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

NCT05732571 | Completed

• 2 other identifiers: 22023Post COVID-19 REMEDY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 (10)

• Dyspnoea-12 Questionnaire

  7 weeks

• Nijmegen Questionnaire

  7 weeks

• Borg Scale of Breathlessness

  7 weeks

• Four metre Gait speed

  7 weeks

• Modified Minnesota Physical Activity

  7 weeks

Study Arms (2)

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

Breathing techniques over 12 sessions / 6 weeks inc yoga OTHER

as above

Breathing Techniques Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham University Hospitals Trust

Nottingham, Notts, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Respiration Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charlotte Bolton

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single site, pilot RCT of intervention compared to usual care

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: February 17, 2023
• Study Start: February 10, 2023
• Primary Completion: December 31, 2023
• Study Completion: November 30, 2024
• Last Updated: May 4, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)