NCT04797481Active, not recruiting
Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF).
Pilot Testing of an Online Rehabilitation Intervention Aiming to Support People With Heart Failure.
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Mar 2021
- Start date
- 1 Jun 2023
- Primary completion date
- 28 Oct 2026
- Lead sponsor
- Sheffield Hallam University
- Diseases
- Heart failure
- NCT number
- NCT04797481
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Jun 2023 to the primary completion date, 28 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Scheduled major cardiac surgery
- Severe pulmonary hypertension defined as systolic PAP of \>60 mmHg
Other
- Non-ambulant status
- Current pregnancy
- The presence of an ICD or CRT-D device
- NYHA function class IV
- Lack of internet connection
- Inability/unwillingness to give informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheffield Hallam University Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.