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Clinical Trials/NCT06503913
NCT06503913
Active, not recruiting
Not Applicable

Cognitive Muscular Therapy for Patients With Long-COVID (Post COVID-19) and Breathing Pattern Disorder

University of Salford1 site in 1 country20 target enrollmentAugust 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Long COVID
Sponsor
University of Salford
Enrollment
20
Locations
1
Primary Endpoint
Change in Nijmegen Questionnaire
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
April 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Change in Nijmegen Questionnaire

Time Frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)

Used to capture breathlessness symptoms associated with hyperventilation disorder. Score 0 - 60 (0 = no hyperventilation symptoms, 60 severe symptoms of hyperventilation).

Secondary Outcomes

  • Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in Dyspnea-12 questionnaire(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in Composite Autonomic Symptom Score(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in Self-evaluation of breathing questionnaire(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in EQ-5D-5L(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))
  • Change in WHO Disability Assessment Schedule (12-item)(Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention))

Study Sites (1)

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