Prolonged SittingNCT02215603
Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults
A study testing Breaking prolonged sitting with physical activity in people with Prolonged Sitting and Breaking Prolonged Sitting With Physical Activity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Sitting, Breaking Prolonged Sitting With Physical Activity
- What is being tested?
- Breaking prolonged sitting with physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Dec 2016
- Phase
- Interventional
- 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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males,
- age 25-55 y,
- BMI >18 and <35 kg/m2
Who cannot join
- Clinically diagnosed diabetes,
- dyslipidaemia,
- hypertension,
- use of glucose- and/or lipid-lowering medication,
- smoking,
- evidence of thyroid, liver, lung, heart or kidney disease,
Show all 9Show fewer
- non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the last 4 months,
- VO2max levels above the considered average fitness according to age,
- contraindication to increased levels of physical activity.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Centre of Inflammation and Metabolism
Copenhagen, 2100
Inge Holm
Bente Pedersen, PhD
About this study
Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.
Ten sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.
The investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.
- Being tested
- Breaking prolonged sitting with physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breaking prolonged sitting with physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Prolonged sitting | No intervention | 9 h of prolonged sitting |
| Prolonged sitting + interval standing bouts | Experimental | Stand bout for 15-min every 30 minutes during the 9 hours of sitting Receives: Behavioral: Breaking prolonged sitting with physical activity |
| Moderate exercise bout + Prolonged sitting | Experimental | 30-min moderate-intensity exercise bout followed by 8 h of sitting Receives: Behavioral: Breaking prolonged sitting with physical activity |
| Moderate exercise bout + Prolonged sitting +Standing bouts | Experimental | 30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting Receives: Behavioral: Breaking prolonged sitting with physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of glucose and insulin postprandial responses
Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
Measured: 27 h
Secondary outcomes (2)
Glucose levels
Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours. Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).
Measured: 27 hours
Area under the curve of lipid postprandial responses
Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
Measured: 27 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged SittingStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215603
- Sponsor's protocol ID
- ProlongedSitting
- Status last verified
- Jan 2016
- First submitted
- 7 Aug 2014
- Last updated
- 13 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults
- ClinicalTrials.gov ID
- NCT02215603
- Acronym / sponsor ID
- ProlongedSitting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Aug 2014 (estimated)
- 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.
Great controversy exists with respect to the optimal or the minimum volume, intensity, and frequency of physical activity capable of attenuating the hazards of prolonged sitting on the metabolic profile. Thus, our study aims to comprehensively investigate the effects of disrupting prolonged sitting with different physical activity protocols on metabolic risk factors in sedentary males.
Ten sedentary males will take part in this randomized cross-over trial consisting of four 27-h conditions. All conditions will be identical except for the physical activity: prolonged sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged sitting+interval standing intervention (STAND), participants will stand for 15 min every 30 minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will sit for the remaining time; and prolonged sitting+moderate-intensity exercise bout +interval standing intervention (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and cytokines will be determined.
The investigators expect that disrupting prolonged sitting with intermittent standing and a moderate-exercise bout will positively affect the metabolic profile of the participants. Furthermore, we will investigate if combined, these strategies will have an additive effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prolonged sitting | No intervention | –9 h of prolonged sitting |
| Prolonged sitting + interval standing bouts | Experimental | Behavioral: Breaking prolonged sitting with physical activityStand bout for 15-min every 30 minutes during the 9 hours of sitting |
| Moderate exercise bout + Prolonged sitting | Experimental | Behavioral: Breaking prolonged sitting with physical activity30-min moderate-intensity exercise bout followed by 8 h of sitting |
| Moderate exercise bout + Prolonged sitting +Standing bouts | Experimental | Behavioral: Breaking prolonged sitting with physical activity30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males,
- age 25-55 y,
- BMI >18 and <35 kg/m2
Key exclusion criteria (9 listed)
- Clinically diagnosed diabetes,
- dyslipidaemia,
- hypertension,
- use of glucose- and/or lipid-lowering medication,
- smoking,
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 |
|---|---|---|
| Breaking prolonged sitting with physical activity | Behavioural | Moderate exercise bout + Prolonged sitting, Moderate exercise bout + Prolonged sitting +Standing bouts, Prolonged sitting + interval standing bouts |
Primary outcome
Area under the curve of glucose and insulin postprandial responses
Time frame: 27 h
Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
2 secondary outcomes
Glucose levels
Time frame: 27 hours
Area under the curve of lipid postprandial responses
Time frame: 27 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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Frequency of Interrupting Sitting and Cognitive Function
Sedentary Behaviors, Breaking Prolonged Sitting With Physical Activity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breaking prolonged sitting with physical activity in people with Prolonged Sitting and Breaking Prolonged Sitting With Physical Activity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Jan 2016. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabiana Benatti (+45 35450898, fabiana.braga.benatti@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of glucose and insulin postprandial responses (time frame: 27 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2016; AzTrials last refreshed its copy on 3 Nov 2026.