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Completed

NCT Number: NCT07302191

High-Intensity Interval or Concurrent Exercise on Oxidative Stress and Inflammation in Obese Women

Introduction: Menopause is associated with body composition change, an increase in the cardio-metabolic risk factor for oxidative stress. Nevertheless, it has been suggested that regular physical training is an effective non-pharmacological intervention to reduce oxidative stress and cardio-metabolic disorders in menopausal individuals. Therefore, the present study was conducted to compare the effects of twelve weeks of high-intensity interval training (HIIT) and concurrent (Conc) and on body composition, cardio-metabolic indices and oxidative stress in sedentary obese postmenopausal women.

Materials and methods: Forty-five menopausal obese women voluntarily participated and were randomly assigned into three groups: a) HIIT (6-12×60s of high intensity training (85-95% HRMax) and then running for 60 seconds with low intensity (55-60% HRMax)), b) concurrent endurance (performed on training with 55-75% HRMax) and strength training (including two sets in eight exercise stations with 55-75% 1RM)) and c) control group. Training programs were done for twelve weeks, 3 times per week. Body composition, cardio-metabolic indices and oxidative stress markers were measured before and after twelve weeks of exercise training program.

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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences, University of Valladolid Soria Campus, Soria, Soria 42004

Soria, 42004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with at least 12 months of amenorrhea.
  • Physical abilities with the capacity to exercise safely as determined by a medical evaluation.
  • Women in a sedentary state, defined as performing <150 minutes of moderate to vigorous physical activity per week during the previous year.
  • BMI >25 and ≤40 kg/ m2

Exclusion criteria

  • hormone replacement therapy
  • smoking.
  • diagnosed cardiovascular, renal, or hepatic disease, uncontrolled hypertension, or any musculoskeletal limitation precluding exercise participation

Treatment and study plan

High-Intensity Interval

Behavioral

HIIT consisted of alternating high- (90-95 % HR_max) and low-intensity (55-60 % HR_max) aerobic bouts

Concurrent Training

Behavioral

combined aerobic and resistance exercises

Control Group

Behavioral

usual daily routines

Primary outcomes

  1. Concentration Malondialdehyde (MDA) (nmol/mL)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Malondialdehyde (MDA) is a highly reactive compound and a key biomarker for oxidative stress, formed primarily from the breakdown (peroxidation) of polyunsaturated fatty acids in cell membranes, indicating cellular damage

  2. Serum Total Antioxidant Capacity (TAC)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Serum Total Antioxidant Capacity (TAC) measures the overall ability of antioxidants in your blood (serum) to neutralize harmful free radicals, reflecting your body's defense against oxidative stress, a key factor in aging and diseases

  3. Concentration Monocyte Chemoattractant Protein-1 (MCP-1) (pg/mL)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Monocyte Chemoattractant Protein-1 (MCP-1), also known as CCL2, is a vital CC chemokine that acts as a powerful signal, attracting monocytes, macrophages, and T cells to sites of inflammation, infection, and tissue injury in the body, playing a key role in innate immunity and various inflammatory diseases

Secondary outcomes

  1. Body Mass Index

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Body Mass Index (BMI) is a simple calculation using your height and weight to estimate body fat

  2. % Body Fat

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Body fat percentage is the proportion of your total body weight that is fat, not muscle, bone, or water, calculated as (Total Fat Mass / Total Body Mass) x 100

  3. Waist circumference (WC)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Waist circumference (WC) is a simple body measurement around your midsection (between the lowest rib and hip bone) used as an indicator of abdominal fat (visceral fat)

  4. hip circumference (HC)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Hip circumference (HC) is a key body measurement of the fullest part of your hips and buttocks

  5. waist-hip ratio (WHR)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    The Waist-to-Hip Ratio (WHR) is a simple measurement dividing your waist circumference by your hip circumference, showing how fat is distributed, especially around your midsection (belly).

  6. total cholesterol (TC)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Total Cholesterol (TC) is a blood test measuring all cholesterol in your blood, to assess heart disease risk, with healthy levels generally below 200 mg/dL (or 5.0 mmol/L)

  7. Concentration Triglycerides (TG) (mg/dl)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Triglycerides are a common type of fat (lipid) in your blood, serving as the body's main way to store energy from food

  8. Concentration High-Density Lipoprotein Cholesterol (HDL-C) (mg/dl)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    High-Density Lipoprotein Cholesterol is known as the "good" cholesterol because it helps remove bad cholesterol from your body by transporting it back to the liver for removal

  9. Concentration Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dl)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Low-Density Lipoprotein Cholesterol is often called "bad cholesterol" because high levels build up as plaque in your arteries, narrowing them and increasing your risk for heart attacks and strokes, even though high LDL levels usually have no symptoms

  10. Atherogenic Index of Plasma (AIP)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    he Atherogenic Index of Plasma (AIP) is a key indicator of cardiovascular risk, calculated as the log ratio of triglycerides (TG) to HDL cholesterol (HDL-C) (Log(TG/HDL-C)), reflecting impaired lipid metabolism and inflammation

  11. Serum insulin

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    Serum insulin refers to the amount of the hormone insulin circulating in your blood

  12. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: first day of study and after 80 days of exercise training program (end of study)

    HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a calculation that uses your fasting blood glucose and fasting insulin levels to estimate how resistant your body's cells are to insulin.

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Collaborators

  • Fundación General Universidad de Valladolid
  • Ministerio de Ciencia e Innovación, Spain
  • Sanidad de Castilla y León

Registry information

Official study title

Comparable Reductions in Health Biomarkers Following High-Intensity Interval or Concurrent Training in Obese Postmenopausal Women

Acronym: HICONEXOBWO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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