- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703202
Step-Aerobics Versus Core Exercise for Non-HDL Cholesterol Reduction in Sedentary/Obesity Women
Step-Aerobics Versus Core Exercise for Non-HDL Cholesterol Reduction in Sedentary Women With Overweight/Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Non-high-density lipoprotein cholesterol (non-HDL-C) is a key predictor of cardiovascular disease (CVD), yet the comparative effects of different exercise modalities on this marker, particularly in high-risk populations, are not fully understood.
This study will investigate 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.
Study Design Overview Study Type: Randomized Controlled Trial Target Enrollment: Forty-five sedentary women with overweight/obesity Study Duration: 24 weeks Supervision: All exercise sessions will be professionally supervised
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Muğla
-
Menteşe, Muğla, Turkey (Türkiye), 48050
- Mugla Sitki Kocman University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female sex
- Aged 25-45 years
- Sedentary lifestyle (< 150 minutes/week of moderate-intensity activity for preceding 6 months)
- Overweight or Class I Obesity (BMI 25.0-34.9 kg/m²) per WHO criteria
- Willingness to participate in a 24-week supervised exercise program with written informed consent
Exclusion Criteria :
- Diagnosed cardiovascular disease (CVD)
- Uncontrolled hypertension (SBP >140 or DBP >90 mmHg)
- Diabetes mellitus (Type 1 or 2)
- Current/past lipid-lowering or antihypertensive medications (within 6 months)
- Active smoking
- Pregnancy or lactation
- Musculoskeletal/orthopedic conditions preventing safe exercise participation
- Structured exercise program participation within past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: step-aerobics group
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 |
Exercise Protocol Total Session Duration: 60 minutes Session Structure: Warm-up Phase (10 minutes) Low-intensity aerobic movements designed to slowly raise heart rate and prepare the cardiovascular system for more vigorous exercise. This phase consisted of: • Low stepping movements • Arm circles • Dynamic stretching exercises Main Exercise Phase (40 minutes) Aerobic-step exercise routines performed on adjustable step platforms. The protocol included: • Step Height: Individualized according to participant fitness level and progressed incrementally during the intervention • Exercise Components: • Simple step-ups • Lateral steps • Knee lifts • Complex choreographed movement patterns incorporating both lower and upper body movements • Music: Suitable tempo music was used to help maintain rhythm and motivation Cool-down Phase (10 minutes) Progressive decrease in exercise intensity coupled with: • Stretching exercises • Heart rate recovery period • Breathing exercises |
|
Active Comparator: core exercise group
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.
|
Exercise Protocol Total Session Duration: 60 minutes Session Structure: Warm-up Phase (10 minutes) Simple aerobic movements with focus on core engagement and spinal mobility. This phase involved: • Marching in place • Slow torso rotations • Preparatory core engagement exercises Main Exercise Phase (40 minutes) Strength and stability exercises targeting the core and integrating aerobic movements. The protocol included: • Planks (various variations) • Modified crunches • Bridge exercises • Stability ball exercises • Pilates-inspired movements • Functional core strengthening exercises • Aerobic Element: Continuous movement patterns and circuit-style training to keep heart rate within the desired zone Cool-down Phase (10 minutes) Progressive decrease in exercise intensity coupled with: • Stretching exercises (particularly core and lower back) • Heart rate recovery period • Breathing exercises and relaxation techniques |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum non-HDL-C levels (measured in mg/dL via standard lipid panel analysis)
Time Frame: 24 weeks
|
To analyze the effects of a 24-week supervised step aerobics and core exercise program on serum non-HDL-C levels (measured in mg/dL via standard lipid panel analysis) in overweight or obese, sedentary individuals.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- muglaSKU-CRD-OC-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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