Cardiometabolic HealthHPACNCT04711928
The Association Between Sedentary Behaviour and Cardiometabolic Health in Trained Athletes
An observational study of Cardiometabolic Health and Sedentary Behavior, run by Hasselt University at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cardiometabolic Health, Sedentary Behavior, Physical Activity
- What is being tested?
- Physical activity and sedentary behaviour
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Jan 2021to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
Study population: Active individuals with at least 4 training hours per week and between 18 and 45 years of age.
Who may be able to join
- Active individuals with at least 4 training hours per week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Physical activity and sedentary behaviour
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and sedentary behaviourBehavioural
Athletes with a high physical activity and a low or high sedentary time
| Study group | Role | What they receive |
|---|---|---|
| Trained athletes | Active individuals with at least 4 training hours per week. Receives: Behavioral: Physical activity and sedentary behaviour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary time (min/day)
Main outcome parameter of sedentary behaviour indication measured with ActivPAL3
Measured: day 1
Secondary outcomes (13)
Moderate-to-vigorous physical activity time (min/day)
Physical activity parameter measured with ActivPAL3
Measured: day 1
Light physical activity time (min/day)
Physical activity parameter measured with ActivPAL3
Measured: day 1
Blood glucose concentration
Parameter of glucose homeostatis
Measured: day 1
Blood insulin concentration
Parameter of glucose homeostatis
Measured: day1
Blood total cholesterol concentration
Parameter of lipid metabolism
Measured: day 1
Blood triglyceride concentration
Parameter of lipid metabolism
Measured: day 1
Blood high density lipoprotein concentration
Parameter of lipid metabolism
Measured: day 1
Blood low density lipoprotein concentration
Parameter of lipid metabolism
Measured: day 1
Fat mass (kg)
Parameter of body composition measured with DEXA-scan
Measured: day 1
Lean mass (kg)
Parameter of body composition measured with DEXA-scan
Measured: day 1
Systolic blood pressure
Parameter of cardiovascular health
Measured: day 1
Diastolic blood pressure
Parameter of cardiovascular health
Measured: day 1
Maximal oxygen uptake
Parameter of oxygen capacity measured with cardiopulmonary exercise testing
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start10 Jan 2021
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bert Op't Eijnde, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711928
- Sponsor's protocol ID
- CME2020/012
- Acronym
- HPAC
- Status last verified
- Mar 2022
- First submitted
- 13 Jan 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40217441
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Trained Athletes Also Suffer From the Sedentary Behaviour Paradigm?: the Association Between Sedentary Behaviour and Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT04711928
- Acronym / sponsor ID
- HPAC / CME2020/012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trained athletes | – | Behavioral: Physical activity and sedentary behaviourActive individuals with at least 4 training hours per week. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Active individuals with at least 4 training hours per week and between 18 and 45 years of age.
Key inclusion criteria (1 listed)
- Active individuals with at least 4 training hours per week
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity and sedentary behaviourAthletes with a high physical activity and a low or high sedentary time | Behavioural | Trained athletes |
Primary outcome
Sedentary time (min/day)
Time frame: day 1
Main outcome parameter of sedentary behaviour indication measured with ActivPAL3
13 secondary outcomes
Moderate-to-vigorous physical activity time (min/day)
Time frame: day 1
Light physical activity time (min/day)
Time frame: day 1
Blood glucose concentration
Time frame: day 1
Blood insulin concentration
Time frame: day1
Blood total cholesterol concentration
Time frame: day 1
Blood triglyceride concentration
Time frame: day 1
Blood high density lipoprotein concentration
Time frame: day 1
Blood low density lipoprotein concentration
Time frame: day 1
Fat mass (kg)
Time frame: day 1
Lean mass (kg)
Time frame: day 1
Systolic blood pressure
Time frame: day 1
Diastolic blood pressure
Time frame: day 1
Maximal oxygen uptake
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 40217441Franssen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Health and Sedentary Behavior, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary time (min/day) (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04711928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.