NCT04810065

Brief Summary

Evidence is emerging that many individuals who recover from Covid-19 are experiencing a range of residual problems. These include fatigue, pain, reduced exercise tolerance and breathing issues. This study includes participants who are experiencing problems with their lungs such as breathing difficulties, shortness of breath, and/or reduced exercise tolerance. The intervention is a twice weekly singing and breathing retraining intervention conducted over ten weeks. A range of self-report questionnaire measures will evaluate the efficacy of the intervention in addressing these problems. Focus groups and individual interviews will also be used to gather information on the impact and acceptability of the programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 29, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

March 19, 2021

Last Update Submit

September 27, 2021

Conditions

Keywords

SingingDisordered breathingCovid-19

Outcome Measures

Primary Outcomes (1)

  • Covid-19 Yorkshire Rehab Screen (C19YRS)

    The C19YRS was developed as a screening tool to monitor long-term symptoms due to Covid-19. The screening tool covers 19 items which combines yes/no answers and an 11 point ordinal scale (0-10) where a higher score denotes increased symptom severity.

    12 weeks

Secondary Outcomes (1)

  • DePaul Symptom Questionnaire - Short Form DSQ - SF

    12 weeks

Study Arms (1)

SingStrong for Pulmonary Fibrosis

OTHER

This arm of the project explores Singing as an intervention for people suffering from Pulmonary Fibrosis specifically. It is a 10 week programme. All other aspects of the intervention are the same in terms of delivery and length of classes. Different outcome measures, namely the St Georges Respiratory Questionnaire is used in this trial. This is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

Other: SingStrong: Strong lungs through Song

Interventions

Participants who have been clinically diagnosed with Covid-19 and who continue to suffer residual adverse effects on the lung health will be invited to participate in the study. The intervention will involve biweekly hour-long breathing and singing classes that are designed to correct dis-ordered breathing, and retrain the principal muscles of respiration. Pre and post evaluation of participant bio-psychosocial health and wellness will be conducted. Triangulation of data using focus groups and individual interviews will be conducted after conclusion of the intervention,

SingStrong for Pulmonary Fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Previous clinical diagnosis of Covid-19
  • Ongoing issues with any or all of: Shortness of breath, disordered breathing, reduced exercise tolerance
  • Good written and spoken English language

You may not qualify if:

  • Lack of a confirmed Covid-19 diagnosis
  • Currently undergoing a similar singing or breathing retraining intervention
  • No residual problems from a confirmed case of Covid-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Limerick

Limerick, Ireland

Location

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roisin Cahalan, PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer Physiotherapy

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 22, 2021

Study Start

March 29, 2021

Primary Completion

July 29, 2021

Study Completion

September 1, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations