- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05709379
Effects of Interrupting Sedentary Behavior With High - or Low Intensity PA on CVD - and Cardiometabolic Riskfactors, and Cognitive Performance.
Effects of Interrupting Sedentary Behavior With High - or Low Intensity Physical Activity on Cardiovascular - and Cardiometabolic Riskfactors, and Cognitive Performance.
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 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 physical activity intensity breaks during sedentary breaks matter. Specifically, the aims of the PhD-project are to provide knowledge on the following questions:
• How does high- or low physical activity intensity sedentary breaks acutely influence glucose- and lipid metabolism under iso-caloric conditions?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oslo County
-
Oslo, Oslo County, Norway, 0806
- Norwegian School of Sports Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control trial
Sitting from 8 am until 3pm.
|
Interrupting sitting with walking/jogging at either high -or low physical activity intensity.
|
|
Experimental: High intensity sedentary breaks
Physical activity on 80-85% of individual VO2max every hour.
Modality: Hill walking/jogging on treadmill.
|
Interrupting sitting with walking/jogging at either high -or low physical activity intensity.
|
|
Experimental: Low intensity sedentary breaks
Physical activity on 25-30% of individual VO2max every hour.
Modality: Hill walking on treadmill.
|
Interrupting sitting with walking/jogging at either high -or low physical activity intensity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total (tAUC)- and incremental areas under the curve (iAUC) for glucose
Time Frame: The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
|
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
|
The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tAUC and iAUC analyses for insulin
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)
|
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
|
The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
|
|
tAUC and iAUC analyses for c-peptide
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)
|
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
|
The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
|
|
tAUC and iAUC analyses for triglycerides
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)
|
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
|
The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
|
|
tAUC and iAUC analyses for lipids
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)
|
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
|
The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
|
|
Cognitive function and performance
Time Frame: The cognitive measures will be performed during the procedure (at approx 400 minutes)
|
Cognitive function tasks will be performed, and cognitive function will be assessed by Trail making test A and B, and Stroop-test.
|
The cognitive measures will be performed during the procedure (at approx 400 minutes)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jostein Steene-Johennessen, Professor, Norwegian School of Sports Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GENSED#2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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