Condition category
Circulatory System
Date applied
08/04/2004
Date assigned
10/06/2004
Last edited
23/03/2007
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 Kate Jolly

ORCID ID

Contact details

Department of Public Health & Epidemiology
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
C.B.Jolly@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BRUM-CHF

Study hypothesis

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

Approval was obtained from Sandwell and West Birmingham Local Research Ethics Committee (ref: 03/10/708).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is the Minnesota Living with Heart Failure Questionnaire (MLwHF) Questionnaire.

Secondary outcome measures

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.

Overall trial start date

01/11/2004

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant 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%

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

169

Participant exclusion criteria

No exclusion criteria provided

Recruitment start date

01/11/2004

Recruitment end date

01/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

c/o Dr Clare Croft-White
Research & Development Division
Department of Health
Skipton House
80 London Road
London
SE1 6LH
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Department of Health (DH/BHF Heart Failure research Initiative) (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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17343738

Publication citations

  1. Jolly K, Tayor RS, Lip GY, Greenfield SM, Davies MK, Davis RC, Mant JW, Singh SJ, Ingram JT, Stubley J, Stevens AJ, Home-based exercise rehabilitation in addition to specialist heart failure nurse care: design, rationale and recruitment to the Birmingham Rehabilitation Uptake Maximisation study for patients with congestive heart failure (BRUM-CHF): a randomised controlled trial., BMC Cardiovasc Disord, 2007, 7, 9, doi: 10.1186/1471-2261-7-9.

Additional files

Editorial Notes