Post COVID-19 REspiratory Mechanisms and the Efficacy of... | NCT05732571

Studies
Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing

NCT05732571

Sponsor

University of Nottingham

Status

Completed

Last Update Posted

May 4, 2026Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

COVID-19
Respiratory Disease

Interventions

Breathing techniques over 12 sessions / 6 weeks inc yoga

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Post COVID-19 REMEDY	Other Identifier	University of Nottingham

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

May 20, 2022

First Submission Date that Met QC Criteria

Feb 16, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A pilot Study

To investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following COVID-19 when compared to usual care.

Detailed Description

Pilot RCT for upto 60 subjects across 2 arms

Intervention A 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. Each group will aim for between 3- 6 participants.

Each online session will be circa 40-50 minutes in length. This will include an Introduction and warm up; Breathing practice including yogic breathing and a final cool down and relaxation.

Sessions will run at set times to ensure efficient use of resources but will try to accommodate different time points periods of the day when patients might be functioning best.

Comparator A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.

Primary co-outcomes

Change in

Breathlessness: Chronic Respiratory Disease Questionnaire-Dyspnoea domain (CRQ-D)
Functional measure: 5 repetition chair to stand (5RCTS)

Secondary measures include other measures of breathlessness, function, adherence and completion (see full text for detail).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breathing Techniques Intervention	Active Comparator	A 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. Each group will aim for between 3- 6 participants.	Other: Breathing techniques over 12 sessions / 6 weeks inc yoga
Usual Care	No Intervention	A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breathing techniques over 12 sessions / 6 weeks inc yoga	Other	as above	Breathing Techniques Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breathlessness.	Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse	7 weeks
Function	5 repetition chair to stand. Range 0-120 seconds with longer worse	7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Dyspnoea-12 Questionnaire	SOB questionnaire. Range 0-36, Greater, worse	7 weeks
Nijmegen Questionnaire	Measure of dysregulated breathing. 0-64. Greater worse

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Either hospitalised or non-hospitalised with confirmed COVID-19 acute infection.
Received a comprehensive clinical respiratory assessment
Persisting (>12 weeks) self-reported breathlessness (on CRQ-D) following COVID-19 and confirmed dysregulated breathing (Nijmegen Questionnaire score NQ >23)
Age 18 - 80 years of age
Ability to give informed consent
Able to understand and speak English language

Exclusion Criteria:

Severe mood disturbance that limits engagement with the intervention and study outcomes
No access to online delivery and/or IT illiterate
Significant diagnosed Myalgic Encephalitis/Fibromyalgia/Chronic Fatigue Syndrome prior to developing COVID-19
Severe asthma or other chronic lung disease prior to COVID-19

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlotte Bolton	University of Nottingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nottingham University Hospitals Trust		Nottingham	Notts	NG5 1PB	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

This is pilot to generate a more formal plan

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D012120	Respiration Disorders

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

Randomisation will be completed in a 1:1 ratio (Intervention: Usual Care) using a sealed envelope block randomisation process.

The study will be single blinded and controlled through the use of a distinct intervention team and an outcomes team.

The intervention team will manage the randomisation and intervention session and planning. The outcomes team will be blinded to the intervention or usual care.

Who Masked

Outcomes Assessor