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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Disease; Long COVID
• Intervention / Treatment: Behavioral: Cognitive Muscular Therapy; Behavioral: Breathing visualisation

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M6 6PU
      • University of Salford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; 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.

Behavioral: Cognitive Muscular Therapy; Psychologically informed physiotherapy which integrates training to reduce overactivity of postural muscles which can interfere with the mechanics of breathing.; Behavioral: Breathing visualisation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: University of Salford

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome; Respiration Disorders
• Other Study ID Numbers: 0186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no data sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No