Plain English Summary
Background and study aims
Exercise training seems to offer benefits to younger people with heart failure, but many exercise programmes are not suitable for older people to take part in. An exercise programme has been developed specifically for older people with heart failure, and the aim of this study is to test whether the exercise programme improves physical function, symptoms and quality of life in older people with heart failure.
Who can participate?
Patients aged 70 or older with chronic heart failure
What does the study involve?
Participants are randomly allocated to one of two groups: either to an exercise training group or to a group who receives usual care i.e. no exercise. Participants come to the research clinic on three occasions: at the start of the study, again after 8 weeks, and after 24 weeks. At each visit, participants complete questionnaires about their symptoms, quality of life, how active they are, and about their mood. They undergo walking and leg strength tests and are asked to wear a small box clipped to their belt during the day for seven days to record how much walking and other activity they do. Participants in the usual care group receive the same care and treatment as they have at the moment. Participants in the exercise training group come twice a week for 8 weeks to small group exercise sessions at the hospital. Taxi transport is provided to bring them back and forward for each session. Each session is led by an experienced physiotherapist, who takes care that each person exercises to their own individual ability. The sessions last up to 1 hour. Most of the exercises are done sitting in a chair, and some involve using elastic bands to help the arm and leg muscles to work harder. The therapist also guides brief talks about exercise, its benefits, how to get started and how to deal with setbacks. A leaflet with this information is provided. After 8 weeks, participants have learned the exercises and continue with the exercises at home for 16 weeks more. During this time, the physiotherapist stays in touch by phone to encourage participants and to help them overcome any problems. Participants also record their exercises and activities in a diary.
What are the possible benefits and risks of participating?
The exercise programme may improve participants’ symptoms, give them more energy, and allow them to do more. This is not guaranteed, which is this study is needed. The programme of exercise training has been shown to be safe, and the exercise is supervised by an experienced therapist for the first 8 weeks. Sudden, vigorous exercise can be hazardous for people of any age, but it is not part of this study. Participants may feel a bit more tired than usual immediately after the exercise session, or even the next day.
Where is the study run from?
University of Dundee (UK)
When is the study starting and how long is it expected to run for?
August 2007 to August 2010
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Marion McMurdo
m.e.t.mcmurdo@dundee.ac.uk
Trial website
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
A randomised controlled trial of the effect of exercise training on exercise capacity in older patients with heart failure
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
Tayside Committee on Medical Ethics A, 09/02/2007, ref: 07/S1404/1
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a 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
Behavioural
Phase
Drug names
Primary outcome measure
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 (if study stopped)
Eligibility
Participant inclusion criteria
Patients will be recruited from day hospital, heart failure and cardiology clinics
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
University of Dundee
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
IPD sharing statement
The protocol is available from the authors on request but is not available online. Study data are available for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained. Contact for data sharing: Dr Catrina Forde (c.forde@dundee.ac.uk)
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN51615566_BasicResults_18May18.pdf
Publication list
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.
Additional files
- ISRCTN51615566_BasicResults_18May18.pdf Uploaded 18/05/2018