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

NCT04797481 | Enrolling By Invitation

• 1 other identifier: ER30631161
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 30-second chair-stand test

  Baseline.

• 30-second chair-stand test

  2 months

• Step in place test

  Baseline

• Step in place test

  2 months

• arm curl test

  baseline

Study Arms (2)

Novel Intervention

EXPERIMENTAL

Novel Intervention Exercise group.

Procedure: Exercise

Control

ACTIVE COMPARATOR

Self-managed Exercise group.

Procedure: Self-managed exercise

Interventions

Exercise PROCEDURE

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.

Novel Intervention

Self-managed exercise PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• King's College London: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Sheffield Hallam University

Sheffield, Yorkshire, S10 2BP, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Markos Klonizakis, D.Phil

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 15, 2021
• Study Start: June 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: July 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)