NCT02215603

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

August 7, 2014

Last Update Submit

January 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    27 h

Secondary Outcomes (2)

  • Glucose levels

    27 hours

  • Area under the curve of lipid postprandial responses

    27 h

Other Outcomes (1)

  • Area under the curve of cytokine postprandial responses

    27 h

Study Arms (4)

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

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

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

Behavioral: Breaking prolonged sitting with physical activity

Interventions

Moderate exercise bout + Prolonged sittingModerate exercise bout + Prolonged sitting +Standing boutsProlonged sitting + interval standing bouts

Eligibility Criteria

Age25 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Inflammation and Metabolism

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 13, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations