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

University of Nottingham40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

COVID-19 Respiratory Disease

Interventions

Breathing techniques over 12 sessions / 6 weeks inc yogaOTHER

as above

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Nottingham University Hospitals Trust

Nottingham, Notts, United Kingdom

Outcomes

Primary Outcomes

Breathlessness.

Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse

Time frame: 7 weeks

Function

5 repetition chair to stand. Range 0-120 seconds with longer worse

Time frame: 7 weeks

Secondary Outcomes

Dyspnoea-12 Questionnaire

SOB questionnaire. Range 0-36, Greater, worse

Time frame: 7 weeks

Nijmegen Questionnaire

Measure of dysregulated breathing. 0-64. Greater worse

Time frame: 7 weeks

Borg Scale of Breathlessness

Measure of breathlessness. Range 0-10. Greater worse

Time frame: 7 weeks

Four metre Gait speed

field test of physical performance. Range 0-60seconds. Greater worse

Time frame: 7 weeks

Modified Minnesota Physical Activity

Questionnaire. Range 0-100. Greater better.

Time frame: 7 weeks

Capnography - in some volunteers

End tidal CO2 measure in breath - at rest. Range N/A

Time frame: 7 weeks

Chalder Fatigue Score

Questionnaire. Range 0-33. Greater worse

Data from ClinicalTrials.gov

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