Clinical trial NCT04266951: Singstrong: Singing for Better Lung Health
Official title: Singstrong: Singing for Better Lung Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Disease
COPD
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Irish Research Council
First posted: 2020-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study: Pre and post intervention with a single patient cohort.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Participants must have an existing diagnosis of COPD according to recognised diagnostic criteria, must be clinically stable, and not have suffered an exacerbation in the 2 weeks prior to testing.
* All participants must be at least 18 years of age. There is no upper age limit.
* Participants may be male or female.
* They must have a good command of written and spoken English.

Exclusion Criteria:

* Lack of a clinical diagnosis of COPD
* Presence of physical of psychological co-morbidities precluding participation in either testing or intervention.

Primary outcomes:
measure: Patient anxiety and depression
timeFrame: 8 weeks
measure: Functional capacity
timeFrame: 8 weeks
measure: Disease impact
timeFrame: 8 weeks
Secondary outcomes:
measure: Lung function
timeFrame: 8 weeks
measure: Qualitative evaluation of intervention
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
Study officials:
affiliation: University of Limerick
name: Roisin Cahalan, PhD
role: PRINCIPAL_INVESTIGATOR
References: