Sitting interruption treatment as a personalized secondary prevention strategy in patients with coronary artery disease: a randomized clinical trial

Sitting interruption treatment as a personalized secondary prevention strategy in patients with coronary artery disease: a randomized clinical trial - SIT LESS RCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49484

Enrollment

212

Registered

2020-03-24

Start date

2021-03-30

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease ischemic heart disease

Interventions

A 12-week, nurse-delivered intervention will be provided in addition to usual treatment. During the baseline visit, nurses will use pre-tested materials for informing and motivating patients

and collaboratively set goals and plans for reducing sedentary behaviours. Patients will then receive an activity tracker that identifies bouts of physical inactivity and provides notifications to

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Diagnosed with coronary artery disease (ST-elevation myocardial infarction (STEMI) - non-ST-elevation myocardial infarction (NSTEMI) - UAP (unstable angina pectoris) - stable angina pectoris (AP)) • Referral to cardiac rehabilitation • Older than 18 years of age • Able to understand and perform study related procedures

Exclusion criteria

Exclusion criteria: • Unable to give informed consent • Wheelchair-bounded / not physically able to stand or walk. • Language barrier • Coronary arterial bypass graft surgery expected within 8 weeks after inclusion • New York Heart Association class III or IV heart failure • Participation in another interventional study targeting SB or PA

Design outcomes

Primary

Measure	Time frame
Primary endpoint is sitting time in minutes per day. To achieve 80% power (2-sided test, alpha 0.05), assuming 15% dropout and a reduction of at least 60 minutes per day sitting time in the intervention group (compared to expected reduction of 30 minutes per day in the control group), 212 patients will need to be recruited.	—

Secondary

Measure	Time frame
Secondary outcomes are quality of life, the Patient Activation Measure (PAM), which is validated to assess patients* competency for self-management and light and moderate-to-vigorous physical activities, number of (prolonged) sitting bouts and cardiorespiratory fitness. Tertiary outcomes include incidence of adverse outcomes during 5 years of follow-up.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)