* Other: Breathing techniques over 12 sessions / 6 weeks inc yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single site, pilot RCT of intervention compared to usual care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Breathing Techniques Intervention<br>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. | Other: Breathing techniques over 12 sessions / 6 weeks inc yoga<br>* as above<br>|
| No Intervention: Usual Care<br>A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathlessness. | Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse | 7 weeks | 
| Function | 5 repetition chair to stand. Range 0-120 seconds with longer worse | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnoea-12 Questionnaire | SOB questionnaire. Range 0-36, Greater, worse | 7 weeks | 
| Nijmegen Questionnaire | Measure of dysregulated breathing. 0-64. Greater worse | 7 weeks | 
| Borg Scale of Breathlessness | Measure of breathlessness. Range 0-10. Greater worse | 7 weeks | 
| Four metre Gait speed | field test of physical performance. Range 0-60seconds. Greater worse | 7 weeks | 
| Modified Minnesota Physical Activity | Questionnaire. Range 0-100. Greater better. | 7 weeks | 
| Capnography - in some volunteers | End tidal CO2 measure in breath - at rest. Range N/A | 7 weeks | 
| Chalder Fatigue Score | Questionnaire. Range 0-33. Greater worse | 7 weeks | 
| EQ5D Quality of Life score | Questionnaire. VAS 0-100. Greater is better. | 7 weeks | 
| Adherence | Recorded from number of potential sessions. Range 0-12. Greater better. | 7 weeks | 
| Breath hold, Respiratory rate | Observational measures at rest. Breath hold - 0-45. Greater better. RR. Range 0-30. Greater worse | 7 weeks |