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

Not Applicable

Active, not recruiting

• Conditions: Respiratory Disease; COVID-19
• Interventions: Other: Breathing techniques over 12 sessions / 6 weeks inc yoga

• Registration Number: NCT05732571
• Lead Sponsor: University of Nottingham

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).

Study Timeline

• Study First Submitted: 2022-05-20
• Study Start: 2023-02-10
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathing Techniques Intervention	Breathing techniques over 12 sessions / 6 weeks inc yoga	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Chalder Fatigue Score	7 weeks	Questionnaire. Range 0-33. Greater worse
Borg Scale of Breathlessness	7 weeks	Measure of breathlessness. Range 0-10. Greater worse
Capnography - in some volunteers	7 weeks	End tidal CO2 measure in breath - at rest. Range N/A
Dyspnoea-12 Questionnaire	7 weeks	SOB questionnaire. Range 0-36, Greater, worse
Modified Minnesota Physical Activity	7 weeks	Questionnaire. Range 0-100. Greater better.
Four metre Gait speed	7 weeks	field test of physical performance. Range 0-60seconds. 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
Nijmegen Questionnaire	7 weeks	Measure of dysregulated breathing. 0-64. Greater worse

Trial Locations

Locations (1)

Nottingham University Hospitals Trust; 🇬🇧 Nottingham, Notts, United Kingdom