Contact information
Type
Scientific
Primary contact
Prof Marion McMurdo
ORCID ID
Contact details
Section of Ageing and Health
Division of Medicine and Therapeutics
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632436
m.e.t.mcmurdo@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
METM HF/ex
Study information
Scientific title
Acronym
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?
Ethics approval
Approved by Tayside Committee on Medical Ethisc A (ref: 07/S1404/1)
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Chronic heart failure
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change in 6 minute walking distance, recorded at baseline, 8 and 24 weeks.
Secondary outcome measures
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
Overall trial start date
06/08/2007
Overall trial end date
05/08/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
112
Participant 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
Recruitment start date
06/08/2007
Recruitment end date
05/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Ageing and Health
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344436
research@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (ref: CZH/4/426) (UK)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22271753
Publication citations
-
Results
Witham MD, Fulton RL, Greig CA, Johnston DW, Lang CC, van der Pol M, Boyers D, Struthers AD, McMurdo ME, Efficacy and cost of an exercise program for functionally impaired older patients with heart failure: a randomized controlled trial., Circ Heart Fail, 2012, 5, 2, 209-216, doi: 10.1161/CIRCHEARTFAILURE.111.963132.