Heart Failure, SystolicPAHFNCT03677271
A Novel Home-based Physical Activity Intervention for Stable Chronic Heart Failure Patients
A study testing Physical Activity in people with Heart Failure, Systolic, run by Newcastle-upon-Tyne Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2015to 19 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Personalised Home-based Physical Activity Intervention in Older Adults With Heart Failure: Advancing Towards an Effective Clinical Therapy
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
Read the 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
- Conditions
- Heart Failure, Systolic
- Being tested
- Physical Activity
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Other | Not described Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start16 Dec 2015
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677271
- Sponsor's protocol ID
- 7512
- Other IDs
- IRAS project ID: 173307
- Acronym
- PAHF
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32958484
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Home-based Physical Activity Intervention in Older Adults With Heart Failure: Advancing Towards an Effective Clinical Therapy
- ClinicalTrials.gov ID
- NCT03677271
- Acronym / sponsor ID
- PAHF / 7512
- Conditions
- Heart Failure, Systolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Other | Behavioral: Physical Activity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity | Behavioural | Physical Activity |
Primary outcome
Number of participants with heart failure screened, recruited into and completing the intervention
Time frame: 2 years
Data will be collected on recruitment and retention rates and adherence to intervention and trial procedures. Collated data will be expressed in percentages.
3 secondary outcomes
Quality of Life Score using Minnesota living with heart failure questionnaire
Time frame: 2 years
Maximum Oxygen Consumption (ml/Kg/min) Post intervention
Time frame: 2 years
Haemodynamic markers (cardiac output, stroke Volume)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Derived from this study: PubMed 32958484Okwose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Heart Failure, Systolic, run by Newcastle-upon-Tyne Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with heart failure screened, recruited into and completing the intervention (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03677271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.