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

SingStrong: Strong Lungs Through Song

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.

Study Overview

• Status: Completed
• Conditions: Long Covid
• Intervention / Treatment: Other: SingStrong: Strong lungs through Song

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland
    • University of Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
DePaul Symptom Questionnaire - Short Form DSQ - SF	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Limerick

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Covid-19; Singing; Disordered breathing
• Other Study ID Numbers: SingStrong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No