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

NCT06038188 | Completed DMC

• 2 other identifiers: NL72604.091.20#2017T051
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

Cardiac rehabilitation; e-Health; Prevention; Sedentary lifestyle; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Number of prolonged sedentary bouts per day

  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

  Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program

• daily light-intensity physical activity time (h/day)

  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)

  Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program

• daily step count (steps/day)

  Before the SIT LESS Booster program and in week 3 of the SIT LESS Booster program

Study Arms (2)

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.

Behavioral: SIT LESS Booster

Interventions

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

SIT LESS Booster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to give informed consent
• Wheelchair-bounded / not physically able to stand or walk.
• Language barrier
• New York Heart Association class III or IV heart failure
• Participation in another interventional study targeting SB or PA

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 35692440 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.

  PMID: 36788615 BACKGROUND

• 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.

  PMID: 40112182 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Officials

• Thijs MH Eijsvogels, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 14, 2023
• Study Start: August 30, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 28, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: IPD will be availabe after publication of the results by the research team.
• Access Criteria: 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.

Locations

NL (1)