Heart Failure
Conditions
Brief summary
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
Interventions
PROCEDUREExercise
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.
PROCEDURESelf-managed exercise
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.
Sponsors
Sheffield Hallam University
King's College London
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 2 months | Number of sessions completed. |
| Acceptability of procedures. | 2 months | Acceptability of procedures will be assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups |
| Recruitment rates. | 2 months. | Recruitment rates will be measured as rate of invited participants who are eligible and consenting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-second chair-stand test | Baseline. | 30-second chair-stand test |
| Step in place test | Baseline | Step in place test (2mins) |
| arm curl test | baseline | arm curl test |
| EQ5D-5L | baseline | The EQ5D-5L questionnaire will be completed, to support assessment of quality of life. |
| MLHFQ | Baseline. | The MLHFQ questionnaire will be completed, to support assessment of quality of life. |
| BREQ-2 | Baseline. | The BREQ-2 questionnaire will be completed, to support assessment of quality of life. |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORMarkos Klonizakis, D.Phil
Sheffield Hallam University
Outcome results
None listed