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

Sponsor

University of Nottingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT05732571

Collaborator

(none)

Enrollment

Location

Arms

16.6

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Disease	Other: Breathing techniques over 12 sessions / 6 weeks inc yoga	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A single site, pilot RCT of intervention compared to usual careA single site, pilot RCT of intervention compared to usual care

Masking:

Single (Outcomes Assessor)

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 10, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Dyspnoea-12 Questionnaire [7 weeks]
SOB questionnaire. Range 0-36, Greater, worse
Nijmegen Questionnaire [7 weeks]
Measure of dysregulated breathing. 0-64. Greater worse
Borg Scale of Breathlessness [7 weeks]
Measure of breathlessness. Range 0-10. Greater worse
Four metre Gait speed [7 weeks]
field test of physical performance. Range 0-60seconds. Greater worse
Modified Minnesota Physical Activity [7 weeks]
Questionnaire. Range 0-100. Greater better.
Capnography - in some volunteers [7 weeks]
End tidal CO2 measure in breath - at rest. Range N/A
Chalder Fatigue Score [7 weeks]
Questionnaire. Range 0-33. Greater worse
EQ5D Quality of Life score [7 weeks]
Questionnaire. VAS 0-100. Greater is better.
Adherence [7 weeks]
Recorded from number of potential sessions. Range 0-12. Greater better.
Breath hold, Respiratory rate [7 weeks]
Observational measures at rest. Breath hold - 0-45. Greater better. RR. Range 0-30. Greater worse

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nottingham University Hospitals Trust	Nottingham	Notts	United Kingdom	NG5 1PB

Sponsors and Collaborators

University of Nottingham

Investigators

Principal Investigator: Charlotte Bolton, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Nottingham

ClinicalTrials.gov Identifier:

NCT05732571

Other Study ID Numbers:

22023
Post COVID-19 REMEDY

First Posted:

Feb 17, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Respiratory Aspiration

Respiration Disorders

Respiratory Tract Diseases

Study Results

No Results Posted as of Feb 21, 2023