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The aim of the study is to test a treatment known as "Cognitive Muscular Therapy (CMT)" for reducing breathlessness and improving autonomic function in patients with long-COVID.
A key symptom of long-COVID is dysfunctional breathing, characterised by an alteration in the muscular and mechanical control of breathing, such as altered movement/coordination of diaphragm and ribs. Long-COVID patients also experience symptoms such as dizziness and fatigue, which have been linked to dysautonomia (dysfunction of the nervous system controlling automatic body functions). Importantly, dysautonomia is connected to alterations in breathing mechanics. Specifically, rapid breathing, high in the chest, is associated with increased activity in the fight-or-flight system and decreased activity in the rest-and-repair system. Given this link, interventions capable of improving breathing mechanics could alleviate many long-COVID symptoms. However, current breathing retraining methods lack visualisation of breathing mechanics and do not integrate a whole-body approach to improving postural control.
We have developed a clinical system which can visualise breathing mechanics in real-time, providing patients with a "window into their body". We propose to integrate this system within a new intervention, known as Cognitive Muscular Therapy (CMT). CMT integrates psychological informed physiotherapy with training to reduce overactivation of postural muscles which can interfere with the mechanics of breathing. We propose to test this combined intervention on 20 people with Long-COVD to understand if we can improve respiratory function and symptoms associated with dysautonomia. If successful, this pilot study could pave the way for large-scale studies in long-COVID
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Each participant will receive seven weekly sessions of Cognitive Muscular Therapy (CMT) + Breathing Visualisation at the University of Salford from an respiratory physiotherapist. This physiotherapist will have been trained to deliver the CMT intervention and will have at least three years' experience of working with patients with respiratory disorders. Each treatment session will last 45-60 mins. The CMT intervention comprises five components: Understanding long-COVID, general relaxation, postural deconstruction, contextual triggers and functional integration. Breathing Visualisation will be integrated into session 5, 6 and 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Muscular Therapy | Behavioral | Psychologically informed physiotherapy which integrates training to reduce overactivity of postural muscles which can interfere with the mechanics of breathing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nijmegen Questionnaire | Used to capture breathlessness symptoms associated with hyperventilation disorder. Score 0 - 60 (0 = no hyperventilation symptoms, 60 severe symptoms of hyperventilation). | Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale | Used to capture breathlessness symptoms associated with long-COVID compared to pre-acute infection. Score 0 - 45 (0 = no long-COVID symptoms, 45 severe symptoms of long-COVID). | Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Salford | Manchester | Greater Manchester | M6 6PU | United Kingdom |
no data sharing plan
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Breathing visualisation | Behavioral | Breathing visualisation; Data from two 3D camera are combined and used to calculate respiratory volumes. These volumes are then used to drive an animation of breathing so that the patient can understand how their breathing pattern compares to an optimal pattern. Note this is not a medical device as data from this system is only used for education and not for diagnostic or treatment decisions. |
|
| Change in Dyspnea-12 questionnaire | Used to capture breathlessness symptoms. Score 0 - 36 (0 = no breathlessness symptoms, 36 severe breathlessness). | Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention) |
| Change in Self-evaluation of breathing questionnaire | Used to capture breathlessness symptoms associated with dysfunctional breathing. Score 0 - 75 (0 = no dysfunctional breathing symptoms, 60 severe symptoms of dysfunctional breathing). | Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention) |
| Change in Composite Autonomic Symptom Score | Used to capture symptoms associated with autonomic dysfunction. 31 questions rating the symptoms associated with autonomic dysfunction. | Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention) |
| Change in EQ-5D-5L | Used to capture an individual's quality of life through their ability to complete daily living activities. Each heading is rated from no problems through to unable to complete the task. | Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention) |
| Change in WHO Disability Assessment Schedule (12-item) | Used to capture an individual's ability to perform daily living activities. Each point is rated from No difficulty performing a task to extreme difficulty/cannot complete the task. | Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention) |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |