Heart FailurePORIAS-HFNCT04797481
Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF).
A study testing Exercise and Self-managed exercise in people with Heart Failure, run by Sheffield Hallam University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise and Self-managed exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, Yorkshire, S10 2BP
About this study
Official title: 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
- Conditions
- Heart Failure
- Being tested
- Exercise, Self-managed exercise
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
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 exerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Novel Intervention | Experimental | Novel Intervention Exercise group. Receives: Procedure: Exercise |
| Control | Active comparator | Self-managed Exercise group. Receives: Procedure: Self-managed exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Number of sessions completed.
Measured: 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
Measured: 2 months
Recruitment rates.
Recruitment rates will be measured as rate of invited participants who are eligible and consenting
Measured: 2 months.
Secondary outcomes (12)
30-second chair-stand test
30-second chair-stand test
Measured: Baseline.
30-second chair-stand test
30-second chair-stand test
Measured: 2 months
Step in place test
Step in place test (2mins)
Measured: Baseline
Step in place test
Step in place test (2mins)
Measured: 2 months
arm curl test
arm curl test
Measured: baseline
arm curl test
arm curl test
Measured: 2 months
EQ5D-5L
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
Measured: baseline
EQ5D-5L
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
Measured: 2 months
MLHFQ
The MLHFQ questionnaire will be completed, to support assessment of quality of life.
Measured: Baseline.
MLHFQ
The MLHFQ questionnaire will be completed, to support assessment of quality of life.
Measured: 2 months
BREQ-2
The BREQ-2 questionnaire will be completed, to support assessment of quality of life.
Measured: Baseline.
BREQ-2
The BREQ-2 questionnaire will be completed, to support assessment of quality of life.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jun 2023
- Primary completion28 Oct 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Markos Klonizakis, D.Phil, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797481
- Sponsor's protocol ID
- ER30631161
- Acronym
- PORIAS-HF
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of an Online Rehabilitation Intervention Aiming to Support People With Heart Failure.
- ClinicalTrials.gov ID
- NCT04797481
- Acronym / sponsor ID
- PORIAS-HF / ER30631161
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- King's College London, Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Intervention | Experimental | Procedure: ExerciseNovel Intervention Exercise group. |
| Control | Active comparator | Procedure: Self-managed exerciseSelf-managed Exercise group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseGroup 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. | Procedure or surgery | Novel Intervention |
| Self-managed exerciseGroup 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. | Procedure or surgery | Control |
Primary outcome
Adherence
Time frame: 2 months
Number of sessions completed.
Acceptability of procedures.
Time frame: 2 months
Acceptability of procedures will be assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups
Recruitment rates.
Time frame: 2 months.
Recruitment rates will be measured as rate of invited participants who are eligible and consenting
12 secondary outcomes
30-second chair-stand test
Time frame: Baseline.
30-second chair-stand test
Time frame: 2 months
Step in place test
Time frame: Baseline
Step in place test
Time frame: 2 months
arm curl test
Time frame: baseline
arm curl test
Time frame: 2 months
EQ5D-5L
Time frame: baseline
EQ5D-5L
Time frame: 2 months
MLHFQ
Time frame: Baseline.
MLHFQ
Time frame: 2 months
BREQ-2
Time frame: Baseline.
BREQ-2
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markos Klonizakis, D.Phil principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Self-managed exercise in people with Heart Failure, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.