NCT06106464

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

October 24, 2023

Last Update Submit

February 9, 2024

Conditions

Keywords

sedentary breakprolonged sittingblood lipidsblood pressureaerobic exercisewalking

Outcome Measures

Primary Outcomes (5)

  • Capillary glucose area under the curve

    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

    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

    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

    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

    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 Outcomes (2)

  • Systolic blood pressure

    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

    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)

Study Arms (4)

Aerobic exercise+6.5 h of prolonged sitting

EXPERIMENTAL

Participants will sit 6.5 hours after 30 minutes of moderate intensity aerobic exercise.

Other: Aerobic exercise+6.5 h of prolonged sitting

Aerobic exercise+2 minutes of walking breaks every 30 minutes

EXPERIMENTAL

Participants will break prolonged sitting with 2 minutes of walking every 30 minutes after 30 minutes of moderate intensity aerobic exercise.

Other: Aerobic exercise+2 minutes of walking breaks every 30 minutes

Aerobic exercise+4 minutes of walking breaks every 1-h

EXPERIMENTAL

Participants will break prolonged sitting with 4 minutes of walking every 1-h after 30 minutes of moderate intensity aerobic exercise.

Other: Aerobic exercise+4 minutes of walking breaks every 1-h

Aerobic exercise+8 minutes of walking breaks every 2-h

EXPERIMENTAL

Participants will break prolonged sitting with 8 minutes of walking every 2-h after 30 minutes of moderate intensity aerobic exercise.

Other: Aerobic exercise+8 minutes of walking breaks every 2-h

Interventions

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.

Aerobic exercise+6.5 h of prolonged sitting

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.

Aerobic exercise+2 minutes of walking breaks every 30 minutes

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.

Aerobic exercise+4 minutes of walking breaks every 1-h

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.

Aerobic exercise+8 minutes of walking breaks every 2-h

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu University, Çatalzeytin Vocational School

Kastamonu, 37, Turkey (Türkiye)

Location

Related Publications (1)

  • Ak Y, Guzel Y, Akyel S, Tatar OD, Karabulut E, Karaca A. Hourly 4-minute walking breaks from sitting following aerobic exercise reduce postprandial non-HDL cholesterol in healthy young adults: A randomized crossover trial. J Clin Lipidol. 2025 May-Jun;19(3):638-648. doi: 10.1016/j.jacl.2025.03.007. Epub 2025 Mar 21.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

June 12, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations