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

Not Applicable
Active, not recruiting
Conditions
Overweight
Interventions
Behavioral: Aerobic Exercise
Behavioral: Increasing non-Exercise Physical Activity
Registration Number
NCT06270810
Lead Sponsor
Kastamonu University
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.

Detailed Description

According to objective and subjective measurements, time spent sedentary varies between 2.5 hours and 10 hours approximately in European countries. In America, this time is 8.44 hours on average. According to accelerometer data, the average total sedentary time of university students is 9.82 hours per day. Sedentary behaviour (SB) is associated with cardiometabolic risk markers and increased risk of cardiovascular disease, independent of moderate and vigorous physical activity (PA). Replacing sedentary time with PA of any intensity, including low-intensity, reduces all-cause mortality.

In terms of some cardiovascular risk variables (e.g., high triglycerides, glucose, LDL cholesterol, total cholesterol), data are insufficient and conflicting on the superiority of increasing non-exercise PA in addition to aerobic exercise over aerobic exercise alone. Additionally, to our knowledge, whether increasing non-exercise PA combined with aerobic exercise is superior to performing aerobic exercise alone in young overweight women with high sedentary time has not been investigated. Therefore, this study was planned to investigate whether reducing SB and increasing non-exercise PA combined with aerobic exercise in overweight young women between the ages of 18-35 is superior to performing aerobic exercise alone in terms of some cardiometabolic variables. For this purpose, overweight female individuals between the ages of 18-35 will be invited to the research. Thirty-two female volunteers who meet the inclusion and exclusion criteria will be randomly assigned to two different groups of this research. These groups will be as follows:

Aerobic Exercise Group: Participants in this group will do moderate-intensity aerobic training four days a week for 8 weeks.

Aerobic Exercise+non-Exercise Physical Activity Group: Participants in this group will reduce their sedentary time and increase non-exercise PA in addition to moderate-intensity aerobic training for four days a week for 8 weeks.

PA and SB data of the participants in both groups will be monitored with a wrist worn accelerometer throughout the study. At the beginning of the study, 4 weeks after the beginning and at the end of 8 weeks, participants will be evaluated in terms of the cardiometabolic variables. These variables are fasting serum glucose, triglyceride, HDL cholesterol, LDL cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, cardiorespiratory fitness, body mass index, waist and hip circumference, and body fat percentage. If there is a difference between the two group averages in terms of all variables and the group-time interactions test assumptions are met, analysis will be made with two-way mixed analysis of variance (ANOVA). Since 3 measurements will be made over time, pairwise differences in change over time will be analyzed with a post hoc Bonferroni test.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
32
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
  • Being on antidiabetic medication
  • Being on systemic glucocorticoid medication
  • Smoking
  • Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) GroupIncreasing non-Exercise Physical ActivityParticipants in this group will increase their non-exercise physical activities and do moderate-intensity aerobic training for four days a week for 8 weeks.
Aerobic Exercise (AeroEx) GroupAerobic ExerciseParticipants in this group will do moderate-intensity aerobic training for 4 days a week for 8 weeks.
Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) GroupAerobic ExerciseParticipants in this group will increase their non-exercise physical activities and do moderate-intensity aerobic training for four days a week for 8 weeks.
Primary Outcome Measures
NameTimeMethod
Serum TriglyceridesThe week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

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.

Maximal Oxygen ConsumptionThe week before the beginning of the interventions, and the week after the interventions

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

Low Density Lipoprotein (LDL) CholesterolThe week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

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.

Glycated Hemoglobin (HbA1C)The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

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.

High Density Lipoprotein (HDL) CholesterolThe week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

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.

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

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.

Systolic Blood PressureThe week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

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.

Diastolic Blood PressureThe week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

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.

Secondary Outcome Measures
NameTimeMethod
Fat-free MassThe week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

Fat-free mass will be measured by bioelectrical impedance analysis

Body Fat PercentageThe week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions

Body fat percentage will be measured by bioelectrical impedance analysis

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

Waist circumference will be measured in centimeters in the horizontal plane with a tape measure from the narrowest part of the waist area, with feet together, immediately after normal expiration without holding the breath.

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

Hip circumference will be measured in centimeters in the horizontal plane with a tape measure from the widest part of the hip.

Trial Locations

Locations (1)

Kastamonu University, Çatalzeytin Vocational School

🇹🇷

Çatalzeyti̇n, Kastamonu, Turkey

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