A phase 2 clinical trial examining the feasibility of SingINg For breathing in chronic obstructive pulmonary disease (COPD) aNd interstitial lung disease (ILD) pAtients

Not Applicable

Recruiting

• Conditions: chronic obstructive pulmonary disease; interstitial lung disease; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621001274864
• Lead Sponsor: St Vincents Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-20
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patient Cohort:
1.Participants with a confirmed diagnosis of COPD or ILD
•Diagnosis confirmed on either CT chest scan (within the last 5 years) or lung function testing (within the last 2 years)
2.On stable treatment for at least 4 weeks
•Has not started any new or changed existing cardiorespiratory medications (including antibiotics and oral steroids). To be determined by study site clinician.
•Has not been admitted to hospital with an exacerbations of their underlying disease (COPD or ILD) within the past 4 weeks.
3.Modified Medical Research Council dyspnoea score grerater than or equal to 2
4.Aged 18 years or over
5.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Carers Cohort (optional):
1.Nominated carers of eligible patients will be eligible to participate.
2.Aged 18 years or over
3.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

1.Participants cannot be actively undertaking a centre-based pulmonary rehabilitation program. However past completion of such a program is permitted.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 2 (feasibility outcome) - Outcome is composite of number of participants enrolled, randomised and completed at 6 months. Completion is defined as intervention arm attending 8 of 12 session over 12 weeks and control arm completing 12 week assessment. Outcome will be assessed by audit of enrolment, randomisation, and attendance logs.[6 months post study commencement]