Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF).

Study Overview
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Brief Summary
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The inability of the heart to pump out blood to the rest of the body organs is called heart failure (HF). HF affects almost 920,000 people in the UK, costing the NHS up to £2.33bn/year. Physical exercise programmes aiming to improve the heart's ability to pump out blood are used to a) reduce the risk of life-threatening events (e.g., heart attack), b) reduce admissions to hospital and c) improve individual's physical independence (e.g., walking unsupported, being able toperform daily essential activities). However, these physical exercise programmes have been cut short under the current COVID-19 pandemic, with support in most UK regions being restricted to online videos and advice. With many people with HF being asked to be shielded or self-isolate for an unknown duration, it is important to develop a reliable and cost-effective physical exercise service to support this clinical group. The research team has developed a novel physical exercise programme, fully-delivered online. Before assessing if it could improve clinical outcomes (e.g., heart's ability to pump out blood) and how cost-effective it could be, a 10-month pilot study is proposed that will assess if the proposed online physical exercise programme could be performed in people with HF. Thirty participants will be allocated at random into two groups: Group A will receive up to 24 exercise sessions and up-to 3 lifestyle workshops, in addition to usual care over a 2-month period. Group B will receive a self-care exercise programme (≥3 sessions per week) for a two-month period in addition to usual care. Prior to the group random allocation, online assessments will be performed including demographics and clinical history, the ability to perform daily activities, sedentary or physical activity habits and quality of life. The assessments including interviews to assess participant's experiences will be repeated at 2 months

Official Title
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Pilot Testing of an Online Rehabilitation Intervention Aiming to Support People With Heart Failure.

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Exercise
* Procedure: Self-managed exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 yrs. of either gender Confirmed diagnosis (by echocardiography) of HF reduced left ventricular ejection fraction Sinus rhythm N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) is >400 ng/L at the time of referral to the diagnostic clinic if in sinus rhythm. Ability to exercise Exclusion Criteria: Non-ambulant status Current pregnancy Scheduled major cardiac surgery The presence of an ICD or CRT-D device Severe pulmonary hypertension defined as systolic PAP of >60 mmHg NYHA function class IV Lack of internet connection Inability/unwillingness to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel Intervention<br>Novel Intervention Exercise group. | Procedure: Exercise<br>* Group A participants will be invited to attend up to 24 exercise sessions (2 sessions per week and a 3rd optional) and 2 virtual (online; a 3rd will be optional) HF workshops over 8 weeks. All sessions will be delivered via online platforms, with 1 facilitator supporting up to 8 participants simultaneously in each session.<br>|
| Active Comparator: Control<br>Self-managed Exercise group. | Procedure: Self-managed exercise<br>* Group B participants will be provided with a self-care exercise programme. The exercise programme will be home-based with a mixture of online video calls and telephone support contacts, alternating once every other week. The video or telephone contacts will be mutually agreed by the patient and the facilitator at a mutually convenient time and will aim to support Group B participants, by offering advice and tracking progress. Patients will be provided with two exercise programmes: I) a chair-based exercise programme (DVD will be provided), and ii) a progressive walking training programme (a manual will be provided). Patients will be advised to exercise ≥3 times per week, starting from their own personal level and gradually building up over 8 weeks in session's duration, frequency of sessions per week, and walking pace.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Number of sessions completed. | 2 months | 
| Acceptability of procedures. | Acceptability of procedures will be assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups | 2 months | 
| Recruitment rates. | Recruitment rates will be measured as rate of invited participants who are eligible and consenting | 2 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-second chair-stand test | 30-second chair-stand test | Baseline. | 
| 30-second chair-stand test | 30-second chair-stand test | 2 months | 
| Step in place test | Step in place test (2mins) | Baseline | 
| Step in place test | Step in place test (2mins) | 2 months | 
| arm curl test | arm curl test | baseline | 
| arm curl test | arm curl test | 2 months | 
| EQ5D-5L | The EQ5D-5L questionnaire will be completed, to support assessment of quality of life. | baseline | 
| EQ5D-5L | The EQ5D-5L questionnaire will be completed, to support assessment of quality of life. | 2 months | 
| MLHFQ | The MLHFQ questionnaire will be completed, to support assessment of quality of life. | Baseline. | 
| MLHFQ | The MLHFQ questionnaire will be completed, to support assessment of quality of life. | 2 months | 
| BREQ-2 | The BREQ-2 questionnaire will be completed, to support assessment of quality of life. | Baseline. | 
| BREQ-2 | The BREQ-2 questionnaire will be completed, to support assessment of quality of life. | 2 months |