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

Heart Failure Clinical Trial

— PORIAS-HF  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04797481
• Other study ID #: ER30631161
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Sheffield Hallam University	Sheffield	Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
Sheffield Hallam University	King's College London, Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Number of sessions completed.	2 months
Primary	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
Primary	Recruitment rates.	Recruitment rates will be measured as rate of invited participants who are eligible and consenting	2 months.
Secondary	30-second chair-stand test	30-second chair-stand test	Baseline.
Secondary	30-second chair-stand test	30-second chair-stand test	2 months
Secondary	Step in place test	Step in place test (2mins)	Baseline
Secondary	Step in place test	Step in place test (2mins)	2 months
Secondary	arm curl test	arm curl test	baseline
Secondary	arm curl test	arm curl test	2 months
Secondary	EQ5D-5L	The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.	baseline
Secondary	EQ5D-5L	The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.	2 months
Secondary	MLHFQ	The MLHFQ questionnaire will be completed, to support assessment of quality of life.	Baseline.
Secondary	MLHFQ	The MLHFQ questionnaire will be completed, to support assessment of quality of life.	2 months
Secondary	BREQ-2	The BREQ-2 questionnaire will be completed, to support assessment of quality of life.	Baseline.
Secondary	BREQ-2	The BREQ-2 questionnaire will be completed, to support assessment of quality of life.	2 months