Clinical trial NCT06124248: Effectiveness of the RISE Intervention
Official title: RISE Intervention: Heading to Sustainable Movement Behavioural Change in People with Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Behaviour
Stroke
Keywords: Physical activity
Cardiovascular diseases
Sedentary time
Sitting time
Movement behaviours
Behaviour change
Sedentary behaviour
Stroke
Secondary prevention
Costs
Cost analysis
Cost effectiveness
MACE
Prevention
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Participants in the control group receive usual care, according to hospital specific guidelines.

Main study parameters/endpoints: Effectiveness of RISE intervention on preventing major adverse cardiovascular events.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden and risk of participating in the RISE intervention are considered low. The participants will receive a blended coaching intervention to reduce and interrupt their sedentary behaviour. The blended intervention includes ten face-to-face or online sessions of a primary care physiotherapist, wearing an activity monitor during the intervention period, and support from the smartphone application. During the intervention people will be encouraged to sit less and move more. The participant will participate in a baseline and post intervention measurements. This includes wearing an activity monitor, questionnaires and performing physical tests. All measurements are non-invasive. Participants can shower and perform all other daily activities while wearing the activity monitor. The other measurements will take about 3.5 hours in total, and will be carried out online or at people\&amp;amp;amp;amp;amp;amp;amp;#39;s homes. Included participants are physically capable of performing these physical activities and are coached by a physiotherapist. Therefore, the risk involved in participating is low. Additional burden of the intervention is low since visits of the physiotherapist will be at home or online

The possible benefits of participating in the study are: 1) insights in own movement behaviour and 2) (if someone is randomized to the RISE intervention group) the RISE intervention may help to reduce sedentary time, which may lower the risk on recurrent stroke.

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in the baseline measurement of the intervention study, a subject must meet all of the following criteria:

1. Aged 18 years or older;
2. All types of first-ever stroke diagnosed in hospital within six months before start of the RISE intervention;
3. Able to walk independently, as defined by a Functional ambulation categories score of at least 3;
4. Independent regarding activities of daily living pre-stroke, as defined by a Barthel Index score of \>18;
5. Discharged to the home-setting;
6. Not participating in a physical rehabilitation program lasting ≥ 3 months;
7. Given their written informed consent.

Exclusion Criteria:

A potential subject will be excluded from participation in this study if:

1. The participant has insufficient knowledge or is cognitively unable to understand the Dutch language of the intervention content;
2. 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;

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
Secondary outcomes:
measure: Cost-Effectiveness
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
measure: Quality of life
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
measure: Patients' healthcare utilization and patients' (unpaid) productivity losses
timeFrame: T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
measure: 24-hour movement behaviour (sedentary behaviour, physical activity, sleep)
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
Other outcomes:
measure: Safety during the RISE intervention and follow-up measurements.
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T3 (9 months), T4 (12 months)
measure: Physical functioning and participation
timeFrame: T0 (baseline), T1 (3 months)
measure: Sleep quality and quantity
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
measure: Fatigue
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
measure: Stroke physical impact
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
measure: Walking speed
timeFrame: T0 (baseline), T1 (3 months)
measure: Self-efficacy
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
measure: Self-management skills
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
measure: Compliance to the RISE intervention
timeFrame: T1 (3 months)
measure: End-user satisfaction, feasibility and acceptability
timeFrame: T1 (3 months)
measure: Mental health status
timeFrame: T0 (baseline), T1 (3 months), T2 (6 months), T4 (12 months)
measure: Patient characteristics
timeFrame: T0 (baseline), T1 (3 months)
Locations:
city: Vught
country: Netherlands
facility: Fysiofit Vught
state: Brabant
city: 's-Hertogenbosch
country: Netherlands
facility: Fysio 4 Den Bosch
state: Noord-Brabant
city: Eersel
country: Netherlands
facility: Meras & Vital Fysiotherapie
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: PMC Eindhoven
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Stroomz Prinsejagt
state: Noord-Brabant
city: Geldrop
country: Netherlands
facility: Fysiotherapie Zesgehuchten
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: JVDI De Fysioclub
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: Fysiotherapie Rakthof
state: Noord-Brabant
city: Rosmalen
country: Netherlands
facility: Vivent
state: Noord-Brabant
city: Valkenswaard
country: Netherlands
facility: Van Hoof, centrum voor therapie en gezondheid
state: Noord-Brabant
city: Vlijmen
country: Netherlands
facility: Fysio Annette de Gooijer
state: Noord-Brabant
city: Vught
country: Netherlands
facility: Fysio Vught Noord
state: Noord-Brabant
city: Breukelen
country: Netherlands
facility: Fysiotherapie Beelen
state: Utrecht
city: Houten
country: Netherlands
facility: Fysiotherapie Zorgspectrum Houten eerstelijn
state: Utrecht
city: Ijsselstein
country: Netherlands
facility: Fysiotherapie Groene Biezen
state: Utrecht
city: Mijdrecht
country: Netherlands
facility: MTCFysio
state: Utrecht
city: Veenendaal
country: Netherlands
facility: Rembrandt fysiotherapie en revalidatie
state: Utrecht
city: Wijk bij Duurstede
country: Netherlands
facility: Fysio Frankenhof
state: Utrecht
city: Woerden
country: Netherlands
facility: Synergy Fysiotherapie
state: Utrecht
city: Zeist
country: Netherlands
facility: Van Tongeren Fysiotherapeuten
state: Utrecht
city: Utrecht
country: Netherlands
facility: Leidsche Rijn Julius Gezondheidscentra
Study officials:
affiliation: UMC Utrecht Brain Center and Fontys University of Applied Sciences
name: Martijn F Pisters, Dr.
role: PRINCIPAL_INVESTIGATOR
References: