NCT04266951

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a pervasive, insidious condition associated with catastrophic socioeconomic, healthcare and personal implications. This proposal outlines how a group singing intervention, led by clinical personnel and a community singing leader, can address these challenges. Built upon existing ties between the Principal Investigator (PI) and local COPD support group, this project is co-designed by patients and clinicians. Modelled on similar interventions internationally, this project is pioneering in Ireland. Outputs will include a participant-led symposium and three community COPD choirs, in addition to a number of academic publications. This project is funded by the Irish Research Council (IRC) "New Foundations" scheme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

June 14, 2019

Last Update Submit

January 28, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Patient anxiety and depression

    Hospital Anxiety and Depression Scale (HADS). This questionnaire is widely used to measure anxiety and depression in a general medical population of patients. The questionnaire features seven questions for anxiety and seven for depression of which can be answered within 2 - 5 minutes. Each item is scored from 0-3 with a higher score indicating a greater presence of either anxiety or depression. Maximal (worst) score for either factor is 21.

    8 weeks

  • Functional capacity

    Six minute walk test (6MWT). The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. This is measured in metres with levels of oxygen saturation and heart rate pre and post the test also recorded.

    8 weeks

  • Disease impact

    COPD Assessment test (CAT). The CAT is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. This is a patient-completed questionnaire assessing all aspects of the impact of COPD (cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels) There are 8 questions on a 1 to 5 point scale. A higher score indicates more disease impact. Max score is 40.

    8 weeks

Secondary Outcomes (2)

  • Lung function

    8 weeks

  • Qualitative evaluation of intervention

    8 weeks

Study Arms (1)

Group singing and breathing control training

OTHER
Behavioral: Singstrong:

Interventions

Singstrong:BEHAVIORAL

Group singing and breathing control training

Group singing and breathing control training

Eligibility Criteria

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

You may qualify if:

  • Participants must have an existing diagnosis of COPD according to recognised diagnostic criteria, must be clinically stable, and not have suffered an exacerbation in the 2 weeks prior to testing.
  • All participants must be at least 18 years of age. There is no upper age limit.
  • Participants may be male or female.
  • They must have a good command of written and spoken English.

You may not qualify if:

  • Lack of a clinical diagnosis of COPD
  • Presence of physical of psychological co-morbidities precluding participation in either testing or intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Limerick

Limerick, Ireland

Location

MeSH Terms

Conditions

Respiration DisordersPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roisin Cahalan, PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pilot study: Pre and post intervention with a single patient cohort.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2019

First Posted

February 12, 2020

Study Start

April 1, 2019

Primary Completion

March 31, 2020

Study Completion

April 30, 2020

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations