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Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults

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ClinicalTrials.gov Identifier: NCT02215603
Recruitment Status : Unknown
Verified January 2016 by Anders Rasmussen Rinnov, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Anders Rasmussen Rinnov, Rigshospitalet, Denmark

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Prolonged Sitting Breaking Prolonged Sitting With Physical Activity Behavioral: Breaking prolonged sitting with physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Prolonged sitting
9 h of prolonged sitting
Experimental: Prolonged sitting + interval standing bouts
Stand bout for 15-min every 30 minutes during the 9 hours of sitting
Behavioral: Breaking prolonged sitting with physical activity
Experimental: Moderate exercise bout + Prolonged sitting
30-min moderate-intensity exercise bout followed by 8 h of sitting
Behavioral: Breaking prolonged sitting with physical activity
Experimental: Moderate exercise bout + Prolonged sitting +Standing bouts
30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting
Behavioral: Breaking prolonged sitting with physical activity



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Glucose levels [ Time Frame: 27 hours ]
    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).

  2. Area under the curve of lipid postprandial responses [ Time Frame: 27 h ]
    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).


Other Outcome Measures:
  1. Area under the curve of cytokine postprandial responses [ Time Frame: 27 h ]
    Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) 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).



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males,
  • age 25-55 y,
  • BMI >18 and <35 kg/m2

Exclusion Criteria:

  • Clinically diagnosed diabetes,
  • dyslipidaemia,
  • hypertension,
  • use of glucose- and/or lipid-lowering medication,
  • smoking,
  • evidence of thyroid, liver, lung, heart or kidney disease,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215603


Contacts
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Contact: Fabiana Benatti +45 35450898 fabiana.braga.benatti@regionh.dk

Locations
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Denmark
Centre of Inflammation and Metabolism Recruiting
Copenhagen, Denmark, 2100
Contact: Inge Holm         
Principal Investigator: Bente Pedersen, PhD         
Sub-Investigator: Fabiana Benatti, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

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Responsible Party: Anders Rasmussen Rinnov, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02215603     History of Changes
Other Study ID Numbers: ProlongedSitting
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016