Skip to main content
Clinical Trials/NCT04797481
NCT04797481
Enrolling by Invitation
N/A

Pilot Testing of an Online Rehabilitation Intervention Aiming to Support People With Heart Failure.

Sheffield Hallam University1 site in 1 country40 target enrollmentJune 1, 2022
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Sheffield Hallam University
Enrollment
40
Locations
1
Primary Endpoint
Adherence
Status
Enrolling by Invitation
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
July 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • EQ5D-5L(2 months)
  • 30-second chair-stand test(2 months)
  • MLHFQ(2 months)
  • BREQ-2(2 months)
  • Step in place test(2 months)
  • arm curl test(2 months)

Study Sites (1)

Loading locations...

Similar Trials