Clinical trial NCT05732571: Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing
Official title: Post COVID REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing (REMEDY): COVID-19
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COVID-19
Respiratory Disease
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single site, pilot RCT of intervention compared to usual care
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Breathlessness.
timeFrame: 7 weeks
measure: Function
timeFrame: 7 weeks
Secondary outcomes:
measure: Dyspnoea-12 Questionnaire
timeFrame: 7 weeks
measure: Nijmegen Questionnaire
timeFrame: 7 weeks
measure: Borg Scale of Breathlessness
timeFrame: 7 weeks
measure: Four metre Gait speed
timeFrame: 7 weeks
measure: Modified Minnesota Physical Activity
timeFrame: 7 weeks
measure: Capnography - in some volunteers
timeFrame: 7 weeks
measure: Chalder Fatigue Score
timeFrame: 7 weeks
measure: EQ5D Quality of Life score
timeFrame: 7 weeks
measure: Adherence
timeFrame: 7 weeks
measure: Breath hold, Respiratory rate
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals Trust
state: Notts
Study officials:
affiliation: University of Nottingham
name: Charlotte Bolton
role: PRINCIPAL_INVESTIGATOR
References: