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| ID | Type | Description | Link |
|---|---|---|---|
| #2017T051 | Other Grant/Funding Number | senior E-Dekker grant |
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The goal of this clinical trial is to learn about the effect of a booster program aiming to lower daily sitting time (SIT LESS Booster program) compared to usual care in patient with coronary heart problems. The main question it aims to answer is: What is the effect of the SIT LESS Booster on sedentary time and physical activity levels in patient with coronary artery disease who participated in cardiac rehabilitation.
Participants will be randomized into 2 groups:
Objectively measured changes in daily sitting time from pre- to post SIT LESS Booster will be compared between groups to see if participants in the SIT LESS Booster group are able to reduce daily sedentary time more compared to participants in the control group.
High levels of sedentary time (ST) are observed in patients with coronary artery disease (CAD) and are associated with adverse health outcomes. Behavioural interventions targeting ST are effective in the short-term, but effects seem to diminish at long-term follow-up. Short-term (telephonic) booster programs can induce sustainable physical activity behavioural changes. However, the effects of a booster ST reduction program are unknown. Therefore, we aim to assess the effect of the SIT LESS Booster on sedentary time and physical activity levels in patient with coronary artery disease who participated in cardiac rehabilitation.
All participants took already part in a special cardiac rehabilitation program aiming to lower daily sitting time between May 2021 and April 2022. For this study, they will be randomized into 2 groups:
The SIT LESS Booster program consists of:
In both groups, daily sitting time will be measured at the start of the study and at the end of the SIT LESS Booster program using the ActivPAL.
Data analysis will be conducted using R and p-values of <0.05 will be considered statistically significant. Changes in daily ST will be compared between groups using a linear mixed model.
This trial was approved by the Medical Ethics Committee of the Radboud university medical center (NL72604.091.20)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group will receive usual care alone | |
| SIT LESS Booster | Experimental | The intervention group will receive usual care in combination with the remote 3-week SIT LESS Booster program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIT LESS Booster | Behavioral | Patients allocated to the SIT LESS Booster group receive usual care in combination with the SIT LESS Booster program. The SIT LESS Booster program consists of: 1) The use of the pocket-worn activity tracker (Activ8sit). The activity tracker can be connected to an app to track the daily sitting time. Besides, the device buzzes when a person sits more than 30 consective minutes a s a reminder to stand up and move; 2) Telephone consultation (TC1) during which the researcher and patients will reactivate knowledge on the detrimental health effects of SB, discuss patients' personal goals and motivation, and collaboratively set action plans for reducing SB in the upcoming week (±20 minutes); and 3) Weekly telephone calls (TC2 and TC3) to evaluate sedentery behaviour of the preceding week (±10 minutes). The SIT LESS Booster will be delivered completely remote |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Sedentary time (h/day) | Daily sedentary time as measured with the ActivPAL during 7 days | Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program |
| Measure | Description | Time Frame |
|---|---|---|
| Number of prolonged sedentary bouts per day | Daily number of prolonged sedentary bouts (>30 min/day) as measured with the ActivPAL during 7 days | Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program |
| Prevalence of a sitting time >9.5 h/day |
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Inclusion Criteria:
• Participation in the SIT LESS intervention group of the SIT LESS study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thijs MH Eijsvogels, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35692440 | Background | van Bakel BMA, Kroesen SH, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, Dam J, Janssen AM, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Sedentary Behaviour Intervention as a Personalised Secondary Prevention Strategy (SIT LESS) for patients with coronary artery disease participating in cardiac rehabilitation: rationale and design of the SIT LESS randomised clinical trial. BMJ Open Sport Exerc Med. 2022 May 24;8(2):e001364. doi: 10.1136/bmjsem-2022-001364. eCollection 2022. | |
| 36788615 |
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In line with the Open Science initiative and FAIR principles, IPD will be available on reasonable request via the corresponding author.
IPD will be availabe after publication of the results by the research team.
All data will be stored in the Digital Research Environment (DRE, mydre. org), an online, cloud- based, globally available research platform. The DRE facilitates users to collaborate on research projects within the boundaries of data management regulations (General Data Protection Regulation and Good Clinical Practice compliant) in a flexible and safe way regarding security, Information and Communication Technology (ICT) infrastructure and audit trail.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2023 | Mar 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2024 | Mar 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
Prevalence of an average sitting time >9.5 h/day measured by the ActivPAL for 7 consective days |
| Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program |
| daily light-intensity physical activity time (h/day) | Daily time spent in light-intensity physical activity (<3 METs) measured by the ActivPAL for 7 consective days | Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program |
| daily moderate-to-vigorous-intensity physical activity time (h/day) | Daily time spent in moderate to vigorous intensity physical activity (>3 METs) measured by the ActivPAL for 7 consective days | Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program |
| daily step count (steps/day) | daily step count measured by the ActivPAL for 7 consective days | Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program |
| Uptake of the SIT LESS Booster | Number of participants participating in the SIT LESS Booster study compared to the number of eligible participants | from the start of recruitment (end August 2023) until 3 months later |
| Average wear time of the Activ8 in the SIT LESS Booster group | Adherence to the use of the Activ8 (wear time) measured during the intervention period in the intervention group | During the 3-week SIT LESS Booster program |
| Number of completed telephone calls in the SIT LESS Booster group | Number of completed telephone calls of participants in the SIT LESS Booster group | During the 3-week SIT LESS Booster program |
| Background |
| van Bakel BMA, Kroesen SH, Bakker EA, van Miltenburg RV, Gunal A, Scheepmaker A, Aengevaeren WRM, Willems FF, Wondergem R, Pisters MF, de Bruin M, Hopman MTE, Thijssen DHJ, Eijsvogels TMH. Effectiveness of an intervention to reduce sedentary behaviour as a personalised secondary prevention strategy for patients with coronary artery disease: main outcomes of the SIT LESS randomised clinical trial. Int J Behav Nutr Phys Act. 2023 Feb 14;20(1):17. doi: 10.1186/s12966-023-01419-z. |
| 40112182 | Derived | Kroesen SH, van Bakel BMA, de Bruin M, Pisters MF, Ortega FB, Hopman MTE, Thijssen DHJ, Bakker EA, Eijsvogels TMH. A remote booster program to attenuate sedentary behaviour in patients with coronary artery disease: A Randomized Controlled Trial. Eur J Prev Cardiol. 2025 Mar 20:zwaf162. doi: 10.1093/eurjpc/zwaf162. Online ahead of print. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001519 | Behavior |