Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing
NCT ID: NCT05732571
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-02-10
2024-07-30
Brief Summary
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To investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following COVID-19 when compared to usual care.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
The study will be single blinded and controlled through the use of a distinct intervention team and an outcomes team.
The intervention team will manage the randomisation and intervention session and planning. The outcomes team will be blinded to the intervention or usual care.
Study Groups
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Breathing Techniques 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.
Breathing techniques over 12 sessions / 6 weeks inc yoga
as above
Usual Care
A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.
No interventions assigned to this group
Interventions
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Breathing techniques over 12 sessions / 6 weeks inc yoga
as above
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Charlotte Bolton
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Nottingham University Hospitals Trust
Nottingham, Notts, United Kingdom
Countries
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Other Identifiers
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Post COVID-19 REMEDY
Identifier Type: OTHER
Identifier Source: secondary_id
22023
Identifier Type: -
Identifier Source: org_study_id
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