Long COVIDCOMLOCNCT06503913
Cognitive Muscular Therapy for Patients With Long-COVID and Breathing Pattern Disorder
A study testing Cognitive Muscular Therapy and Breathing visualisation in people with Long COVID and Respiratory Disease, run by University of Salford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Respiratory Disease
- What is being tested?
- Cognitive Muscular Therapy and Breathing visualisation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Salford
Manchester, Greater Manchester, M6 6PU
About this study
Official title: 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.
Read the 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
- Conditions
- Long COVID, Respiratory Disease
- Being tested
- Cognitive Muscular Therapy, Breathing visualisation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Muscular TherapyBehavioural
Psychologically informed physiotherapy which integrates training to reduce overactivity of postural muscles which can interfere with the mechanics of breathing.
Breathing visualisationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Muscular Therapy; Behavioral: Breathing visualisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503913
- Sponsor's protocol ID
- 0186
- Acronym
- COMLOC
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Muscular Therapy for Patients With Long-COVID (Post COVID-19) and Breathing Pattern Disorder
- ClinicalTrials.gov ID
- NCT06503913
- Acronym / sponsor ID
- COMLOC / 0186
- Conditions
- Long COVID, Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Cognitive Muscular Therapy, Behavioral: Breathing visualisationEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Muscular TherapyPsychologically informed physiotherapy which integrates training to reduce overactivity of postural muscles which can interfere with the mechanics of breathing. | Behavioural | Treatment |
| Breathing visualisationBreathing 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. | Behavioural | Treatment |
Primary outcome
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).
6 secondary outcomes
Change in Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale
Time frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Change in Dyspnea-12 questionnaire
Time frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Change in Self-evaluation of breathing questionnaire
Time frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Change in Composite Autonomic Symptom Score
Time frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Change in EQ-5D-5L
Time frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Change in WHO Disability Assessment Schedule (12-item)
Time frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. no data sharing plan
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Muscular Therapy and Breathing visualisation in people with Long COVID and Respiratory Disease, run by University of Salford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nijmegen Questionnaire (time frame: Change from Baseline to two months (post intervention) & change from Baseline to 5 months (post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.