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

NCT ID: NCT06503913

Last Updated: 2025-12-02

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Long COVID Respiratory Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Muscular Therapy

Intervention Type BEHAVIORAL

Psychologically informed physiotherapy which integrates training to reduce overactivity of postural muscles which can interfere with the mechanics of breathing.

Breathing visualisation

Intervention Type 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.

Interventions

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Cognitive Muscular Therapy

Psychologically informed physiotherapy which integrates training to reduce overactivity of postural muscles which can interfere with the mechanics of breathing.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Salford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Salford

Manchester, Greater Manchester, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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0186

Identifier Type: -

Identifier Source: org_study_id

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