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A phase 3 clinical trial examining the effects of SingINg For breathing in chronic obstructive pulmonary disease (COPD) aNd interstitial lung disease (ILD) pAtients

A clinical trial examining the effects of SingINg For breathing on quality of life in COPD aNd ILD pAtients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001280897
Acronym
SINFONIA
Enrollment
140
Registered
2021-09-22
Start date
2022-04-01
Completion date
Unknown
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is being conducted to determine the feasibility, acceptability, and effectiveness of online singing groups as an intervention for wellbeing and symptom management in participants with COPD and interstitial lung disease (ILD) in Australia. Online delivery is important to determine feasibility and acceptability of alternative delivery models to improve accessibility and equity. Previous studies have shown some benefits to singing groups for COPD patients, but no randomized, controlled trials have been conducted in Australia or in participants with ILD. Singing is not anticipated to present risks or adverse effects based on previous cilnical trials and widespread implementation in the UK.

Interventions

Phase 3 is a double-arm, randomised, analysis, mixed-methods intervention study of online singing group classes compared to standard care for participants with lung disease. Arm 1: Intervention – Participation in an online group singing class each week for 12 weeks. Group singing classes will run for 90 minutes and include a warm-up exercise (~15-20 minutes), group singing exercises (~45-60), and a cool-down period (~15-20 minutes). Group singing content will be informed by international singin

Phase 3 is a double-arm, randomised, analysis, mixed-methods intervention study of online singing group classes compared to standard care for participants with lung disease. Arm 1: Intervention – Participation in an online group singing class each week for 12 weeks. Group singing classes will run for 90 minutes and include a warm-up exercise (~15-20 minutes), group singing exercises (~45-60), and a cool-down period (~15-20 minutes). Group singing content will be informed by international singing for lung health interventions and will be modified where required to suit the needs of individual participants. Participants are telephoned monthly to complete study questionnaires and encouraged to optionally sing regularly at home including using the currently available “Singing for breathing” CD developed by Phoene Cave (UK Singing for Lung Health investigator and group leader; description and download available from http://www.themusicalbreath.com/2021/05/13/singing-for-breathing-cd-downloads/). The "Singing for Breathing" CD contains physical warm-ups, breathing exercises, vocal exercises and songs. Attendance in group singing classes will be recorded by the group singing leader and additional use of singing exercises will be recorded during monthly phone reviews. Arm 2: Control – 12 weeks of standard of care. Participants are telephoned monthly to complete study questionnaires. Control arm participants will have the option of enrolling in 12-weeks of free online singing group classes at the completion of the study. No data will be collected for that period. Carer enrolment is optional for both arms of both phases. If enrolled, carers will have the option to participate in singing groups and additional singing at home exercises. Carers will be asked to complete quality of life questionnaires at baseline, 4-weeks, 8-weeks, and 12-weeks.

Sponsors

St Vincents Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient Cohort: 1. Participants with a confirmed diagnosis of COPD or ILD • Diagnosis confirmed on either CT chest scan (within the last 5 years) or lung function testing (within the last 2 years) 2. On stable treatment for at least 4 weeks • Has not started any new or changed existing cardiorespiratory medications (including antibiotics and oral steroids). To be determined by study site clinician. • Has not been admitted to hospital with an exacerbations of their underlying disease (COPD or ILD) within the past 4 weeks. 3. Modified Medical Research Council dyspnoea score grerater than or equal to 2 4. Aged 18 years or over 5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Carers Cohort (optional): 1. Nominated carers of eligible patients will be eligible to participate. 2. Aged 18 years or over 3. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria

1. Participants cannot be actively undertaking a centre-based pulmonary rehabilitation program. However past completion of such a program is permitted.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 14, 2026