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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN68886157 |
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Date of registration:
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10/06/2004 |
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Primary sponsor: |
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Public title:
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A randomised controlled trial of exercise rehabilitation in addition to specialist heart failure nurse intervention
BRUM-CHF |
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Scientific title:
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Date of first enrolment:
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Nov 1 2004 |
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Target sample size:
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169 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN68886157 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Kate
Jolly |
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Address:
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Department of Public Health & Epidemiology
Public Health Building
University of Birmingham
Edgbaston
B15 2TT
Birmingham
United Kingdom |
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Telephone:
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Email:
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C.B.Jolly@bham.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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%
Exclusion criteria: No exclusion criteria provided
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Heart failure
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Intervention(s)
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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.
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Primary Outcome(s)
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The primary outcome measure is the Minnesota Living with Heart Failure Questionnaire (MLwHF) Questionnaire.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Department of Health (DH/BHF Heart Failure research Initiative) (UK)
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