Remote 3-week Booster Intervention to Reduce Sedentary Time in Patients With Coronary Artey Disease

NCT ID: NCT06038188

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2023-12-31

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)

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

The control group will receive usual care alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

SIT LESS Booster

The intervention group will receive usual care in combination with the remote 3-week SIT LESS Booster program.

Group Type: EXPERIMENTAL

SIT LESS Booster

Intervention Type: 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

Interventions

SIT LESS Booster

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thijs MH Eijsvogels, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 35692440 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36788615 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40112182 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

#2017T051

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL72604.091.20

Identifier Type: -

Identifier Source: org_study_id