Post COVID REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing (REMEDY): COVID-19
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- University of Nottingham
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Breathlessness.
- Status
- Active, not recruiting
- Last Updated
- last year
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).
Investigators
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
Outcomes
Primary Outcomes
Breathlessness.
Time Frame: 7 weeks
Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse
Function
Time Frame: 7 weeks
5 repetition chair to stand. Range 0-120 seconds with longer worse
Secondary Outcomes
- Nijmegen Questionnaire(7 weeks)
- Chalder Fatigue Score(7 weeks)
- Borg Scale of Breathlessness(7 weeks)
- Capnography - in some volunteers(7 weeks)
- Dyspnoea-12 Questionnaire(7 weeks)
- Modified Minnesota Physical Activity(7 weeks)
- Four metre Gait speed(7 weeks)
- EQ5D Quality of Life score(7 weeks)
- Adherence(7 weeks)
- Breath hold, Respiratory rate(7 weeks)