COVID-19, Respiratory Disease
Conditions
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).
Interventions
OTHERBreathing techniques over 12 sessions / 6 weeks inc yoga
as above
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
A single site, pilot RCT of intervention compared to usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathlessness. | 7 weeks | Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse |
| Function | 7 weeks | 5 repetition chair to stand. Range 0-120 seconds with longer worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnoea-12 Questionnaire | 7 weeks | SOB questionnaire. Range 0-36, Greater, worse |
| Nijmegen Questionnaire | 7 weeks | Measure of dysregulated breathing. 0-64. Greater worse |
| Borg Scale of Breathlessness | 7 weeks | Measure of breathlessness. Range 0-10. Greater worse |
| Four metre Gait speed | 7 weeks | field test of physical performance. Range 0-60seconds. Greater worse |
| Modified Minnesota Physical Activity | 7 weeks | Questionnaire. Range 0-100. Greater better. |
| Capnography - in some volunteers | 7 weeks | End tidal CO2 measure in breath - at rest. Range N/A |
| Chalder Fatigue Score | 7 weeks | Questionnaire. Range 0-33. Greater worse |
| EQ5D Quality of Life score | 7 weeks | Questionnaire. VAS 0-100. Greater is better. |
| Adherence | 7 weeks | Recorded from number of potential sessions. Range 0-12. Greater better. |
| Breath hold, Respiratory rate | 7 weeks | Observational measures at rest. Breath hold - 0-45. Greater better. RR. Range 0-30. Greater worse |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORCharlotte Bolton
University of Nottingham
Outcome results
None listed