Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial) (SHIELD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04034212|
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|COPD||Other: Singing for Lung Health group attendance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Masking of participants not possible due to the nature of the intervention.|
|Official Title:||Singing for Health: Improving Experiences of Lung Disease (SHIELD Trial)|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||April 2022|
Experimental: Singing for Lung Health group
Once weekly attendance at a Singing for Lung Health group for 12 weeks.
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.
- 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.
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
|Contact: Keir EJ Philip, MRCP||0044(0)2073528121 ext email@example.com|
|National Heart and Lung Institute, Imperial College London||Recruiting|
|London, United Kingdom|
|Contact: Keir EJ Philip, MRCP|
|Study Chair:||Nicholas Hopkinson||Imperial College London|