Clinical trial NCT04797481: Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF).
Official title: Pilot Testing of an Online Rehabilitation Intervention Aiming to Support People With Heart Failure.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: King's College London
name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2021-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Adherence
timeFrame: 2 months
measure: Acceptability of procedures.
timeFrame: 2 months
measure: Recruitment rates.
timeFrame: 2 months.
Secondary outcomes:
measure: 30-second chair-stand test
timeFrame: Baseline.
measure: 30-second chair-stand test
timeFrame: 2 months
measure: Step in place test
timeFrame: Baseline
measure: Step in place test
timeFrame: 2 months
measure: arm curl test
timeFrame: baseline
measure: arm curl test
timeFrame: 2 months
measure: EQ5D-5L
timeFrame: baseline
measure: EQ5D-5L
timeFrame: 2 months
measure: MLHFQ
timeFrame: Baseline.
measure: MLHFQ
timeFrame: 2 months
measure: BREQ-2
timeFrame: Baseline.
measure: BREQ-2
timeFrame: 2 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
state: Yorkshire
Study officials:
affiliation: Sheffield Hallam University
name: Markos Klonizakis, D.Phil
role: PRINCIPAL_INVESTIGATOR
References: