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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Exercise; Procedure: Self-managed exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Yorkshire
    • Sheffield, Yorkshire, United Kingdom, S10 2BP
      • Sheffield Hallam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel Intervention; Novel Intervention Exercise group.	Procedure: Exercise; 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.
Active Comparator: Control; Self-managed Exercise group.	Procedure: Self-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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheffield Hallam University
• Collaborators: King's College London; Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Markos Klonizakis, D.Phil, Sheffield Hallam University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ER30631161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No