Clinical trial NCT03677271: A Novel Home-based Physical Activity Intervention for Stable Chronic Heart Failure Patients
Official title: Personalised Home-based Physical Activity Intervention in Older Adults With Heart Failure: Advancing Towards an Effective Clinical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2018-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The project focuses on heart failure (HF), a complex clinical syndrome of symptoms and signs that suggest the efficiency of the heart as a pump is impaired. Around 950,000 people in the UK have HF. Both the incidence and prevalence of heart failure increase steeply as a result of an ageing population, improved survival of people with ischaemic heart disease and more effective treatments for heart failure. Aside from the obvious individual burden HF also accounts for 1 million inpatient bed days - 2% of all NHS inpatient bed days and 5% of all emergency medical admissions to hospital which are projected to rise by 50% over the next 25 years. There is a pressing need to explore effective ways to manage the individual and societal burden of HF.

Despite exercise being an effective, safe, and a recommended (class I) therapy for people with heart failure according to clinical guidelines from the UK, EU, and USA, it is currently out of reach for majority people with HF. This project addresses this directly by designing and evaluating an exercise therapy that will be available to those living with HF with potential to improve their symptoms, function and quality of life

Detailed description: The present project aligns with Ageing Body Theme of the Newcastle NIHR Biomedical Research Centre. In particular the Chronic Cardiac Disease theme because it focuses on Heart Failure and how to improve clinical care and outcomes, physical function and quality of life of those living with heart failure. The project will develop and evaluate a novel non-pharmacological therapeutic approach (home-based exercise programme with behavioural support) which recognises the complexity of heart failure and the need to treat each individual patient in an optimal way. Such therapy will be tailored for people with heart failure who are, under current clinical care, lacking the well-recognised benefits associated with exercise therapy. After initial evaluation, it is expected that this project will inform development of a large definitive trial (subject to separate funding application) which findings will be translated into clinical care to improve outcomes in people with heart failure. Results of such a trial are expected to have a significant impact on current clinical practice and the development of new cardiac rehabilitation guidelines for heart failure.

It is important to indicate that home-based exercise cardiac rehabilitation programmes have been introduced in an attempt to widen access and participation as an alternative to supervised centre-based rehabilitation in conditions other than heart failure. Home-based exercise programmes are reported to be equally effective as centre based programmes in people with coronary artery disease i.e. following myocardial infarction and/or revascularisation, but remain to be designed and evaluated in those living with heart failure and this is subject to the present investigation

Eligibility criteria: Inclusion Criteria:

1. Adults (\>50 years of age) with chronic HF due to reduced ejection fraction
2. Clinically stable for at least 6 weeks prior to screening
3. Receipt of optimal medical treatment
4. Able to walk and perform activities of daily living independently
5. New York Heart Association functional class II-IV
6. Left ventricular ejection fraction \<40%
7. Willingness to undertake a physical activity intervention
8. Willingness to visit the clinical research facility on 2 separate occasions

Exclusion Criteria:

1. Severe aortic stenosis
2. Severe cardiac arrhythmias
3. Myocardial infarction, percutaneous coronary intervention and/or bypass graft surgery over the past 3 months
4. Severely obese i.e. body mass index \>40
5. Implanted with left ventricular assist device
6. Current participation in cardiac rehabilitation programme
7. Inability to provide informed consent.

Primary outcomes:
measure: Number of participants with heart failure screened, recruited into and completing the intervention
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life Score using Minnesota living with heart failure questionnaire
timeFrame: 2 years
measure: Maximum Oxygen Consumption (ml/Kg/min) Post intervention
timeFrame: 2 years
measure: Haemodynamic markers (cardiac output, stroke Volume)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Okwose NC, O'Brien N, Charman S, Cassidy S, Brodie D, Bailey K, MacGowan GA, Jakovljevic DG, Avery L. Overcoming barriers to engagement and adherence to a home-based physical activity intervention for patients with heart failure: a qualitative focus group study. BMJ Open. 2020 Sep 21;10(9):e036382. doi: 10.1136/bmjopen-2019-036382.