NCT04711928

Brief Summary

Physical inactivity is one of the major contributing factors for the development of chronic diseases and highly correlated with increased all-cause mortality. In the last decade an exponential growth in research concerned with the study of sedentary behaviour and the potential for detrimental effects on health have been published. In this field increasing evidence suggests that prolonged periods of sedentary time, independent of the amount of physical activity, also increases the risk for the development of several chronic conditions and all-cause mortality. Here, sedentary behaviour is defined as "any waking behaviour, characterized by a low energy expenditure (≤1.5 METs), while being in a sitting or reclining posture". Interestingly, the advised moderate-to-vigorous bouts of exercise recommended by the various guidelines cannot compensate the negative impact on health risks arising from prolonged periods of sitting. In other words, it seems that people compensate their total amount of physical activity after exercise training by decreasing their physical activity levels throughout the rest of the day. Here, it appears that frequent, even low-intensity interruptions of periods of sitting are required for good cardiometabolic health. Therefore, not only physical activity but also prolonged sitting should be targeted to optimize cardiometabolic health. Nevertheless, a recent harmonized meta-syntheses indicated that the association between self-reported sitting with all-cause and cardiovascular disease mortality are only partially independent of physical activity, but were particularly evident in those who undertake insufficient physical activity (\<150min/week). However, it is unclear whether high amounts of objectively measured physical activity attenuates or even eliminates the detrimental effects of prolonged sitting. In addition, it is still unclear whether high amounts of physical activity can preserve a healthy cardiometabolic risk profile, despite prolonged sitting. Therefore, in this study we want to investigate the association between sedentary behaviour, physical activity and cardiometabolic health in highly physically active adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

January 13, 2021

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sedentary time (min/day)

    Main outcome parameter of sedentary behaviour indication measured with ActivPAL3

    day 1

Secondary Outcomes (13)

  • Moderate-to-vigorous physical activity time (min/day)

    day 1

  • Light physical activity time (min/day)

    day 1

  • Blood glucose concentration

    day 1

  • Blood insulin concentration

    day1

  • Blood total cholesterol concentration

    day 1

  • +8 more secondary outcomes

Study Arms (1)

Trained athletes

Active individuals with at least 4 training hours per week.

Behavioral: Physical activity and sedentary behaviour

Interventions

Athletes with a high physical activity and a low or high sedentary time

Trained athletes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Active individuals with at least 4 training hours per week and between 18 and 45 years of age.

You may qualify if:

  • Active individuals with at least 4 training hours per week

You may not qualify if:

  • pregnancy
  • Any known contradiction for physical activity
  • Systolic blood pressure \>160mmHg, diastolic blood pressure \>100mmHg
  • More than 20 alcohol consumptions per week
  • Participants diagnosed with any known chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wouter Franssen

Diepenbeek, Limburg, 3590, Belgium

Location

Related Publications (1)

  • Franssen WMA, Jermei J, Savelberg HHCM, Eijnde BO. The potential harms of sedentary behaviour on cardiometabolic health are mitigated in highly active adults: a compositional data analysis. J Act Sedentary Sleep Behav. 2023 Mar 2;2(1):6. doi: 10.1186/s44167-023-00015-7.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

January 10, 2021

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations