Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity

NCT06270810 | Completed

• 1 other identifier: Aero-PA
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables. The main question it aims to answer is: • Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women? To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables.

Conditions

Overweight

Keywords

Overweight; non-Exercise Physical Activity; Aerobic Exercise; Sedentary Behaviour; Physical Activity; Step Counts; Cardiometabolic; Blood Lipids; Serum Glucose; HbA1c; Blood Pressure; Young Women; Cardiorespiratory Fitness

Outcome Measures

Primary Outcomes (8)

• Low Density Lipoprotein (LDL) Cholesterol

  Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• High Density Lipoprotein (HDL) Cholesterol

  Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Total Cholesterol

  Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Glycated Hemoglobin (HbA1C)

  Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Serum Triglycerides

  Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Maximal Oxygen Consumption

  Maximal oxygen consumption will be estimated by the Rockport 1 Mile Walk Test

  The week before the beginning of the interventions, and the week after the interventions

• Systolic Blood Pressure

  Measurements will be made on the arm with a digital blood pressure monitor after resting for at least 10 minutes in a supine position to ensure hemodynamic stability. By wrapping the cuff around the arm, brachial systolic blood pressure will be automatically measured.

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Diastolic Blood Pressure

  Measurements will be made on the arm with a digital blood pressure monitor after resting for at least 10 minutes in a supine position to ensure hemodynamic stability. By wrapping the cuff around the arm, brachial diastolic blood pressure will be automatically measured.

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

Secondary Outcomes (4)

• Body Fat Percentage

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Fat-free Mass

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Waist Circumference

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

• Hip Circumference

  The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

Study Arms (2)

Aerobic Exercise (AeroEx) Group

EXPERIMENTAL

Participants in this group will do moderate-intensity aerobic training for 4 days a week for 8 weeks.

Behavioral: Aerobic Exercise

Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) Group

EXPERIMENTAL

Participants in this group will increase their non-exercise physical activities and do moderate-intensity aerobic training for four days a week for 8 weeks.

Behavioral: Aerobic Exercise; Behavioral: Increasing non-Exercise Physical Activity

Interventions

Aerobic Exercise BEHAVIORAL

Aerobic exercise will be performed on the treadmill at 40-60% of the participants' heart rate reserves. Each aerobic exercise session will last for 40 minutes. All participants will be monitored with a heart rate monitor throughout the exercise sessions. During the first three-week, participants will exercise on the treadmill at intensities between 40-50%, and between fourth and eighth weeks, 50-60% of their heart rate reserves. Participants will wear an accelerometer on their non-dominant wrist during the intervention to monitor the physical activity and sedentary behavior data. At the same time, these participants will be asked not to change their routine diet during the intervention period.

Aerobic Exercise (AeroEx) Group; Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) Group

Increasing non-Exercise Physical Activity BEHAVIORAL

Participants who will carry out this intervention will increase their non-exercise physical activities. Before intervention period, participants will receive face-to-face training to increase their non-exercise physical activities. This training will generally consist of recommendations based on the study which effectively reduced sedentary behavior (SB) with non-exercise physical activities (Sarah Kozey-Keadle et al. 2012). A one-on-one interview will be held with each participant every week to learn about strategies by which the volunteers successfully increased their non-exercise physical activities in the previous week, and the difficulties or barriers they encountered. New strategies to overcome these difficulties and barriers will be discussed and suggestions will be made. Participants will wear an accelerometer on their non-dominant wrist to monitor the physical activity and SB data, and will be asked not to change their routine diet during the intervention period.

Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To have a body mass index between 25 kg.(m2)-1 and 29.9 kg.(m2)-1
• Self reported sitting time greater than 7 hours per day
• Not exercising regularly in the last 3 months

You may not qualify if:

• Hypertension
• Coronary heart disease
• Heart failure
• Diabetes mellitus (A1C being 6.5% and above)
• Prediabetes (A1C between 5.7% and 6.4%)
• Metabolic syndrome
• Hypothyroidism
• Non-alcoholic fatty liver disease
• Chronic inflammatory disease
• Chronic renal failure
• Cushing's syndrome
• Musculoskeletal disorder that will affect the ability to do physical activity
• HIV infection
• Being on antihypertensive medication
• Being on lipid-lowering medication

Sponsors & Collaborators

• Kastamonu University: lead

Study Sites (1)

Kastamonu University, Çatalzeytin Vocational School

Çatalzeytin, Kastamonu, 37, Turkey (Türkiye)

Location

Related Publications (2)

• Kozey-Keadle S, Libertine A, Staudenmayer J, Freedson P. The Feasibility of Reducing and Measuring Sedentary Time among Overweight, Non-Exercising Office Workers. J Obes. 2012;2012:282303. doi: 10.1155/2012/282303. Epub 2011 Nov 16.

  PMID: 22175004 BACKGROUND

• Kozey Keadle S, Lyden K, Staudenmayer J, Hickey A, Viskochil R, Braun B, Freedson PS. The independent and combined effects of exercise training and reducing sedentary behavior on cardiometabolic risk factors. Appl Physiol Nutr Metab. 2014 Jul;39(7):770-80. doi: 10.1139/apnm-2013-0379. Epub 2014 Jan 7.

  PMID: 24971677 BACKGROUND

MeSH Terms

Conditions

Overweight; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: March 11, 2024
• Primary Completion: June 18, 2025
• Study Completion: September 1, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

TU (1)