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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
Newcastle-upon-Tyne Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure, Systolic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    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
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    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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