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Completed

NCT Number: NCT05732571

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals Trust

Nottingham, Notts, NG5 1PB, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathing techniques over 12 sessions / 6 weeks inc yoga

Other

as above

Primary outcomes

  1. Breathlessness.

    Time frame: 7 weeks

    Chronic Respiratory Disease Questionnaire - Dyspnoea Domain Range 1-7 with lower - worse

  2. Function

    Time frame: 7 weeks

    5 repetition chair to stand. Range 0-120 seconds with longer worse

Secondary outcomes

  1. Dyspnoea-12 Questionnaire

    Time frame: 7 weeks

    SOB questionnaire. Range 0-36, Greater, worse

  2. Nijmegen Questionnaire

    Time frame: 7 weeks

    Measure of dysregulated breathing. 0-64. Greater worse

  3. Borg Scale of Breathlessness

    Time frame: 7 weeks

    Measure of breathlessness. Range 0-10. Greater worse

  4. Four metre Gait speed

    Time frame: 7 weeks

    field test of physical performance. Range 0-60seconds. Greater worse

  5. Modified Minnesota Physical Activity

    Time frame: 7 weeks

    Questionnaire. Range 0-100. Greater better.

  6. Capnography - in some volunteers

    Time frame: 7 weeks

    End tidal CO2 measure in breath - at rest. Range N/A

  7. Chalder Fatigue Score

    Time frame: 7 weeks

    Questionnaire. Range 0-33. Greater worse

  8. EQ5D Quality of Life score

    Time frame: 7 weeks

    Questionnaire. VAS 0-100. Greater is better.

  9. Adherence

    Time frame: 7 weeks

    Recorded from number of potential sessions. Range 0-12. Greater better.

  10. Breath hold, Respiratory rate

    Time frame: 7 weeks

    Observational measures at rest. Breath hold - 0-45. Greater better. RR. Range 0-30. Greater worse

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: REMEDY

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 17, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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