Condition category
Respiratory
Date applied
22/11/2010
Date assigned
25/11/2010
Last edited
11/12/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Hopkinson

ORCID ID

Contact details

Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V3

Study information

Scientific title

Effect of singing lessons on physical activity in patients with COPD: a prospective, single-blind, randomised controlled trial

Acronym

Study hypothesis

That 8 weeks of twice weekly vocal coaching will improve daily physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to a control group taking part in a film club.

Ethics approval

The Brompton, Harefield & NHLI Research Ethics Committee, 15/12/2009, ref: 07/H0708/900

Study design

Single-blind prospective randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

Patients will be randomised to receive either:
1. Singing lessons twice per week for 8 weeks
2. Film club once per week for 8 weeks

Participants will be followed for 1 week after the end of the program.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Daily physical activity assessed using the SenseWear armband at one week after the end of the program

Secondary outcome measures

1. Hospital Anxiety Depression (HAD) score
2. COPD Assessment Test (CAT) score
3. Shuttle walk distance
All outcomes will be assessed 1 week after the end of the program

Overall trial start date

01/12/2010

Overall trial end date

01/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with COPD with MRC dyspnea score >3/5
2. Either sex, aged >21 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Patients with a life expectancy of <3 months
2. Patients where a diagnosis of primary hyperventilation has been made i.e. with normal lung function test results
3. Other co-morbidities will be permitted unless they are likely to interfere directly with participation in the study

Recruitment start date

01/12/2010

Recruitment end date

01/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

c/o Gary Roper
G02 SAF Building
S Ken Campus
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) Respiratory Biomedical Research Unit (BRU) (UK) - run jointly by:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Brompton & Harefield NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Imperial College London, National Heart & Lung Institute (NHLI) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23145504

Publication citations

Additional files

Editorial Notes