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

Sheffield Hallam University

Status: Invitation-only

Conditions: Heart Failure

Treatments: Procedure: Exercise; Procedure: Self-managed exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04797481

ER30631161

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Novel Intervention

Experimental group

Description:

Novel Intervention Exercise group.

Treatment:

Procedure: Exercise

Control

Active Comparator group

Description:

Self-managed Exercise group.

Treatment:

Procedure: Self-managed exercise