Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial) (SHIELD)

• ClinicalTrials.gov Identifier: NCT04034212
• Recruitment Status: Completed
• First Posted: July 26, 2019
• Last Update Posted: March 31, 2022
• Sponsor: Imperial College London
• Information provided by (Responsible Party): Imperial College London

Tracking Information

• First Submitted Date: July 22, 2019
• First Posted Date: July 26, 2019
• Last Update Posted Date: March 31, 2022
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: February 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2019)

Change from Baseline in Short Form 36 tool (SF-36) [ Time Frame: At baseline, then repeated after 12 weeks. ]

A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 24, 2019)

• Changes in COPD assessment test (CAT) [ Time Frame: At baseline, then repeated after 12 weeks. ]
  a disease specific health status measure. This includes 8 items, scored 0-5 with a possible score from 0 (best) to 40 (worst).
• Changes in Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: At baseline, then repeated after 12 weeks. ]
  Self-administered questionnaire to assess for symptoms, and severity, of anxiety. Includes seven questions scored from 0 to 3, giving a total score out of 21. Lower scores indicate less symptoms of anxiety.
• Changes in Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: At baseline, then repeated after 12 weeks. ]
  Self-administered questionnaire to assess for symptoms, and severity, of depression. Includes nine questions scored from 0 to 3, giving a total score out of 27. Lower scores indicate less symptoms of depression.
• Changes in Dyspnoea-12 questionnaire [ Time Frame: At baseline, then repeated after 12 weeks. ]
  Assessment of dyspnoea. Includes 12 descriptors scored from 0 to 3, giving a total score of 36. Lower scores indicate less severe dyspnoea.
• Changes in Six-minute walk test [ Time Frame: At baseline, then repeated after 12 weeks. ]
  Distance walked in 6 minutes. Tests exercise capacity. To be performed in accordance with ATS/ERS guidelines including a practice walk.
• Changes in PROactive physical activity in COPD tool (cPPAC) [ Time Frame: At baseline, then repeated after 12 weeks. ]
  This involves a one week recall questionnaire and McRoberts MoveMonitor device physical activity monitor.
• Changes in Activities-specific Balance Confidence scale [ Time Frame: At baseline, then repeated after 12 weeks. ]
  Balance confidence during activities of daily living, assessed using self-reported questionnaire. 16 item scale which gives a total balance confidence score of 0 to 100. Lower scores indicate less confidence.
• Changes in Short Physical Performance Battery (SPPB) [ Time Frame: At baseline, then repeated after 12 weeks. ]
  Physical performance evaluated using the SPPB (instrumented with the McRoberts fixed-body sensor MoveTest device). Consists of 4 performance tasks (balance, walk speed and sit-to-stand) scored from 0 to 4, giving a total score out of 12 for SPPB.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial)
• Official Title: Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial)
• Brief 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

Masking of participants not possible due to the nature of the intervention.

Primary Purpose: Treatment

• Condition: COPD

Intervention

Other: Singing for Lung Health group attendance

Singing for Lung Health is a group singing intervention designed for people with chronic lung diseases. Participants would attend weekly sessions lasting 1 hour.

Study Arms

• Experimental: Singing for Lung Health group
  Once weekly attendance at a Singing for Lung Health group for 12 weeks.
  Intervention: Other: Singing for Lung Health group attendance
• No Intervention: Usual Care group
  Usual care group, participants given advice on physical activity while continuing with usual care.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 24, 2019): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 15, 2022
• Actual Primary Completion Date: February 15, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adults with stable COPD

Exclusion Criteria:

• Pulmonary rehabilitation less than 4 months ago
• Unable to take part in singing sessions due to comorbidity (e.g. life limiting illness, cognitive impairment)
• Previous participation in SLH classes

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04034212
• Other Study ID Numbers: IRAS Project ID: 259170; 19IC5000 ( Other Identifier: Imperial College London )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Imperial College London
• Study Sponsor: Imperial College London
• Collaborators: Not Provided

Investigators

• Study Chair: Nicholas Hopkinson; Imperial College London

• PRS Account: Imperial College London
• Verification Date: March 2022