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

NCT06503913 | Completed

• 1 other identifier: 0186
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID; Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 Self-evaluation of breathing 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 EQ-5D-5L

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

Study Arms (1)

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.

Behavioral: Cognitive Muscular Therapy; Behavioral: Breathing visualisation

Interventions

Cognitive Muscular Therapy BEHAVIORAL

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

Treatment

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

University of Salford

Manchester, Greater Manchester, M6 6PU, United Kingdom

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Respiration Disorders

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 16, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)