History of Changes for Study: NCT04810065

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

Latest version (submitted September 27, 2021) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	March 19, 2021	None (earliest Version on record)
2	April 9, 2021	Study Status, Arms and Interventions, Outcome Measures, Conditions, Study Description and Study Identification
3	September 27, 2021	Recruitment Status, Study Status, Contacts/Locations and Study Design

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Study NCT04810065
Submitted Date: March 19, 2021 (v1)

Study Identification


Unique Protocol ID:	SingStrong
Brief Title:	SingStrong: Strong Lungs Through Song Long COVID Study (ss)
Official Title:	SingStrong: Strong Lungs Through Song
Secondary IDs:

Study Status


Record Verification:	March 2021
Overall Status:	Recruiting
Study Start:	March 29, 2021
Primary Completion:	July 2021 [Anticipated]
Study Completion:	September 30, 2021 [Anticipated]

First Submitted:	March 19, 2021
First Submitted that Met QC Criteria:	March 19, 2021
First Posted:	March 22, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	March 19, 2021
Last Update Posted:	March 22, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	University of Limerick
Responsible Party:	Principal Investigator Investigator: Roisin Cahalan Official Title: Senior Lecturer Physiotherapy Affiliation: University of Limerick
Collaborators:

Study Description

Brief Summary:

Evidence is emerging that many individuals who recover from Covid19 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.

Detailed Description:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
Number of Arms:
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	35 [Anticipated]

Arms and Interventions


Intervention Details:
	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,

Outcome Measures


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

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
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

Contacts/Locations


Central Contact Person:	Roisin Cahalan, PhD Telephone: +35361 202959 Email: roisin.cahalan@ul.ie
Study Officials:	Roisin Cahalan, PhD Principal Investigator University of Limerick
Locations:	Ireland
	University of Limerick [Recruiting] Limerick, Ireland Contact:Contact: Roisin Cahalan, PhD

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