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

COVID-19 Clinical Trial

— REMEDY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05732571
• Other study ID #: 22023
• Secondary ID: Post COVID-19 RE
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 30, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Other:
• Breathing techniques over 12 sessions / 6 weeks inc yoga
as above

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals Trust	Nottingham	Notts

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathlessness.	Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse	7 weeks
Primary	Function	5 repetition chair to stand. Range 0-120 seconds with longer worse	7 weeks
Secondary	Dyspnoea-12 Questionnaire	SOB questionnaire. Range 0-36, Greater, worse	7 weeks
Secondary	Nijmegen Questionnaire	Measure of dysregulated breathing. 0-64. Greater worse	7 weeks
Secondary	Borg Scale of Breathlessness	Measure of breathlessness. Range 0-10. Greater worse	7 weeks
Secondary	Four metre Gait speed	field test of physical performance. Range 0-60seconds. Greater worse	7 weeks
Secondary	Modified Minnesota Physical Activity	Questionnaire. Range 0-100. Greater better.	7 weeks
Secondary	Capnography - in some volunteers	End tidal CO2 measure in breath - at rest. Range N/A	7 weeks
Secondary	Chalder Fatigue Score	Questionnaire. Range 0-33. Greater worse	7 weeks
Secondary	EQ5D Quality of Life score	Questionnaire. VAS 0-100. Greater is better.	7 weeks
Secondary	Adherence	Recorded from number of potential sessions. Range 0-12. Greater better.	7 weeks
Secondary	Breath hold, Respiratory rate	Observational measures at rest. Breath hold - 0-45. Greater better. RR. Range 0-30. Greater worse	7 weeks