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

Post COVID REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated Breathing (REMEDY): COVID-19

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Respiratory Disease
• Intervention / Treatment: Other: Breathing techniques over 12 sessions / 6 weeks inc yoga

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Notts
    • Nottingham, Notts, United Kingdom, NG5 1PB
      • Nottingham University Hospitals Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breathing Techniques 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.	Other: Breathing techniques over 12 sessions / 6 weeks inc yoga; as above
No Intervention: Usual Care; A six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	7 weeks
Borg Scale of Breathlessness	Measure of breathlessness. Range 0-10. Greater worse	7 weeks
Four metre Gait speed	field test of physical performance. Range 0-60seconds. Greater worse	7 weeks
Modified Minnesota Physical Activity	Questionnaire. Range 0-100. Greater better.	7 weeks
Capnography - in some volunteers	End tidal CO2 measure in breath - at rest. Range N/A	7 weeks
Chalder Fatigue Score	Questionnaire. Range 0-33. Greater worse	7 weeks
EQ5D Quality of Life score	Questionnaire. VAS 0-100. Greater is better.	7 weeks
Adherence	Recorded from number of potential sessions. Range 0-12. Greater better.	7 weeks
Breath hold, Respiratory rate	Observational measures at rest. Breath hold - 0-45. Greater better. RR. Range 0-30. Greater worse	7 weeks

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Charlotte Bolton, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Respiration Disorders
• Other Study ID Numbers: 22023; Post COVID-19 REMEDY (Other Identifier: University of Nottingham)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is pilot to generate a more formal 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