The primary aim of this study is to compare the effect of the SIT LESS intervention versus usual treatment on sedentary time in patients with coronary artery disease directly after cardiac rehabilitation.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Exercise training is the cornerstone in cardiac rehabilitation for patients
with coronary artery disease. However, potential improvements in physical
activity are often temporarily and most patients with coronary artery disease
show high levels of sedentary time. Current cardiac rehabilitation programs do
not specifically target sedentary time and no promising interventions to reduce
sedentary time amongst patients with coronary artery disease have been
identified in literature. We have therefore developed the SIT LESS
intervention, which is based on an existing effective and cost-effective
behaviour change intervention (AIMS) and has been adapted together with
patients and healthcare professionals to an add-on module in cardiac
rehabilitation treatment.
Study objective
The primary aim of this study is to compare the effect of the SIT LESS
intervention versus usual treatment on sedentary time in patients with coronary
artery disease directly after cardiac rehabilitation.
Study design
A randomised controlled trial comparing SIT LESS to usual cardiac rehab.
Intervention
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
create awareness of prolonged sitting bouts in order to reduce their sedentary
behaviour. During regular follow-up consultations with the nurse, personalized
visual reports of (in)activity will be evaluated to enhance patients awareness
of their (in)activity and identify any problems and solutions to reduce
inactivity. The control group will receive usual treatment only.
Study burden and risks
The nature and extent of the burden and risks associated with the intervention
and measurements are negligible since the measurements are non-invasive. Using
the activity monitor may be perceived as burdensome by some patients, but if
patients perceive these to outweigh the benefits of the intervention they can
discontinue with the monitor. All patients will continue to receive
treatment-as-usual.
Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL72604.091.20 |