NCT04034212

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2.4 years

First QC Date

July 22, 2019

Last Update Submit

March 29, 2022

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Short Form 36 tool (SF-36)

    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.

    At baseline, then repeated after 12 weeks.

Secondary Outcomes (8)

  • Changes in COPD assessment test (CAT)

    At baseline, then repeated after 12 weeks.

  • Changes in Generalised Anxiety Disorder Assessment (GAD-7)

    At baseline, then repeated after 12 weeks.

  • Changes in Patient Health Questionnaire 9 (PHQ-9)

    At baseline, then repeated after 12 weeks.

  • Changes in Dyspnoea-12 questionnaire

    At baseline, then repeated after 12 weeks.

  • Changes in Six-minute walk test

    At baseline, then repeated after 12 weeks.

  • +3 more secondary outcomes

Study Arms (2)

Singing for Lung Health group

EXPERIMENTAL

Once weekly attendance at a Singing for Lung Health group for 12 weeks.

Other: Singing for Lung Health group attendance

Usual Care group

NO INTERVENTION

Usual care group, participants given advice on physical activity while continuing with usual care.

Interventions

Singing for Lung Health group attendanceOTHER

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

Singing for Lung Health group

Eligibility Criteria

Age18 Years - 99 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with stable COPD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute, Imperial College London

London, United Kingdom

Location

Related Publications (1)

  • Philip KEJ, Buttery SC, Bowen S, Lewis A, Jeffery E, Alghamdi SM, Williams P, Alasmari AM, Alsulayyim AS, Orton CM, Conway F, Chan L, Vijayakumar B, Tana A, Tonkin J, Perkins A, Garner JL, Srikanthan K, Sadaka A, Pavitt MJ, Banya W, Lound A, Elkin S, Polkey MI, Man WD, Lewis K, Cave P, Fancourt D, Hopkinson NS. Singing for lung health in COPD: a multicentre randomised controlled trial of online delivery. BMJ Open Respir Res. 2024 May 2;11(1):e002365. doi: 10.1136/bmjresp-2024-002365.

    PMID: 38697677DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Singing

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhonationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Nicholas Hopkinson

    Imperial College London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking of participants not possible due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 26, 2019

Study Start

October 1, 2019

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)