Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Primary outcome measure
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 study start date
01/12/2010
Overall study end date
01/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with COPD with MRC dyspnea score >3/5
2. Either sex, aged >21 years
Participant type(s)
Patient
Age group
Adult
Sex
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
England, United Kingdom
Study 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
England
United Kingdom
Sponsor type
University/education
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/11/2012 | Yes | No |