Clinical trial NCT06270810: Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity
Official title: Cardiometabolic Effects of Increasing Non-Exercise Physical Activity Combined With Aerobic Exercise in Overweight Young Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Low Density Lipoprotein (LDL) Cholesterol
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: High Density Lipoprotein (HDL) Cholesterol
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Total Cholesterol
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Glycated Hemoglobin (HbA1C)
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Serum Triglycerides
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Maximal Oxygen Consumption
timeFrame: The week before the beginning of the interventions, and the week after the interventions
measure: Systolic Blood Pressure
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Diastolic Blood Pressure
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Secondary outcomes:
measure: Body Fat Percentage
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Fat-free Mass
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Waist Circumference
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
measure: Hip Circumference
timeFrame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Other outcomes:
Locations:
city: Çatalzeyti̇n
country: Turkey
facility: Kastamonu University, Çatalzeytin Vocational School
state: Kastamonu
Study officials:
References:
citation: 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.
citation: 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.