Singing and COPD: a pilot randomised controlled trial

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: Randomisation will be conducted by a secure remote randomisation service independent of the research team. Randomisation will employ random permuted blocks of variable length with stratification by sex and COPD severity. Intervention: a structured and progressive programme of group singing for participants with COPD delivered over 10 weeks in sessions lasting 90 minutes, supplemented by home practice between sessions supported by printed and audio‐visual material. The participants in the control condition will receive treatment as usual (TAU). Participants will be assessed at baseline using a number of validated, short questionnaires to assess health status and psychological wellbeing. In addition, lung function will be assessed using standardised spirometry and a new technique which assesses patterns of breathing. The focus of interest is on the extent to which patients engage in shallow upper chest breathing, or engage their diaphragm is deeper abdominal breathing. Following baseline assessment, half of the participants will be selected at random to participate in a singing programme and half will receive usual care. The singing programme will be implemented over 10 90‐minute sessions. The programme will involve breathing exercises and songs which will encourage controlled breathing and progressive extension of the time taken to breathe out. Following the end of the singing programme, participants will be assessed for a second time. There will then be a follow up period of 3 months during which no singing activity will take place, and the participants will be assessed for a third time to see whether any changes observed immediately following the intervention are maintained. CONDITION: Chronic obstructive pulmonary disease (COPD) ; Respiratory ; Chronic obstructive pulmonary disease PRIMARY OUTCOME: Quality of life assessed with the COPD Assessment Test (CAT) at baseline, three months following the ten‐week intervention, and then after a further three months. SECONDARY OUTCOME: ; Measured at baseline, three months following the ten‐week intervention, and then after a further three months:; 1. Breathlessness assessed using mMRC self‐completion questionnaire; 2. Physical health related quality of life and mental health related quality of life assessed using SF‐36 v2 self‐completion questionnaire; 3. Generalised anxiety disorder assessed by GAD‐7 (self‐completion questionnaire); 4. Depression assessed by PHQ‐9 (self‐completion questionnaire); 5. Lung function and patterns of breathing assessed by standardised spirometry and structured light plethysmography; 6. Functional exercise measured by the standardised six‐minute walk test; INCLUSION CRITERIA: The trial will be open to patients: 1. With a diagnosis of COPD who have received pulmonary rehabilitation (or in receipt during the recruitment period) 2. Willing to undergo the collection of assessments planned 3. Willing to be randomised to either the intervention or control group 4. Able to attend one of the two groups planned (given the proposed day and time)
Epistemonikos ID: 6b065eb4975cb3a038e500678d07525cb02e31cc
First added on: Aug 24, 2024