A Novel Home-based Physical Activity Intervention for Stable Chronic Heart Failure Patients (PAHF)
Primary Purpose
Heart Failure, Systolic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure, Systolic
Eligibility Criteria
Inclusion Criteria:
- Adults (>50 years of age) with chronic HF due to reduced ejection fraction
- Clinically stable for at least 6 weeks prior to screening
- Receipt of optimal medical treatment
- Able to walk and perform activities of daily living independently
- New York Heart Association functional class II-IV
- Left ventricular ejection fraction <40%
- Willingness to undertake a physical activity intervention
- Willingness to visit the clinical research facility on 2 separate occasions
Exclusion Criteria:
- Severe aortic stenosis
- Severe cardiac arrhythmias
- Myocardial infarction, percutaneous coronary intervention and/or bypass graft surgery over the past 3 months
- Severely obese i.e. body mass index >40
- Implanted with left ventricular assist device
- Current participation in cardiac rehabilitation programme
- Inability to provide informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Physical Activity
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with heart failure screened, recruited into and completing the intervention
Data will be collected on recruitment and retention rates and adherence to intervention and trial procedures. Collated data will be expressed in percentages.
Secondary Outcome Measures
Quality of Life Score using Minnesota living with heart failure questionnaire
This is a qualitative marker which will be assessed using the Minnesota Living with Heart Failure Questionnaire. Pre and post intervention scores will be analysed to assess differences in this outcome.
Maximum Oxygen Consumption (ml/Kg/min) Post intervention
This is a marker of overall fitness levels and the investigators shall sample data pre and post intervention to assess changes in fitness during the intervention
Haemodynamic markers (cardiac output, stroke Volume)
Cardiac output (L/min) is the amount of blood pumped out of the ventricles per minute while stroke volume (ml/beat) is the amount of blood pumped out of the heart per beat. Both markers gives an indication of cardiac function and higher values during exercise indicates better functioning of the heart. The investigators shall evaluate these markers pre and post intervention
Full Information
NCT ID
NCT03677271
First Posted
September 5, 2018
Last Updated
September 17, 2018
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT03677271
Brief Title
A Novel Home-based Physical Activity Intervention for Stable Chronic Heart Failure Patients
Acronym
PAHF
Official Title
Personalised Home-based Physical Activity Intervention in Older Adults With Heart Failure: Advancing Towards an Effective Clinical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 16, 2015 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Primary Outcome Measure Information:
Title
Number of participants with heart failure screened, recruited into and completing the intervention
Description
Data will be collected on recruitment and retention rates and adherence to intervention and trial procedures. Collated data will be expressed in percentages.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of Life Score using Minnesota living with heart failure questionnaire
Description
This is a qualitative marker which will be assessed using the Minnesota Living with Heart Failure Questionnaire. Pre and post intervention scores will be analysed to assess differences in this outcome.
Time Frame
2 years
Title
Maximum Oxygen Consumption (ml/Kg/min) Post intervention
Description
This is a marker of overall fitness levels and the investigators shall sample data pre and post intervention to assess changes in fitness during the intervention
Time Frame
2 years
Title
Haemodynamic markers (cardiac output, stroke Volume)
Description
Cardiac output (L/min) is the amount of blood pumped out of the ventricles per minute while stroke volume (ml/beat) is the amount of blood pumped out of the heart per beat. Both markers gives an indication of cardiac function and higher values during exercise indicates better functioning of the heart. The investigators shall evaluate these markers pre and post intervention
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (>50 years of age) with chronic HF due to reduced ejection fraction
Clinically stable for at least 6 weeks prior to screening
Receipt of optimal medical treatment
Able to walk and perform activities of daily living independently
New York Heart Association functional class II-IV
Left ventricular ejection fraction <40%
Willingness to undertake a physical activity intervention
Willingness to visit the clinical research facility on 2 separate occasions
Exclusion Criteria:
Severe aortic stenosis
Severe cardiac arrhythmias
Myocardial infarction, percutaneous coronary intervention and/or bypass graft surgery over the past 3 months
Severely obese i.e. body mass index >40
Implanted with left ventricular assist device
Current participation in cardiac rehabilitation programme
Inability to provide informed consent.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32958484
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.
Results Reference
derived
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A Novel Home-based Physical Activity Intervention for Stable Chronic Heart Failure Patients
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