Radboudumc
Nijmegen, Gelderland, 6525GA, Netherlands
NCT Number: NCT06038188
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:
1. Control group who receives usual care; 2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster program.
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nijmegen, Gelderland, 6525GA, Netherlands
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily sedentary time as measured with the ActivPAL during 7 days
Time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily number of prolonged sedentary bouts (>30 min/day) as measured with the ActivPAL during 7 days
Time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Prevalence of an average sitting time >9.5 h/day measured by the ActivPAL for 7 consective days
Time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily time spent in light-intensity physical activity (<3 METs) measured by the ActivPAL for 7 consective days
Time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Daily time spent in moderate to vigorous intensity physical activity (>3 METs) measured by the ActivPAL for 7 consective days
Time frame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
daily step count measured by the ActivPAL for 7 consective days
Time frame: from the start of recruitment (end August 2023) until 3 months later
Number of participants participating in the SIT LESS Booster study compared to the number of eligible participants
Time frame: During the 3-week SIT LESS Booster program
Adherence to the use of the Activ8 (wear time) measured during the intervention period in the intervention group
Time frame: During the 3-week SIT LESS Booster program
Number of completed telephone calls of participants in the SIT LESS Booster group
Radboud University Medical Center
Other
Effectiveness of a Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease: a Randomized Clinical Trial.
Acronym: BOOSTSITLESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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