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

University of Nottingham

Status: Active, not recruiting

Conditions: COVID-19; Respiratory Disease

Treatments: Other: Breathing techniques over 12 sessions / 6 weeks inc yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT05732571

Post COVID-19 REMEDY (Other Identifier)

22023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Breathing Techniques Intervention

Active Comparator group

Description:

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.

Treatment:

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

Usual Care

No Intervention group

Description:

A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.