Clinical trial NCT06503913: Cognitive Muscular Therapy for Patients With Long-COVID and Breathing Pattern Disorder
Official title: Cognitive Muscular Therapy for Patients With Long-COVID (Post COVID-19) and Breathing Pattern Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Respiratory Disease
Lead sponsor: University of Salford
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Above 18 years old
* Experience moderate/severe breathlessness, quantified using the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale.
* Speak and understand English sufficiently to read the information sheet and sign the consent form
* Ability to stand without any assistive device for at least 20 minutes (to ensure sufficient capacity to complete the intervention)

Exclusion Criteria:

* Dementia or other major cognitive impairment
* BMI \>32 (as increased subcutaneous fat prevents use of breathing measurement system)
* Current smoker or smoked regularly within last 6 months
* Any cardiorespiratory disease that requires medical intervention (except asthma management)
* Currently receiving physiotherapy-based treatment for LC or breathing pattern disorder
* Significant respiratory co-morbidity (e.g. COPD, uncontrolled Asthma)

Primary outcomes:
measure: Change in Nijmegen Questionnaire
timeFrame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Secondary outcomes:
measure: Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale
timeFrame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
measure: Change in Dyspnea-12 questionnaire
timeFrame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
measure: Change in Self-evaluation of breathing questionnaire
timeFrame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
measure: Change in Composite Autonomic Symptom Score
timeFrame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
measure: Change in EQ-5D-5L
timeFrame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
measure: Change in WHO Disability Assessment Schedule (12-item)
timeFrame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Salford
state: Greater Manchester
Study officials:
References: