Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial) (SHIELD)
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ClinicalTrials.gov Identifier: NCT04034212 |
Recruitment Status :
Completed
First Posted : July 26, 2019
Last Update Posted : March 31, 2022
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Condition or disease | Intervention/treatment | Phase |
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COPD | Other: Singing for Lung Health group attendance | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
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 |
Official Title: | Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial) |
Actual Study Start Date : | October 1, 2019 |
Actual Primary Completion Date : | February 15, 2022 |
Actual Study Completion Date : | February 15, 2022 |

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

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034212
United Kingdom | |
National Heart and Lung Institute, Imperial College London | |
London, United Kingdom |
Study Chair: | Nicholas Hopkinson | Imperial College London |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT04034212 |
Other Study ID Numbers: |
IRAS Project ID: 259170 19IC5000 ( Other Identifier: Imperial College London ) |
First Posted: | July 26, 2019 Key Record Dates |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COPD |
Lung Diseases Respiratory Tract Diseases |