Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial)
Condition: COPD
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      A randomised clinical trial to assess the impact of group singing on health for people with
      chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      Singing for lung health (SLH) is a novel approach intended to improve the health status of
      people with respiratory disease. In group sessions, a trained singing leader teaches vocal
      techniques, which improve breathing control and posture, in the context of an enjoyable
      non-disease related activity. Initial pilot studies and qualitative work have established the
      concept that SLH can produce physical, psychological and social benefits. A properly
      conducted efficacy study is needed before larger scale trials, addressing impacts over a
      longer term and effect on health resource utilisation, can be undertaken.

      DESIGN: An assessor blind, parallel group, randomised controlled trial, to assess the effects
      of SLH compared to usual care on health status. The investigator will also evaluate the
      impact on physical activity, physical performance, and breathlessness perception to
      investigate the mechanisms involved.

      Research question and outcome measures:

      The primary outcome will be change in health status, assessed using the Short Form 36 tool
      (SF-36), comparing SLH and control arms.

      Additional endpoints will be: the COPD assessment test score (CAT), the MRC dyspnoea score,
      Dyspnoea-12, Activities-specific Balance Confidence scale (ABC scale).

      For psychological health, anxiety will be assessed using the GAD-7 and depression using the
      PHQ-9.

      Physical activity will be assessed using the cPPAC PROactive physical activity in COPD tool
      (a combination of questionnaire and actigraphy). Physical capacity using the six-minute walk
      test, and physical performance using the short physical performance battery.

      Assessments: At an initial baseline assessment a structured clinical history will take place
      and the diagnosis confirmed by spirometry. The outcomes outlined above will be recorded at
      baseline and then after 12 weeks.

      POPULATION: Adult patients with COPD will be recruited from primary and secondary care as
      well as through advertising. Diagnosis will be based on clinical history, confirmed by
      spirometry and a history of smoking. Participants in the active arm will attend once weekly
      SLH groups for 12 weeks. The comparison arm will receive usual care. Randomization will be
      stratified by prior participation in pulmonary rehabilitation and by MRC dyspnoea score, to
      ensure groups are matched.

      SAMPLE SIZE Sample size: Based on pilot data, where the standard deviation (SD) for change in
      SF-36 was 15 points, to identify a clinically relevant 10 point difference in SF-36 responses
      at a 0.05 level of significance with a 90% power would require 48 patients in each treatment
      arm. Allowing for 20% dropout the investigator will therefore recruit 120 patients.

      Primary analysis will be on an intention to treat basis. Change in parameters will be
      assessed comparing SLH/control using Generalised Linear Models to estimate treatment effects.
      In order to better understand changes in the SF-36 "anchor measure", the investigator will
      relate this to changes in measures of breathlessness, physical activity, capacity and
      performance.

      An additional responder analysis will compare the proportion in each treatment arm achieving
      a clinically important (10%) improvement in SF-36.

      Addendum: Due to the COVID-19 pandemic an it became inappropriate to continue delivering
      group singing sessions in person, so the first group of participants is to complete their 12
      weeks of intervention using online delivered sessions. This relates the first group of 18
      participants had been recruited, randomised, baseline assessments completed and begun the
      intervention. Their follow-assessments will be posted to participants for them to complete at
      home. All assessment measures will be the same as originally stated, however the 6MWT and
      SPPB require clinical supervision, so will not be completed. The results from this group will
      be reported separately to the rest of the study who will complete the original protocol when
      the situation with COVID-19 has improved, and it is safe for participants to do so. An
      appropriate amendment to ethical approval has been made. Data from the control group may also
      be reported separately, being of interest in itself, as a natural experiment regarding the
      impact of social distancing and shielding measures on people with COPD. Again, the variables
      assessed will not change.

      Addendum 2: Due to the ongoing COVID-19 pandemic, the study will continue to be conducted
      remotely, as described above, with online delivery of the singing intervention and remotely
      collected outcome measures. Most recent clinical spirometry will be used for COPD diagnosis
      confirmation. Due to no longer being able to conduct the object assessments of physical
      performance mean daily step count will also be reported as a secondary outcome measure. For
      clarification, the exclusion criteria of previous participation in Singing For Lung health,
      refers to no participation in the last year. Appropriate amendments to the ethical approval
      have been made.
    

Intervention name(s): Singing for Lung Health group attendance
Intervention type(s): Other
Intervention description(s): Singing for Lung Health is a group singing intervention designed for people with chronic lung diseases. Participants would attend weekly sessions lasting 1 hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD