The Association Between Sedentary Behaviour and Cardiometabolic Health in Trained Athletes (HPAC)

March 14, 2022 updated by: Bert Op't Eijnde, Hasselt University

Do Trained Athletes Also Suffer From the Sedentary Behaviour Paradigm?: the Association Between Sedentary Behaviour and Cardiometabolic Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Diepenbeek, Limburg, Belgium, 3590
        • Wouter Franssen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Active individuals with at least 4 training hours per week

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Trained athletes
Active individuals with at least 4 training hours per week.
Behavioral: Physical activity and sedentary behaviour
Athletes with a high physical activity and a low or high sedentary time

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sedentary time (min/day)
Time Frame: day 1
Main outcome parameter of sedentary behaviour indication measured with ActivPAL3
day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Moderate-to-vigorous physical activity time (min/day)
Time Frame: day 1
Physical activity parameter measured with ActivPAL3
day 1
Light physical activity time (min/day)
Time Frame: day 1
Physical activity parameter measured with ActivPAL3
day 1
Blood glucose concentration
Time Frame: day 1
Parameter of glucose homeostatis
day 1
Blood insulin concentration
Time Frame: day1
Parameter of glucose homeostatis
day1
Blood total cholesterol concentration
Time Frame: day 1
Parameter of lipid metabolism
day 1
Blood triglyceride concentration
Time Frame: day 1
Parameter of lipid metabolism
day 1
Blood high density lipoprotein concentration
Time Frame: day 1
Parameter of lipid metabolism
day 1
Blood low density lipoprotein concentration
Time Frame: day 1
Parameter of lipid metabolism
day 1
Fat mass (kg)
Time Frame: day 1
Parameter of body composition measured with DEXA-scan
day 1
Lean mass (kg)
Time Frame: day 1
Parameter of body composition measured with DEXA-scan
day 1
Systolic blood pressure
Time Frame: day 1
Parameter of cardiovascular health
day 1
Diastolic blood pressure
Time Frame: day 1
Parameter of cardiovascular health
day 1
Maximal oxygen uptake
Time Frame: day 1
Parameter of oxygen capacity measured with cardiopulmonary exercise testing
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CME2020/012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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