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Tests treatment safety and results for Sedentary Behaviour
Official title Effectiveness of the RISE Intervention
ClinicalTrials.gov ID: NCT06124248
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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...
See the full eligibility 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:
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 's-Hertogenbosch, North Brabant, Netherlands
- Eersel, North Brabant, Netherlands
- Eindhoven, North Brabant, Netherlands
- Geldrop, North Brabant, Netherlands
- Helmond, North Brabant, Netherlands
- Rosmalen, North Brabant, Netherlands
- Valkenswaard, North Brabant, Netherlands
- Vlijmen, North Brabant, Netherlands
- Vught, North Brabant, Netherlands
- Breukelen, Utrecht, Netherlands
- Houten, Utrecht, Netherlands
- IJsselstein, Utrecht, Netherlands
- Mijdrecht, Utrecht, Netherlands
- Utrecht, Utrecht, Netherlands
- Veenendaal, Utrecht, Netherlands
- Wijk bij Duurstede, Utrecht, Netherlands
- Woerden, Utrecht, Netherlands
- Zeist, Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 's-Hertogenbosch, North Brabant, Netherlands; Eersel, North Brabant, Netherlands; Eindhoven, North Brabant, Netherlands; Geldrop, North Brabant, Netherlands; Helmond, North Brabant, Netherlands; Rosmalen, North Brabant, Netherlands and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.