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临床试验/NCT06124248
NCT06124248招募中不适用

RISE Intervention: Heading to Sustainable Movement Behavioural Change in People with Stroke

UMC Utrecht21 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年11月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
UMC Utrecht
入组人数
1,000
试验地点
21
主要终点
Major Adverse Cardiovascular Events (MACE)

研究概览

简要总结

Study aim:

Primarily, to investigate the effectiveness of the RISE blended behaviour change intervention in people with a first stroke to prevent major adverse cardiovascular events (i.e., recurrent stroke or TIA, acute coronary events and cardiovascular death, MACE) after 1 year follow-up compared to standard care, and cost-effectiveness. For this aim, 376 persons are enrolled in the experimental group and 376 in the control group. Considering loss to follow up, it is expected that around 950-1000 patients need to be included during baseline measurement in total.

Additionally, to determine the effectiveness of the RISE intervention on reducing sedentary behaviour after discharge from acute hospital care in community dwelling people with a first-ever stroke, who have a sedentary movement behavioural pattern (so called 'sedentary prolongers' and 'sedentary movers') in comparison to usual care, at the end of the intervention period (T1). For this aim, 59 persons are enrolled in the experimental group and 59 in the control group. Considering loss to follow up, it is expected that around 197 patients need to be included during baseline measurement in total.

Who can participate? People aged over 18, who return home after acute care with a first-ever stroke, who are independent in walking with or without a walking aid, will be included in the RISE intervention study.

What does the study involve? In this clinical randomized controlled trial, participants with first-ever stroke and a sedentary movement pattern will be included and randomly assigned to either the experimental group who will receive RISE intervention and usual care or the control group who will receive usual care. Primary and secondary outcome will be measured at baseline, post-treatment and six, nine and 12 months post-randomisation.

详细描述

Rationale: People who have suffered a stroke are at high risk of functional decline, recurrent stroke and premature mortality. High amounts of sedentary behaviour, accumulated in prolonged bouts and low amounts of moderate to vigorous physical activity increase the risk of cardiovascular disease. Based on earlier research it is expected that a healthier balance in the 24h activity pattern (sedentary time, physical activity and sleep) reduces the risk of a second cardiovascular event. To support patients with stroke to strike the balance in their 24h activity pattern, a behavioural change coaching intervention focusing on reducing and interrupting their sedentary time was designed. A pilot study has been performed, and the RISE intervention seems feasible in reducing sedentary behaviour in people after stroke.

Objective: To determine the effectiveness of the RISE intervention on preventing major adverse cardiovascular effects (MACE), after discharge from acute hospital care in community dwelling people after first-ever stroke, who have a sedentary movement behavioural pattern. In addition, the effects on 24h activity pattern, cost-effectiveness, and usability of the RISE intervention will be investigated.

Study design: In this clinical randomized controlled trial, participants with first-ever stroke and a sedentary movement pattern will be included and randomly assigned to either the experimental group who will receive RISE intervention and usual care or the control group who will receive usual care. Primary and secondary outcomes will be measured at baseline, post-treatment (four months), and six, nine, and 12 months post-randomisation.

Study population: People aged over 18, who return home after acute care with a first-ever stroke, who are independent in walking with or without a walking aid, will be included in the RISE intervention study.

Intervention (if applicable): Participants will receive the RISE intervention, a 15-weeks blended behavioural intervention, where a primary care physiotherapist coaches participants on striking the balance in their 24h activity pattern, with a focus on reducing and interrupting their sedentary time. This will subsequently lead to an increase in physical activity. Next to that, insights into their personal sleep pattern, sleep hygiene rules and advices will be provided. Primary care physiotherapists coach people with a first-ever stroke in their home setting by using behaviour change techniques and the RISE eCoaching system. The RISE eCoaching system consists of 1) an activity monitor, 2) a smartphone application that provides real-time feedback and contains e-learning modules, 3) a monitoring dashboard for the physiotherapist. Participants receive participatory support from someone from their social network (e.g., partner or close friend) who joins them in the intervention (see image 1).

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
Single (Investigator)

盲法说明

The investigator who carries out the T1 follow-up measurement (end of the intervention period), will be blinded for treatment allocation.

入排标准

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

入选标准

  • •In order to be eligible to participate in the baseline measurement of the intervention study, a subject must meet all of the following criteria:
  • •Aged 18 years or older;
  • •All types of first-ever stroke diagnosed in hospital within six months before start of the RISE intervention;
  • •Able to walk independently, as defined by a Functional ambulation categories score of at least 3;
  • •Independent regarding activities of daily living pre-stroke, as defined by a Barthel Index score of >18;
  • •Discharged to the home-setting;
  • •Not participating in a physical rehabilitation program lasting ≥ 3 months;
  • •Given their written informed consent.

排除标准

  • •A potential subject will be excluded from participation in this study if:
  • •The participant has insufficient knowledge or is cognitively unable to understand the Dutch language of the intervention content;
  • •The participant has severe comorbidities that withhold that person from safely reducing and interrupting their sedentary time (e.g. sever pulmonary diseases, hart failure or malignity's) as determined with the Physical Activity Readiness Questionnaire;

研究组 & 干预措施

Experimental group

Experimental

RISE intervention and usual care

干预措施: RISE intervention (Behavioral)

Control group

No Intervention

Usual care

结局指标

主要结局

Major Adverse Cardiovascular Events (MACE)

时间窗: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)

MACE, a composite of clinical end points of recurrent stroke or Transcient Ischaemic Attack (TIA) (definition in American Heart Association guidelines (44)), acute coronary events, and cardiovascular death. Stroke recurrence will be diagnosed by acute neurological symptoms and signs, and confirmed by magnetic resonance imaging. Acute coronary events (myocardial infarction (MI), cardiac revascularization, hospitalization with unstable angina) are diagnosed according to Consensus Conference of the European College of Cardiology and American College of Cardiology criteria (45). Deaths are regarded to be attributable to a cardiovascular cause (fatal MI, fatal stroke (i.e. death within 1 month of MI or stroke), sudden death caused by definite coronary artery disease, congestive heart failure) unless a non-cardiac death could be confirmed. This information about MACE will be collected at T1, T2, T3 and T4 using patient records from general practitioners and a questionnaire to participants.

次要结局

  • Cost-Effectiveness(T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months))
  • Quality of life(T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months))
  • Patients' healthcare utilization and patients' (unpaid) productivity losses(T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months))
  • 24-hour movement behaviour (sedentary behaviour, physical activity, sleep)(T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months))

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martijn F. Pisters, PhD, PT

Principal Investigator

UMC Utrecht

研究点 (21)

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