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Open Access Highly Accessed Study protocol

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

Kate Jolly1*, Rod S Tayor2, Gregory YH Lip3, Sheila M Greenfield4, Michael K Davies5, Russell C Davis6, Jonathan W Mant4, Sally J Singh7, Jackie T Ingram4, Jane Stubley6 and Andrew J Stevens1

Author Affiliations

1 Department of Public Health & Epidemiology, Public Health Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

2 Peninsula Medical School, University of Exeter, EX2 5DW, UK

3 University Department of Medicine, City Hospital, Dudley Road, Birmingham, B18 7QH, UK

4 Department of Primary Care & General Practice, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

5 Department of Cardiology, University Hospital Birminghan NHS Trust, Birmingham, B15 2TH, UK

6 Sandwell and West Birmingham NHS Trust, Lyndon, West Bromwich, West Midlands, B71 4HJ, UK

7 Dept Cardiac and Pulmonary Rehabilitation, University Hospitals of Leicester, UK

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BMC Cardiovascular Disorders 2007, 7:9  doi:10.1186/1471-2261-7-9

Published: 7 March 2007

Abstract

Background

Exercise has been shown to be beneficial for selected patients with heart failure, but questions remain over its effectiveness, cost-effectiveness and uptake in a real world setting. This paper describes the design, rationale and recruitment for a randomised controlled trial that will explore the effectiveness and uptake of a predominantly home-based exercise rehabilitation programme, as well as its cost-effectiveness and patient acceptability.

Methods/design

Randomised controlled trial comparing specialist heart failure nurse care plus a nurse-led predominantly home-based exercise intervention against specialist heart failure nurse care alone in a multiethnic city population, served by two NHS Trusts and one primary care setting, in the United Kingdom.

169 English speaking patients with stable heart failure, defined as systolic impairment (ejection fraction ≤ 40%). with one or more hospital admissions with clinical heart failure or New York Heart Association (NYHA) II/III within previous 24-months were recruited.

Main outcome measures at 1 year: Minnesota Living with Heart Failure Questionnaire, incremental shuttle walk test, death or admission with heart failure or myocardial infarction, health care utilisation and costs. Interviews with purposive samples of patients to gain qualitative information about acceptability and adherence to exercise, views about their treatment, self-management of their heart failure and reasons why some patients declined to participate.

The records of 1639 patients managed by specialist heart failure services were screened, of which 997 (61%) were ineligible, due to ejection fraction>40%, current NYHA IV, no admission or NYHA II or more within the previous 2 years, or serious co-morbidities preventing physical activity. 642 patients were contacted: 289 (45%) declined to participate, 183 (39%) had an exclusion criterion and 169 (26%) agreed to randomisation.

Discussion

Due to safety considerations for home-exercise less than half of patients treated by specialist heart failure services were eligible for the study. Many patients had co-morbidities preventing exercise and others had concerns about undertaking an exercise programme.