The SINFONIA Study: A Randomised Controlled Trial to Determine Feasibility and Effectiveness of Online Group Singing for People With COPD or ILD and Breathlessness

BACKGROUND AND OBJECTIVE: People with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) experience chronic breathlessness and reduced quality of life (QOL). Specialised singing programs for people with lung disease may improve QOL and symptoms. METHODS: A randomised controlled trial conducted in Australia to determine the feasibility and effectiveness of 12 weeks of online, guided group singing on QOL (primary outcome, as measured by SF36), as compared to usual care in people with COPD or ILD. SECONDARY OUTCOMES: anxiety, depression, dyspnoea and loneliness. Intervention effectiveness was assessed using mixed effects linear regression. RESULTS: One hundred and one participants were randomised (50 singing, 51 control; 64 COPD, 37 ILD; mean age 69.6 years; 74% women; 42% mMRC = 2, 58% mMRC ≥ 3). The results of the primary endpoint were a mean treatment effect (MTE) of singing of 2.5 points (95% CI -1.9 to 6.8; p = 0.266) on SF-36 mental health score (MCS) and 2.6 points (95% CI -0.9 to 6.1; p = 0.138) on the physical component score (PCS), neither of which were statistically or clinically significant. In the per-protocol analysis, significant improvement in MCS was detected in participants who attended 8 or more sessions (MTE:4.8; 95% CI 0.1 to 9.5; p = 0.047). No significant effects on secondary outcomes were detected. No adverse events were reported. CONCLUSIONS: This RCT demonstrated that online group singing is a feasible intervention for people with COPD or ILD and breathlessness. Although the intention-to-treat analysis did not demonstrate effectiveness, per-protocol analyses suggest that singing may improve mental health components of QOL in people with COPD or ILD.