Condition category
Circulatory System
Date applied
29/05/2007
Date assigned
03/07/2007
Last edited
28/03/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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

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

  1. 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

Editorial Notes