Clinical trial NCT06038188: Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease
Official title: Effectiveness of a Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Cardiac rehabilitation
e-Health
Prevention
Sedentary lifestyle
Physical activity
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

1. Control group who receives usual care;
2. SIT LESS Booster group who receives usual care + a remote 3-week SIT LESS Booster program.

The SIT LESS Booster program consists of:

* Telephone consultation in which the participants are informed about the negative effects of high daily sitting time, discuss personal goals to lower daily sitting time and make an action plan to reach the goals.
* Use of a pocket-worn activity tracker to get insight in their own daily sitting time. The activity tracker can be connected to a smartphone application. Besides, the activity tracker buzzes when a person sits more than 30 consecutive minutes as a reminder to stand up.
* Weekly telephone calls to discuss the progress regarding their personal sit less goals.

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)

Eligibility criteria: Inclusion Criteria:

• Participation in the SIT LESS intervention group of the SIT LESS study

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

Primary outcomes:
measure: Daily Sedentary time (h/day)
timeFrame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
Secondary outcomes:
measure: Number of prolonged sedentary bouts per day
timeFrame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
measure: Prevalence of a sitting time >9.5 h/day
timeFrame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
measure: daily light-intensity physical activity time (h/day)
timeFrame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
measure: daily moderate-to-vigorous-intensity physical activity time (h/day)
timeFrame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
measure: daily step count (steps/day)
timeFrame: Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program
measure: Uptake of the SIT LESS Booster
timeFrame: from the start of recruitment (end August 2023) until 3 months later
measure: Average wear time of the Activ8 in the SIT LESS Booster group
timeFrame: During the 3-week SIT LESS Booster program
measure: Number of completed telephone calls in the SIT LESS Booster group
timeFrame: During the 3-week SIT LESS Booster program
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Thijs MH Eijsvogels, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.