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

Not Applicable

• Conditions: Heart Failure
• Interventions: Procedure: Exercise; Procedure: Self-managed exercise

• Registration Number: NCT04797481
• Lead Sponsor: Sheffield Hallam University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Study Start: 2022-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-02-28
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel Intervention	Exercise	Novel Intervention Exercise group.
Control	Self-managed exercise	Self-managed Exercise group.

Primary Outcome Measures

Name	Time	Method
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
Adherence	2 months	Number of sessions completed.

Secondary Outcome Measures

Name	Time	Method
EQ5D-5L	2 months	The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
30-second chair-stand test	2 months	30-second chair-stand test
MLHFQ	2 months	The MLHFQ questionnaire will be completed, to support assessment of quality of life.
BREQ-2	2 months	The BREQ-2 questionnaire will be completed, to support assessment of quality of life.
Step in place test	2 months	Step in place test (2mins)
arm curl test	2 months	arm curl test

Trial Locations

Locations (1)

Sheffield Hallam University; 🇬🇧 Sheffield, Yorkshire, United Kingdom