Effect of singing lessons on physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

ISRCTN	ISRCTN39714922
DOI	https://doi.org/10.1186/ISRCTN39714922
Secondary identifying numbers	V3

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Nicholas Hopkinson
Scientific

Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom

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
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Effect of singing lessons on physical activity in patients with COPD: a prospective, single-blind, randomised controlled trial
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	01/05/2011

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Patients with COPD with MRC dyspnea score >3/5 2. Either sex, aged >21 years
Key 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
Date of first enrolment	01/12/2010
Date of final enrolment	01/05/2011

Royal Brompton Hospital

London
SW3 6NP
United Kingdom

Imperial College London (UK)
University/education

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

"ROR"	https://ror.org/041kmwe10

Government

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

No information available

Royal Brompton & Harefield NHS Foundation Trust (UK)

No information available

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/11/2012		Yes	No