A randomised controlled trial of exercise rehabilitation in addition to specialist heart failure nurse intervention

ISRCTN	ISRCTN68886157
DOI	https://doi.org/10.1186/ISRCTN68886157
Protocol serial number	N/A
Sponsor	Department of Health (UK)
Funder	Department of Health (DH/BHF Heart Failure research Initiative) (UK)

Submission date: 08/04/2004
Registration date: 10/06/2004
Last edited: 05/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kate Jolly
Scientific

Department of Public Health & Epidemiology
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	C.B.Jolly@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of exercise rehabilitation in addition to specialist heart failure nurse intervention
Study acronym	BRUM-CHF
Study objectives	The primary research question seeks to evaluate whether there are additional benefits from exercise rehabilitation over specialist heart failure nurse management and to establish the cost-effectiveness and patient acceptability of a predominantly home-based programme of exercise rehabilitation. In addition, the study will investigate the patient experience of heart failure and rehabilitation whilst attaining information about effectiveness, uptake and compliance of patients in a predominantly home-based setting.
Ethics approval(s)	Approval was obtained from Sandwell and West Birmingham Local Research Ethics Committee (ref: 03/10/708).
Health condition(s) or problem(s) studied	Heart failure
Intervention	Intervention group: Six month structured exercise programme, predominantly home-based plus specialist heart failure nurse care. Usual care group: Specialist heart failure nurse care. Follow-up by postal questionnaire and clinical assessment occurs at 6 months and by postal questionnaire at 1 year.
Intervention type	Other
Primary outcome measure(s)	The primary outcome measure is the Minnesota Living with Heart Failure Questionnaire (MLwHF) Questionnaire.
Key secondary outcome measure(s)	Secondary outcome measures at six months are: 1. Composite of death or admission with heart failure or myocardial infarction 2. Admission with heart failure 3. Mortality (all-cause and vascular) 4. EuroQol questionnaire 5. Hamilton Anxiety and Depression Score (HADS) 6. Blood pressure 7. Self-reported physical activity 8. Distance walked on the Incremental Shuttle Walk Test (ISWT) At 12 months the ISWT and blood pressure measurements are omitted.
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	169
Key inclusion criteria	Patients referred to the specialist heart failure services, who have been admitted with heart failure or been New York Heart Association (NYHA) III within the previous year, with an ejection fraction of less than 40%
Key exclusion criteria	No exclusion criteria provided
Date of first enrolment	01/11/2004
Date of final enrolment	01/11/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Public Health & Epidemiology

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2009		Yes	No
Protocol article	protocol	07/03/2007		Yes	No

Editorial Notes

05/07/2018: Publication reference added