NCT07350213

Brief Summary

This study investigated the effects of a step-aerobics program versus a core exercise program on serum non-HDL-C levels and other cardiometabolic parameters in sedentary women with overweight/obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 28, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

ExerciseOverweightObesityWomenCholesterol, Non-HDL

Outcome Measures

Primary Outcomes (1)

  • Serum Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) levels measured via enzymatic assay (mg/dL)on HDL levels in overweight or obese, sedentary individuals.

    Fasting venous blood samples will be collected at baseline and after the 16-week intervention. Serum Non-HDL-C will be calculated as Total Cholesterol minus High-Density Lipoprotein Cholesterol (HDL-C) using enzymatic assay methodology. Results will be reported as mean ± standard deviation (SD) and percentage change (%) from baseline. Between-group differences in change scores will be compared using independent samples t-tests with significance level set at p \< 0.05.

    Baseline (Week 0) and Post-Intervention (Week 16)

Secondary Outcomes (4)

  • Serum Total Cholesterol levels measured via enzymatic assay (mg/dL)

    Baseline (Week 0) and Post-Intervention (Week 16)

  • Serum Low-Density Lipoprotein Cholesterol (LDL-C) levels measured via enzymatic assay (mg/dL)

    Baseline (Week 0) and Post-Intervention (Week 16)

  • Serum High-Density Lipoprotein Cholesterol (HDL-C) levels measured via enzymatic assay (mg/dL)

    Baseline (Week 0) and Post-Intervention (Week 16)

  • Serum Triglycerides levels measured via enzymatic assay (mg/dL)

    Baseline (Week 0) and Post-Intervention (Week 16)

Other Outcomes (3)

  • Body Mass Index (BMI) calculated from body weight and height (kg/m²)

    Baseline (Week 0) and Post-Intervention (Week 16)

  • Waist Circumference measured at the midpoint between the iliac crest and the lowest rib (cm)

    Baseline (Week 0) and Post-Intervention (Week 16)

  • Resting Heart Rate measured via validated heart rate monitors (beats per minute, bpm)

    Baseline (Week 0) and Post-Intervention (Week 16)

Study Arms (2)

step-aerobics group

ACTIVE COMPARATOR

The aerobic-step exercise training protocol included methodically planned 60-minute training sessions with the following components: Warm-up Phase (10 minutes): Low-intensity aerobic movements that are intended to slowly raise heart rate and ready the cardiovascular system for more vigorous exercise. This phase consisted of low stepping movements, arm circles, and dynamic stretching exercises. Main Exercise Phase (40 minutes): Aerobic-step exercise routines done on adjustable step platforms.Step height was individualized according to participant fitness level and progressed incrementally during the course of the intervention. Exercises consisted of simple step-ups, lateral steps, knee lifts, and complex choreographed movement patterns incorporating both lower and upper body movements. Music with suitable tempo was used to help maintain rhythm and motivation. Cool-down Phase (10 minutes): Progressive decrease in the intensity of exercise coupled

Other: Step-Aerobics GroupOther: Core Exercise Group

core exercise group

ACTIVE COMPARATOR

Warm-up Phase (10 minutes): Simple aerobic movements akin to the step group but with focus on core engagement and spinal mobility. This phase involved marching in place, slow torso rotations, and preparatory core engagement exercises. Main Exercise Phase (40 minutes): Strength and stability exercises targeting the core and integrating aerobic movements. Planks, modified crunches, bridge exercises, stability ball exercises, Pilates160 inspired movements, and functional core strengthening exercises were included in this phase. The aerobic element was preserved by using continuous movement patterns and circuit-style training to keep heart rate within the desired zone.

Other: Step-Aerobics GroupOther: Core Exercise Group

Interventions

Step Aerobics: The primary goal is to improve cardiovascular health and burn calories. It mainly targets the lower body muscles, including the legs, glutes, and calves. The arms and core also engage to keep pace with the rhythm.

core exercise groupstep-aerobics group

The primary goal is to stabilize and strengthen the body's center (abs, lower back, hips, and the area surrounding the spine). The focus is on resistance and balance rather than mobility. These exercises target the core region, including deep abdominal muscles, lower back muscles, the pelvic floor, and the diaphragm. They are generally more static (stationary) or controlled.

core exercise groupstep-aerobics group

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study investigated the effects of a step-aerobics program versus a core exercise program on serum non-HDL-C levels and other cardiometabolic parameters in sedentary women with overweight/obesity.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female sex, aged 25-45 years.
  • Sedentary lifestyle, defined as engaging in less than 150 minutes of moderate-intensity physical activity per week for the preceding six months.
  • Overweight or Class I Obesity, defined according to World Health Organization (WHO) criteria as a Body Mass Index (BMI) between 25.0 and 34.9 kg/m².
  • Willingness to participate in a 16-week supervised exercise program and provide written informed consent.

You may not qualify if:

  • Presence of diagnosed CVD, uncontrolled hypertension (Systolic Blood Pressure \>140 mmHg or Diastolic Blood Pressure \>90 mmHg), or diabetes mellitus (Type 1 or 2).
  • Current or past use (within 6 months) of lipid-lowering medications, antihypertensive drugs, or any medication known to affect metabolism.
  • Active smoking.
  • Pregnancy or lactation.
  • Any musculoskeletal, orthopedic, or other medical condition that would prevent safe participation in the exercise programs.
  • Participation in any structured, regular exercise program within the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University

Menteşe, Muğla, 48050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityOverweightObesity

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The patients were randomly assigned, in a 1:1 ratio, into one of two groups of intervention: step-aerobics group (SAG) or core exercise group (CEG). An independent researcher produced the random sequence by computer-based random number generator.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups with a step aerobics group or a core exercise group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

December 28, 2025

First Posted

January 20, 2026

Study Start

April 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations