Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-01 @ 1:39 PM
Study NCT ID:
NCT04266951
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2019-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Singstrong: Singing for Better Lung Health
Sponsor:
University of Limerick
Organization:
Study Overview
Official Title:
Singstrong: Singing for Better Lung Health
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Singstrong
Brief Summary:
Chronic Obstructive Pulmonary Disease (COPD) is a pervasive, insidious condition associated with catastrophic socioeconomic, healthcare and personal implications. This proposal outlines how a group singing intervention, led by clinical personnel and a community singing leader, can address these challenges. Built upon existing ties between the Principal Investigator (PI) and local COPD support group, this project is co-designed by patients and clinicians. Modelled on similar interventions internationally, this project is pioneering in Ireland. Outputs will include a participant-led symposium and three community COPD choirs, in addition to a number of academic publications. This project is funded by the Irish Research Council (IRC) "New Foundations" scheme.
Detailed Description:
Brief Background:
Approximately 440,000 Irish people suffer from Chronic Obstructive Pulmonary Disease (COPD) (Health Service Executive (HSE), 2018) and it is the fourth most common cause of death, after lung cancer, heart disease and stroke. In addition to many physical issues, patients lack the physical endurance or confidence to participate fully in their lives, leading to isolation, social exclusion and co-morbid depression and anxiety. Addressing the management of people with COPD was highlighted as an urgent priority in the Government's 2017 National Healthcare Quality Reporting System annual report. This application proposes a community-based singing intervention replicating that successfully delivered by the British Lung Foundation (BLF) (https://www.blf.org.uk/support-for-you/singing-for-lung-health). This project is unique in Ireland, and builds on established ties between the (Principal Investigator) PI and the local COPD community. It is supported by COPD Support Ireland.
Study design:
* This study is a pre-post intervention study involving a cohort of COPD patients who are members of regional COPD support groups in Limerick, Ennis and Nenagh.
* Pre-intervention testing will involve self-reported measures wellness using standardised tools as well as a walking test (6-minute walking test (6MWT) and spirometry to asses lung function.
* The intervention is an eight-week singing intervention led by an experienced singing instructor who will be provided with relevant training on singing with lung impairment. Participants will also be provided with a compact disk (CD) for between intervention practice at their own discretion.
* Post-intervention testing will repeat tests done at baseline. Testing will be carried out in both instances by the PI and clinical staff from the geographical area.
Focus groups will be conducted with a sample from each group to support a qualitative evaluation of the intervention.
Participants:
Approximately 30 participants from each region will be invited to participate. Participants must have a diagnosis of COPD, must be clinically stable, and not have suffered an exacerbation in the 2 weeks prior to testing.
Participants have been sourced through the clinicians involved in this study, and the teaching contacts of the PI.
Procedures/Methods :
Planing stage: April/May 2019
* Community singing leader will attend United Kingdom (UK) training course delivered by BLF "Singing for Lung Health" leaders. - Liaise with three regional COPD patient groups (Limerick, Ennis, Nenagh) to gather informed consent, and finalise intervention details.
* Design and record CD featuring exercises and songs for home practice for participants. These will be provided freely to participants and based on song preference of patient-partners, and informed by disease limiting factors.
* Baseline testing of participants as discussed will take place in a community setting where the groups normally meet for other exercise and social activities.
Intervention stage: June/July 2019
* The intervention will comprise eight weekly one-hour singing sessions. Sessions will be comprised of physical warm-ups, breathing exercises, and vocal exercises such as rhythm and pitch games.
* The intervention will be delivered by the community singing leader and the PI will attend the first session to explain the clinical relevance of exercises.
Approximately 440,000 Irish people suffer from Chronic Obstructive Pulmonary Disease (COPD) (Health Service Executive (HSE), 2018) and it is the fourth most common cause of death, after lung cancer, heart disease and stroke. In addition to many physical issues, patients lack the physical endurance or confidence to participate fully in their lives, leading to isolation, social exclusion and co-morbid depression and anxiety. Addressing the management of people with COPD was highlighted as an urgent priority in the Government's 2017 National Healthcare Quality Reporting System annual report. This application proposes a community-based singing intervention replicating that successfully delivered by the British Lung Foundation (BLF) (https://www.blf.org.uk/support-for-you/singing-for-lung-health). This project is unique in Ireland, and builds on established ties between the (Principal Investigator) PI and the local COPD community. It is supported by COPD Support Ireland.
Study design:
* This study is a pre-post intervention study involving a cohort of COPD patients who are members of regional COPD support groups in Limerick, Ennis and Nenagh.
* Pre-intervention testing will involve self-reported measures wellness using standardised tools as well as a walking test (6-minute walking test (6MWT) and spirometry to asses lung function.
* The intervention is an eight-week singing intervention led by an experienced singing instructor who will be provided with relevant training on singing with lung impairment. Participants will also be provided with a compact disk (CD) for between intervention practice at their own discretion.
* Post-intervention testing will repeat tests done at baseline. Testing will be carried out in both instances by the PI and clinical staff from the geographical area.
Focus groups will be conducted with a sample from each group to support a qualitative evaluation of the intervention.
Participants:
Approximately 30 participants from each region will be invited to participate. Participants must have a diagnosis of COPD, must be clinically stable, and not have suffered an exacerbation in the 2 weeks prior to testing.
Participants have been sourced through the clinicians involved in this study, and the teaching contacts of the PI.
Procedures/Methods :
Planing stage: April/May 2019
* Community singing leader will attend United Kingdom (UK) training course delivered by BLF "Singing for Lung Health" leaders. - Liaise with three regional COPD patient groups (Limerick, Ennis, Nenagh) to gather informed consent, and finalise intervention details.
* Design and record CD featuring exercises and songs for home practice for participants. These will be provided freely to participants and based on song preference of patient-partners, and informed by disease limiting factors.
* Baseline testing of participants as discussed will take place in a community setting where the groups normally meet for other exercise and social activities.
Intervention stage: June/July 2019
* The intervention will comprise eight weekly one-hour singing sessions. Sessions will be comprised of physical warm-ups, breathing exercises, and vocal exercises such as rhythm and pitch games.
* The intervention will be delivered by the community singing leader and the PI will attend the first session to explain the clinical relevance of exercises.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: