Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF). (PORIAS-HF)
Primary Purpose
Heart Failure
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Self-managed exercise
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- Sheffield Hallam University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Novel Intervention
Control
Arm Description
Novel Intervention Exercise group.
Self-managed Exercise group.
Outcomes
Primary Outcome Measures
Adherence
Number of sessions completed.
Acceptability of procedures.
Acceptability of procedures will be assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups
Recruitment rates.
Recruitment rates will be measured as rate of invited participants who are eligible and consenting
Secondary Outcome Measures
30-second chair-stand test
30-second chair-stand test
30-second chair-stand test
30-second chair-stand test
Step in place test
Step in place test (2mins)
Step in place test
Step in place test (2mins)
arm curl test
arm curl test
arm curl test
arm curl test
EQ5D-5L
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
EQ5D-5L
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
MLHFQ
The MLHFQ questionnaire will be completed, to support assessment of quality of life.
MLHFQ
The MLHFQ questionnaire will be completed, to support assessment of quality of life.
BREQ-2
The BREQ-2 questionnaire will be completed, to support assessment of quality of life.
BREQ-2
The BREQ-2 questionnaire will be completed, to support assessment of quality of life.
Full Information
NCT ID
NCT04797481
First Posted
March 4, 2021
Last Updated
September 12, 2022
Sponsor
Sheffield Hallam University
Collaborators
King's College London, Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04797481
Brief Title
Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF).
Acronym
PORIAS-HF
Official Title
Pilot Testing of an Online Rehabilitation Intervention Aiming to Support People With Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Hallam University
Collaborators
King's College London, Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Novel Intervention
Arm Type
Experimental
Arm Description
Novel Intervention Exercise group.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Self-managed Exercise group.
Intervention Type
Procedure
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Self-managed exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence
Description
Number of sessions completed.
Time Frame
2 months
Title
Acceptability of procedures.
Description
Acceptability of procedures will be assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups
Time Frame
2 months
Title
Recruitment rates.
Description
Recruitment rates will be measured as rate of invited participants who are eligible and consenting
Time Frame
2 months.
Secondary Outcome Measure Information:
Title
30-second chair-stand test
Description
30-second chair-stand test
Time Frame
Baseline.
Title
30-second chair-stand test
Description
30-second chair-stand test
Time Frame
2 months
Title
Step in place test
Description
Step in place test (2mins)
Time Frame
Baseline
Title
Step in place test
Description
Step in place test (2mins)
Time Frame
2 months
Title
arm curl test
Description
arm curl test
Time Frame
baseline
Title
arm curl test
Description
arm curl test
Time Frame
2 months
Title
EQ5D-5L
Description
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
Time Frame
baseline
Title
EQ5D-5L
Description
The EQ5D-5L questionnaire will be completed, to support assessment of quality of life.
Time Frame
2 months
Title
MLHFQ
Description
The MLHFQ questionnaire will be completed, to support assessment of quality of life.
Time Frame
Baseline.
Title
MLHFQ
Description
The MLHFQ questionnaire will be completed, to support assessment of quality of life.
Time Frame
2 months
Title
BREQ-2
Description
The BREQ-2 questionnaire will be completed, to support assessment of quality of life.
Time Frame
Baseline.
Title
BREQ-2
Description
The BREQ-2 questionnaire will be completed, to support assessment of quality of life.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markos Klonizakis, D.Phil
Organizational Affiliation
Sheffield Hallam University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Hallam University
City
Sheffield
State/Province
Yorkshire
ZIP/Postal Code
S10 2BP
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF).
We'll reach out to this number within 24 hrs