search
Back to results

Effect of Interrupting Sedentary Time With Different Frequencies of Physical Activity on Cardiometabolic Risk Factors

Primary Purpose

Sedentary, Cardiometabolic Syndrome, Physical Activity

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sedentary breaks
Sponsored by
Norwegian School of Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedentary

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Predominantly sedentary occupation. Physical activity: equal or less tham 150 minutes /week Nonobese. Central adiposity: Waist circumference equal or less than 102 cm for men and equal or less than < 88 cm for women. BMI < 30 km·m2 Exclusion Criteria: Shift-work Smoking Pregnancy Current use of medication, except from hormonal contraceptives. No presence of any co-morbidity (e.g. diabetes type 2, cardiovascular or cardiorespiratory disease, or other conditions known to affect carbohydrate and lipid metabolism - thyroid-, -liver or kidney). Systolic /diastolic resting blood pressure: > 140/90 mmHg Fasting blood glucose concentration: > 6.1 mmol/L Abnormal total cholesterol, LDL, LDL or triglyceride concentrations (> 50% above recommendations)

Sites / Locations

  • Norwegian School of Sports Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Control condition

Condition 1

Condition 2

Condition 3

Arm Description

Control condition: Sitting from 8 am until 3pm.

Condition 1: 35 minutes of treadmill walking followed by sitting until hour 7 is reached

Condition 2: 2.5 minutes of treadmill walking for every 30 minutes until hour 7 is reached.

Condition 3: 5 minutes of treadmill walking every 60 minutes, until hour 7 is reached.

Outcomes

Primary Outcome Measures

Incremental areas under the curve (iAUC) for glucose
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition

Secondary Outcome Measures

iAUC analyses for insulin, c-peptide, triglycerides and lipids
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Cognitive function - Trail making test A and B
Cognitive function tasks will be performed, and cognitive function will be assessed by Trail making test A and B,
Cognitive function - Stroop-test.
Cognitive function tasks will be performed, and cognitive function will be assessed by T Stroop-test.

Full Information

First Posted
November 4, 2022
Last Updated
May 26, 2023
Sponsor
Norwegian School of Sport Sciences
Collaborators
The Research Council of Norway
search

1. Study Identification

Unique Protocol Identification Number
NCT05622006
Brief Title
Effect of Interrupting Sedentary Time With Different Frequencies of Physical Activity on Cardiometabolic Risk Factors
Official Title
The Effects of Interrupting Sedentary Behaviour With Different Frequencies of Physical Activity on Cardiometabolic- and Cardiovascular Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian School of Sport Sciences
Collaborators
The Research Council of Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The knowledge gap on sedentary behavior and sedentary breaks includes whether detrimental effects of sedentary behavior can be fully attenuated by 1.) sedentary breaks 2.) physical activity or 3.) both combined. Specifically, when breaking sedentary time which physical activity pattern- and intensity modifies the negative effects of sedentary behavior on glucose- and lipid metabolism? This lack of quantitative evidence calls for prospective experimental studies investigating the physiological and biological impacts of sedentary behavior, as well as the effectiveness of different strategies to reduce sedentary time. Thus, quantifying effects of the intensity, frequency, volume and investigating the patterns of sedentary breaks and/or physical activity on predefined outcomes is of importance. Aims: Our primary aims are to investigate the effects of breaking up sedentary time on glucose- and lipid metabolism and thus examine whether pattern for sedentary bouts and breaks and physical activity intensity during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions: • How does different patterns of accumulation of sedentary bouts and breaks acutely influence glucose- and lipid metabolism under iso-caloric conditions?
Detailed Description
The participants will undergo 4 different trial conditions of which all are iso-caloric, but with different intervals of sitting and executing moderate physical activity by treadmill walking corresponding to 45-55% of their individual VO2max/peak values, estimated from the individual's pre-test. The total duration of sedentary- and physical activity time will be identical in each trial condition. This study has a is randomized cross-over design. If found eligible from step 1 and 2 in the inclusion process, participants will be invited to a final screening day in our lab. Eligible participants then consenting to joining the study will continue on to 4 trial days. Due to possible acute rise in insulin for up to 48 hours, a 5-14 day washout period between trials will be used to avoid carryover effects. In the washout periods between experimental conditions the participants will resume their habitual life activities and behaviours, i.e., diet and physical activity patterns. However, from visit 2, during washout the participants will wear accelerometers (ActiGraph GTX3+, Pensacola, FL) during waking hours to objectively measure sedentary time and physical activity. Average sedentary time (hour/day) and time spent in , light-, moderate- and vigorous physical activity intensity (min/day) will be derived. During the main trial days, the participants may read or work on a personal computer during the sedentary time in the respective trial conditions. The sample size calculations with glucose as the primary outcome, are based on the study by Dunstan et al. (2012). They estimated that 19 paired observations were needed to secure a power of 0.90 in order to detect the smallest expected effect size between the interventions, when using a two-tailed test with a significance level of 5%. To account for the possibility of dropouts the sample size in the present project is set to recruit 30 participants, with 25 participants completing the trials, and thus planning for 80% power

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary, Cardiometabolic Syndrome, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study will be conducted as randomized controlled crossover trials involving 4 different trial conditions in each of the studies. Randomization will be stratified based on sex. The order of trials will be assigned randomly by a third party using a computer software. After pre-testing and familiarization (visit 1), the participants will undergo 4 different trial conditions of 7 hours. The trials are all iso-caloric, but with different intervals of sitting and executing moderate physical activity by treadmill walking corresponding to 60-65% of their individual VO2max values, estimated from the individual's pre-test. The volume of sedentary- and physical activity time will be identical in each trial condition. Blood samples will be taken and blood pressure measured every 30 minutes. The visits for main testing will be separated by a washout period of minimum 5 days, and women will be tested in the follicular phase.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control condition
Arm Type
Experimental
Arm Description
Control condition: Sitting from 8 am until 3pm.
Arm Title
Condition 1
Arm Type
Experimental
Arm Description
Condition 1: 35 minutes of treadmill walking followed by sitting until hour 7 is reached
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
Condition 2: 2.5 minutes of treadmill walking for every 30 minutes until hour 7 is reached.
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
Condition 3: 5 minutes of treadmill walking every 60 minutes, until hour 7 is reached.
Intervention Type
Behavioral
Intervention Name(s)
Sedentary breaks
Intervention Description
Interrupting sitting with different frequencies of walking/jogging at moderate intensity.
Primary Outcome Measure Information:
Title
Incremental areas under the curve (iAUC) for glucose
Description
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Time Frame
The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
Secondary Outcome Measure Information:
Title
iAUC analyses for insulin, c-peptide, triglycerides and lipids
Description
During each of the trial conditions blood samples will be taken in the fasted state in the morning and then every 30 minutes of the trials (total 420minutes) through a peripheral venous catheter. We will then calculate the iAUC for glucose for each of the trial condition and compare the different trial conditions with the control condition
Time Frame
The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
Title
Cognitive function - Trail making test A and B
Description
Cognitive function tasks will be performed, and cognitive function will be assessed by Trail making test A and B,
Time Frame
The cognitive measures will be performed during the procedure (at approx 400 minutes)
Title
Cognitive function - Stroop-test.
Description
Cognitive function tasks will be performed, and cognitive function will be assessed by T Stroop-test.
Time Frame
The cognitive measures will be performed during the procedure (at approx 400 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Predominantly sedentary occupation. Physical activity: equal or less tham 150 minutes /week Nonobese. Central adiposity: Waist circumference equal or less than 102 cm for men and equal or less than < 88 cm for women. BMI < 30 km·m2 Exclusion Criteria: Shift-work Smoking Pregnancy Current use of medication, except from hormonal contraceptives. No presence of any co-morbidity (e.g. diabetes type 2, cardiovascular or cardiorespiratory disease, or other conditions known to affect carbohydrate and lipid metabolism - thyroid-, -liver or kidney). Systolic /diastolic resting blood pressure: > 140/90 mmHg Fasting blood glucose concentration: > 6.1 mmol/L Abnormal total cholesterol, LDL, LDL or triglyceride concentrations (> 50% above recommendations)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jostein Steene-Johannessen, Professor
Organizational Affiliation
Norwegian School of Sport Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian School of Sports Sciences
City
Oslo
ZIP/Postal Code
0806
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Interrupting Sedentary Time With Different Frequencies of Physical Activity on Cardiometabolic Risk Factors

We'll reach out to this number within 24 hrs