| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN51615566 |
| Date ISRCTN assigned | 03/07/2007 |
| Local reference number(s) | METM HF/ex |
| Public title | A randomised controlled trial of the effect of exercise training on exercise capacity in older patients with heart failure |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Chronic heart failure |
| Study hypothesis | 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? |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | Approved by Tayside Committee on Medical Ethisc A (ref: 07/S1404/1) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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 |
| Participants - exclusion criteria | 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 |
| Patient information material |
|
| Anticipated start date | 06/08/2007 |
| Anticipated end date | 05/08/2010 |
| Status of trial | Ongoing |
| Target number of participants | 112 |
| Interventions | 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. |
| Primary outcome measure(s) | Change in 6 minute walking distance, recorded at baseline, 8 and 24 weeks. |
| Secondary outcome measure(s) | 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 |
| Sources of funding | Chief Scientist Office (ref: CZH/4/426) (UK) |
| Sponsor name | University of Dundee (UK) |
| Sponsor details | Research and Innovation Services
11 Perth Road
Dundee
United Kingdom
DD1 4HN |
| Sponsor telephone | +44 (0)1382 344436 |
| Sponsor fax | +44 (0)1382 345423 |
| Sponsor email | research@dundee.ac.uk |
| Contact name | Prof Marion McMurdo |
| Contact details | Section of Ageing and Health
Division of Medicine and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
Dundee
United Kingdom
DD1 9SY |
| Contact telephone | +44 (0)1382 632436 |
| Contact fax | +44 (0)1382 660675 |
| Contact email | m.e.t.mcmurdo@dundee.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN51615566 |
| Date last extracted from ISRCTN register | 17/04/2008 |
