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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
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
COPD Other: Singing for Lung Health group attendance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Keir EJ Philip, MRCP 0044(0)2073528121 ext 8029 k.philip@imperial.ac.uk

Locations
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United Kingdom
National Heart and Lung Institute, Imperial College London Recruiting
London, United Kingdom
Contact: Keir EJ Philip, MRCP         
Sponsors and Collaborators
Imperial College London
Investigators
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Study Chair: Nicholas Hopkinson Imperial College London
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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: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases