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SingStrong: Strong Lungs Through Song - Long COVID-19 Study (ss)

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ClinicalTrials.gov Identifier: NCT04810065
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Roisin Cahalan, University of Limerick

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.

Condition or disease Intervention/treatment Phase
Long Covid Other: SingStrong: Strong lungs through Song Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SingStrong: Strong Lungs Through Song
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
SingStrong for Pulmonary Fibrosis

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

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,





Primary Outcome Measures :
  1. Covid-19 Yorkshire Rehab Screen (C19YRS) [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. DePaul Symptom Questionnaire - Short Form DSQ - SF [ Time Frame: 12 weeks ]
    The DPSQ -SF assesses key symptoms of ME/Chronic Fatigue Syndrome such as fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. A higher score denotes increased symptom severity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810065


Contacts
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Contact: Roisin Cahalan, PhD +35361 202959 roisin.cahalan@ul.ie

Locations
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Ireland
University of Limerick Recruiting
Limerick, Ireland
Contact: Roisin Cahalan, PhD         
Sponsors and Collaborators
University of Limerick
Investigators
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Principal Investigator: Roisin Cahalan, PhD University of Limerick
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Responsible Party: Roisin Cahalan, Senior Lecturer Physiotherapy, University of Limerick
ClinicalTrials.gov Identifier: NCT04810065    
Other Study ID Numbers: SingStrong
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roisin Cahalan, University of Limerick:
Singing
Disordered breathing
Covid-19