- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06106464
Cardiometabolic Effects of Aerobic Exercise Plus Breaking Sitting
Acute Cardiometabolic Effects of Moderate-Intensity Aerobic Exercise Plus Interrupting Sitting With Different Frequencies of Low-Intensity Physical Activity-A Randomized Crossover Trial
The goal of this randomized crossover clinical trial is to investigate the effects of interrupting prolonged sitting with intermittent walks of equal volume but at different frequencies, in addition to moderate-intensity aerobic exercise, on postprandial serum lipid profile in young adults between the ages of 18-30. The main questions it aims to answer are:
- Do interrupting prolonged sitting with intermittent walks of equal volume but at different frequencies sustain positive cardiometabolic effects after moderate-intensity aerobic exercise?
- If "yes", which frequency of breaks is more effective to provide cardiometabolic benefits?
Participants will complete four conditions on separate days: 1) 6.5 hours of prolonged sitting after 30 minutes of moderate intensity aerobic exercise 2) breaking prolonged sitting with 2 minutes of walking every 30 minutes after 30 minutes of moderate intensity exercise 3) breaking prolonged sitting with 4 minutes of walking every 1-h after 30 minutes of moderate intensity exercise 4) breaking prolonged sitting with 8 minutes of walking every 2-h after 30 minutes of moderate intensity aerobic exercise.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kastamonu, Turkey, 37
- Kastamonu University, Çatalzeytin Vocational School
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between the ages of 18-30
- Being able to participate in physical activity
- More than 7 hours of daily sitting time measured subjectively
- Not exercising regularly in the last 3 months
Exclusion Criteria:
- Hypertension
- Coronary heart disease
- Heart failure
- Diabetes mellitus
- Metabolic syndrome
- Obesity
- Hypothyroidism
- Non-alcoholic fatty liver disease
- Chronic inflammatory joint disease
- Chronic renal failure
- Cushing's syndrome
- HIV infection
- Being on antihypertensive medication
- Being on lipid-lowering medication
- Being on antidiabetic medication
- Being on systemic glucocorticoid medication
- LDL-cholesterol≥130 mg.dL-1
- HDL-cholesterol <40 mg.dL-1 for men; <50 mg.dL-1 for women
- Prediabetes
- Alcohol addiction
- Smoking
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic exercise+6.5 h of prolonged sitting
Participants will sit 6.5 hours after 30 minutes of moderate intensity aerobic exercise.
|
Volunteers, whose fasting blood samples are drawn and who eat a standard breakfast, will perform a 30-minute walking exercise on a treadmill at 40-45% of their heart rate reserve.
They will then sit in the chair for 6.5 hours.
While seated, volunteers will be asked not to leave their seats except to use the toilet.
Volunteers will be able to read and use computers and phones while sitting.
Venous and capillary blood samples will be drawn at regular intervals and their blood pressures will be measured.
|
|
Experimental: Aerobic exercise+2 minutes of walking breaks every 30 minutes
Participants will break prolonged sitting with 2 minutes of walking every 30 minutes after 30 minutes of moderate intensity aerobic exercise.
|
Volunteers, whose fasting blood samples are drawn and who eat a standard breakfast, will perform a 30-minute walking exercise on a treadmill at 40-45% of their heart rate reserve.
They will then interrupt sitting with 2-minute walks at 35-40% of their heart rate reserve every 30 minutes for 6.5 hours after moderate-intensity aerobic exercise.
They will make a twelve interruptions throughout 6.5 hours period and will have a total of 24 minutes of interruption throughout the intervention.
While seated, volunteers will be asked not to leave their seats except to use the toilet.
Volunteers will be able to read and use computers and phones while sitting.
Venous and capillary blood samples will be drawn at regular intervals and their blood pressures will be measured.
|
|
Experimental: Aerobic exercise+4 minutes of walking breaks every 1-h
Participants will break prolonged sitting with 4 minutes of walking every 1-h after 30 minutes of moderate intensity aerobic exercise.
|
Volunteers, whose fasting blood samples are drawn and who eat a standard breakfast, will perform a 30-minute walking exercise on a treadmill at 40-45% of their heart rate reserve.
They will then interrupt sitting with 4-minute walks at 35-40% of their heart rate reserve every 1 hour for 6.5 hours after moderate-intensity aerobic exercise.
They will make six interruptions throughout 6.5 hours period and will have a total of 24 minutes of interruption throughout the intervention.
While seated, volunteers will be asked not to leave their seats except to use the toilet.
Volunteers will be able to read and use computers and phones while sitting.
Venous and capillary blood samples will be drawn at regular intervals and their blood pressures will be measured.
|
|
Experimental: Aerobic exercise+8 minutes of walking breaks every 2-h
Participants will break prolonged sitting with 8 minutes of walking every 2-h after 30 minutes of moderate intensity aerobic exercise.
|
Volunteers, whose fasting blood samples are drawn and who eat a standard breakfast, will perform a 30-minute walking exercise on a treadmill at 40-45% of their heart rate reserve.
They will then interrupt sitting with 8-minute walks at 35-40% of their heart rate reserve every 2 hour for 6.5 hours after moderate-intensity aerobic exercise.
They will make six interruptions throughout 6.5 hours period and will have a total of 24 minutes of interruption throughout the intervention.
While seated, volunteers will be asked not to leave their seats except to use the toilet.
Volunteers will be able to read and use computers and phones while sitting.
Venous and capillary blood samples will be drawn at regular intervals and their blood pressures will be measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capillary glucose area under the curve
Time Frame: During the four 7.5-hour intervention sessions samples will be collected at the 30th, 60th, 90th, 120th and 210th minutes after breakfast, and at the 30th, 60th, 90th, 120th and 210th minutes after lunch.
|
Fasting and subsequent capillary blood glucose measurements will be carried out.
Blood samples will be taken by pricking the tip of the distal phalanx of the right or left middle finger with a lancet.
The first drop of blood will be wiped with cotton and the second drop of blood will be analyzed with a glucometer (GL 44, Beurer GmbH, Germany).
Two consecutive measurements will be made and the average of both measurements will be recorded.
For each 7.5-hour intervention, the total area under the curve (AUC) will be calculated for capillary glucose using the trapezoidal method.
Incremental AUC will then be calculated by subtracting the area of baseline level from the total AUC.
|
During the four 7.5-hour intervention sessions samples will be collected at the 30th, 60th, 90th, 120th and 210th minutes after breakfast, and at the 30th, 60th, 90th, 120th and 210th minutes after lunch.
|
|
Serum Low-Density Lipoprotein cholesterol area under the curve
Time Frame: During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
Fasting venous blood samples for serum LDL cholesterol will be collected by inserting a cannula into the appropriate vein.
The intravenous cannula will be fixed tightly with patch tape.
Then fasting blood samples will be drawn.
During each 7.5-hour intervention, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch from the intravenous cannula with a syringe.
The blood samples taken into the syringe will be transferred to a yellow capped gel tube and the blood samples will be sent to the biochemistry laboratory for analysis.For each 7.5-hour intervention, the total AUC will be calculated for serum LDL cholesterol using the trapezoidal method.
Incremental AUC will then be calculated by subtracting the area of baseline level from the total AUC.
|
During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
|
Serum High-Density Lipoprotein cholesterol area under the curve
Time Frame: During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
Fasting venous blood samples for serum HDL cholesterol will be collected by inserting a cannula into the appropriate vein.
The intravenous cannula will be fixed tightly with patch tape.
Then fasting blood samples will be drawn.
During each 7.5-hour intervention, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch from the intravenous cannula with a syringe.
The blood samples taken into the syringe will be transferred to a yellow capped gel tube and the blood samples will be sent to the biochemistry laboratory for analysis.For each 7.5-hour intervention, the total AUC will be calculated for serum HDL cholesterol using the trapezoidal method.
Incremental AUC will then be calculated by subtracting the area of baseline level from the total AUC.
|
During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
|
Serum total cholesterol area under the curve
Time Frame: During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
Fasting venous blood samples for serum total cholesterol will be collected by inserting a cannula into the appropriate vein.
The intravenous cannula will be fixed tightly with patch tape.
Then fasting blood samples will be drawn.
During each 7.5-hour intervention, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch from the intravenous cannula with a syringe.
The blood samples taken into the syringe will be transferred to a yellow capped gel tube and the blood samples will be sent to the biochemistry laboratory for analysis.For each 7.5-hour intervention, the total AUC will be calculated for serum total cholesterol using the trapezoidal method.
Incremental AUC will then be calculated by subtracting the area of baseline level from the total AUC.
|
During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
|
Serum triglycerides area under the curve
Time Frame: During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
Fasting venous blood samples for serum triglycerides will be collected by inserting a cannula into the appropriate vein.
The intravenous cannula will be fixed tightly with patch tape.
Then fasting blood samples will be drawn.
During each 7.5-hour intervention, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch from the intravenous cannula with a syringe.
The blood samples taken into the syringe will be transferred to a yellow capped gel tube and the blood samples will be sent to the biochemistry laboratory for analysis.For each 7.5-hour intervention, the total AUC will be calculated for serum triglycerides using the trapezoidal method.
Incremental AUC will then be calculated by subtracting the area of baseline level from the total AUC.
|
During the four 7.5-hour intervention sessions, 5 mL blood samples will be drawn at the 60th, 120th and 210th minutes after breakfast and at the 60th, 120th and 210th minutes after lunch
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic blood pressure
Time Frame: During the four 7.5-hour intervention sessions, measurements will be carried out approximately at the 20th minute of each hour (10:20, 11:20, 12:20, 13:20, 14:20, 15:20, 16:20)
|
Systolic blood pressures will be measured in the arm in the morning before each intervention and at regular intervals during each intervention.
Measurements will be taken in an upright position just before blood samples are taken and after a rest period of at least 10 minutes from the last exercise bout.
Blood pressure measurements will be taken with a digital blood pressure monitor (BM 40, Beurer GmbH, Germany) in the arm.
The first measurement will be taken at approximately 08:30 a.m and the next 7 measurements will be carried out approximately at the 20th minute of each hour (10:20, 11:20, 12:20, 13:20, 14:20, 15:20, 16:20).
Three measurements will be made at one-minute intervals and the average value of the three measurements will be recorded.
|
During the four 7.5-hour intervention sessions, measurements will be carried out approximately at the 20th minute of each hour (10:20, 11:20, 12:20, 13:20, 14:20, 15:20, 16:20)
|
|
Diastolic blood pressure
Time Frame: During the four 7.5-hour intervention sessions, measurements will be carried out approximately at the 20th minute of each hour (10:20, 11:20, 12:20, 13:20, 14:20, 15:20, 16:20)
|
Diastolic blood pressures will be measured in the arm in the morning before each intervention and at regular intervals during each intervention.
Measurements will be taken in an upright position just before blood samples are taken and after a rest period of at least 10 minutes from the last exercise bout.
Blood pressure measurements will be taken with a digital blood pressure monitor (BM 40, Beurer GmbH, Germany) in the arm.
The first measurement will be taken at approximately 08:30 a.m and the next 7 measurements will be carried out approximately at the 20th minute of each hour (10:20, 11:20, 12:20, 13:20, 14:20, 15:20, 16:20).
Three measurements will be made at one-minute intervals and the average value of the three measurements will be recorded.
|
During the four 7.5-hour intervention sessions, measurements will be carried out approximately at the 20th minute of each hour (10:20, 11:20, 12:20, 13:20, 14:20, 15:20, 16:20)
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- LIPA Break
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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