Respiratory DiseaseSingstrongNCT04266951
Singstrong: Singing for Better Lung Health
A study testing Singstrong: in people with Respiratory Disease and COPD, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease, COPD
- What is being tested?
- Singstrong:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Apr 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lack of a clinical diagnosis of COPD
- Presence of physical of psychological co-morbidities precluding participation in either testing or intervention.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Respiratory Disease, COPD
- Being tested
- Singstrong:
- Medical subject headings
- Respiration Disorders, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singstrong:Behavioural
Group singing and breathing control training
| Study group | Role | What they receive |
|---|---|---|
| Group singing and breathing control training | Other | Not described Receives: Behavioral: Singstrong: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient anxiety and depression
Hospital Anxiety and Depression Scale (HADS). This questionnaire is widely used to measure anxiety and depression in a general medical population of patients. The questionnaire features seven questions for anxiety and seven for depression of which can be answered within 2 - 5 minutes. Each item is scored from 0-3 with a higher score indicating a greater presence of either anxiety or depression. Maximal (worst) score for either factor is 21.
Measured: 8 weeks
Functional capacity
Six minute walk test (6MWT). The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. This is measured in metres with levels of oxygen saturation and heart rate pre and post the test also recorded.
Measured: 8 weeks
Disease impact
COPD Assessment test (CAT). The CAT is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. This is a patient-completed questionnaire assessing all aspects of the impact of COPD (cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels) There are 8 questions on a 1 to 5 point scale. A higher score indicates more disease impact. Max score is 40.
Measured: 8 weeks
Secondary outcomes (2)
Lung function
Spirometry: The main measures recorded will include FEV1, or forced expiratory volume, is a measurement taken from a pulmonary function test. It calculates the amount of air that a person can force out of their lungs in 1 second.FVC, or Forced Vital Capacity, refers to the total amount of air that a person can exhale, will also be recorded. The ration of FEV1/FVC will also be recorded, as this provided an objective measure of the presence of disease. FEV1/FVC < 0.70). Disease severity in persons below a ratio of 0.7 is indicated by the value of FEV1. Mild FEV1 ≥ 80% predicted, Moderate 50% ≤ FEV1 < 80% predicted, Severe 30% ≤ FEV1 < 50% predicted, Very Severe FEV1 < 30% predicted.
Measured: 8 weeks
Qualitative evaluation of intervention
Focus Groups: Focus group interviews with participants from each of the three choirs will be conducted to establish the effectiveness of the intervention, to establish what went well, and points for improvement in further iterations. Focus groups will be comprised of between 5 and 8 people, with a semi-structured design.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Apr 2019
- Primary completion31 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study: Pre and post intervention with a single patient cohort.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Research Council
- Responsible party
- Sponsor
- Investigators
- Roisin Cahalan, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266951
- Sponsor's protocol ID
- NF1
- Acronym
- Singstrong
- Status last verified
- Jan 2025
- First submitted
- 14 Jun 2019
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singstrong: Singing for Better Lung Health
- ClinicalTrials.gov ID
- NCT04266951
- Acronym / sponsor ID
- Singstrong / NF1
- Conditions
- Respiratory Disease, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Irish Research Council
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study: Pre and post intervention with a single patient cohort.
| Arm | Type | Receives |
|---|---|---|
| Group singing and breathing control training | Other | Behavioral: Singstrong: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Lack of a clinical diagnosis of COPD
- Presence of physical of psychological co-morbidities precluding participation in either testing or intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singstrong:Group singing and breathing control training | Behavioural | Group singing and breathing control training |
Primary outcome
Patient anxiety and depression
Time frame: 8 weeks
Hospital Anxiety and Depression Scale (HADS). This questionnaire is widely used to measure anxiety and depression in a general medical population of patients. The questionnaire features seven questions for anxiety and seven for depression of which can be answered within 2 - 5 minutes. Each item is scored from 0-3 with a higher score indicating a greater presence of either anxiety or depression. Maximal (worst) score for either factor is 21.
Functional capacity
Time frame: 8 weeks
Six minute walk test (6MWT). The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. This is measured in metres with levels of oxygen saturation and heart rate pre and post the test also recorded.
Disease impact
Time frame: 8 weeks
COPD Assessment test (CAT). The CAT is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. This is a patient-completed questionnaire assessing all aspects of the impact of COPD (cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels) There are 8 questions on a 1 to 5 point scale. A higher score indicates more disease impact. Max score is 40.
2 secondary outcomes
Lung function
Time frame: 8 weeks
Qualitative evaluation of intervention
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roisin Cahalan, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singstrong: in people with Respiratory Disease and COPD, run by University of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient anxiety and depression (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.