A randomised controlled trial of exercise rehabilitation in addition to specialist heart failure nurse intervention
| ISRCTN | ISRCTN68886157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68886157 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Public Health & Epidemiology
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| C.B.Jolly@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/11/2004 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Public Health & Epidemiology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
c/o Dr Clare Croft-White
Research & Development Division
Department of Health
Skipton House
80 London Road
London
SE1 6LH
United Kingdom
"ROR" |
https://ror.org/03sbpja79 |
|---|
Funders
Funder type
Government
Department of Health (DH/BHF Heart Failure research Initiative) (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/03/2007 | Yes | No | |
| Results article | results | 01/02/2009 | Yes | No |
Editorial Notes
05/07/2018: Publication reference added
