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临床试验/NCT04797481
NCT04797481进行中(未招募)不适用

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

Sheffield Hallam University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Adherence

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Novel Intervention

Experimental

Novel Intervention Exercise group.

干预措施: Exercise (Procedure)

Control

Active Comparator

Self-managed Exercise group.

干预措施: Self-managed exercise (Procedure)

结局指标

主要结局

Adherence

时间窗: 2 months

Number of sessions completed.

Acceptability of procedures.

时间窗: 2 months

Acceptability of procedures will be assessed by examining reasons for drop-out in discontinuing participants and comparing attrition between groups

Recruitment rates.

时间窗: 2 months.

Recruitment rates will be measured as rate of invited participants who are eligible and consenting

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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