Effects of Interrupting Sedentary Behavior With High - or Low Intensity PA on CVD - and Cardiometabolic Riskfactors, and Cognitive Performance.

Physical Activity Clinical Trial

Official title:

Effects of Interrupting Sedentary Behavior With High - or Low Intensity Physical Activity on Cardiovascular - and Cardiometabolic Riskfactors, and Cognitive Performance.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05709379
• Other study ID #: GENSED#2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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?

Description:

The participants will undergo 3 different trial conditions of which all are iso-caloric, but with different intensities when executing physical activity (PA) by treadmill walking corresponding to 25-30% or 80-85%, respectively, of their individual VO2max/peak values. PA intensities are estimated from the individual's pre-test. The trial-conditions are iso-caloric, and tailored to each individual's energy expenditure. 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 3 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 behaviors, 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 for 7 consecutive days after each trial. 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: August 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Physical Activity
• Sedentary Behavior

Intervention

Behavioral:
• Sedentary behavior
Interrupting sitting with walking/jogging at either high -or low physical activity intensity.

Locations

Country	Name	City	State
Norway	Norwegian School of Sports Sciences	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total (tAUC)- and 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	The iAUC for glucose will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
Secondary	tAUC and iAUC analyses for insulin	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)
Secondary	tAUC and iAUC analyses for c-peptide	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)
Secondary	tAUC and iAUC analyses for triglycerides	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)
Secondary	tAUC and iAUC analyses for 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	The iAUC for the secondary outcomes will be assessed during the procedure and consist of measures every 30 minute throughout the trial (420 minutes)
Secondary	Cognitive function and performance	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)