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ISRCTN
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ISRCTN51615566
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of the effect of exercise training on exercise capacity in older patients with heart failure
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Scientific title
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Acronym
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N/A
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Serial number at source
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METM HF/ex
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Study hypothesis
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Exercise training is known to benefit younger patients with heart failure. However most heart failure patients are older. We aim to recruit heart failure patients aged 70 years or older to either 24 weeks of exercise training or usual care. The exercise training program was developed in a pilot study. The study question: Is the newly developed exercise program effective in improving exercise capacity in older people with chronic heart failure?
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Ethics approval
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Approved by Tayside Committee on Medical Ethisc A (ref: 07/S1404/1)
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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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Disease/condition/study domain
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Chronic heart failure
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Participants - inclusion criteria
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Patients will be recruited from day hospital, heart failure and cardiology clinics.
Inclusions criteria:
1. Patients aged 70 years or older
2. Diagnosis of chronic heart failure according to the European Society of Cardiology guidelines
3. Evidence of Left Ventricular (LV) systolic dysfunction
4. In the New York Heart Association class II or III
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Participants - exclusion criteria
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1. Aortic stenosis with peak gradient >30 mmHg
2. Sustained Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) outside of the context of an acute myocardial infarction
3. Unstable angina
4. Unable to walk without human assistance
5. Atrial fibrilation with a ventricular rate of >100/min
6. Currently enrolled in another trial
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Anticipated start date
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06/08/2007
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Anticipated end date
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05/08/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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112
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Interventions
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Intervention group: Eight weeks of twice per week therapist-led supervised small group intermittent functional aerobic exercise and strength training, with the duration of sessions gradually increased to 60 minutes. This will be followed by a 16-week home-based exercise phase, which will include self-monitoring and telephone instruction and encouragement from the therapist.
The control group will receive usual care.
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Primary outcome measure(s)
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Change in 6 minute walking distance, recorded at baseline, 8 and 24 weeks.
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Secondary outcome measure(s)
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The following will be recorded at baseline, 8 and 24 weeks:
1. Change in quadriceps muscle strength
2. Repetitive strength
3. Incremental shuttle walk test
4. Quality of life
5. Carer strain
6. Mood and self reported function
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Sources of funding
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Chief Scientist Office (ref: CZH/4/426) (UK)
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Trial website
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Publications
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Contact name
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Prof
Marion
McMurdo
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Address
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Section of Ageing and Health
Division of Medicine and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Tel
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+44 (0)1382 632436
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Fax
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+44 (0)1382 660675
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Email
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m.e.t.mcmurdo@dundee.ac.uk
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Sponsor
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University of Dundee (UK)
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Address
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Research and Innovation Services
11 Perth Road
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City/town
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Dundee
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Zip/Postcode
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DD1 4HN
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Country
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United Kingdom
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Tel
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+44 (0)1382 344436
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Fax
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+44 (0)1382 345423
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Email
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research@dundee.ac.uk
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Date applied
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29/05/2007
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Last edited
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21/09/2007
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Date ISRCTN assigned
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03/07/2007
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