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

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

Study Overview

• Status: Completed
• Conditions: Postmenopausal; Sedentary Lifestlye; Obese Women; Women Veterans
• Intervention / Treatment: Behavioral: High-Intensity Interval; Behavioral: concurrent training; Behavioral: Control Group

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-intensity interval training (HIIT); The HIIT group performed treadmill or overground running/walking intervals consisting of 60 s at 90-95% of maximal heart rate (HRmax), interspersed with 60 s of active recovery at 55-60% HRmax (40) HRmax was estimated individually using the Tanaka et al. equation (41) (HRmax = 208 - 0.7 × age), which has been validated in middle-aged women. Session duration ranged from approximately 25 to 35 min (excluding warm-up and cool-down).	Behavioral: High-Intensity Interval; HIIT consisted of alternating high- (90-95 % HR_max) and low-intensity (55-60 % HR_max) aerobic bouts
Experimental: Concurrent Training (CONC); The CONC program integrated resistance and aerobic exercise within a single, periodized session designed to elicit both muscular and cardiovascular adaptations. Resistance component: Participants performed three sets per exercise targeting major muscle groups (leg press, chest press, seated row, shoulder press, leg curl, and abdominal crunch) with 1 min rest between sets. Training intensity progressed from 55% of one-repetition maximum (1RM) for 10-15 repetitions in week 1 to 75% 1RM for 8-12 repetitions by week 12. To ensure appropriate load progression, 1RM was reassessed every three weeks. Perceived exertion was recorded (Borg 6-20 scale), maintaining RPE 13-15 ("somewhat hard") to confirm compliance with relative intensity. Aerobic component: Participants completed 20 min of treadmill running or brisk walking, progressing from 55% HRmax in week 1 to 75% HRmax in week 12, in accordance with the protocol of Kargarfard et al. (44) and consistent with the concurrent training framework	Behavioral: concurrent training; combined aerobic and resistance exercises
Sham Comparator: Control Group; Participants assigned to the CG were instructed to maintain their usual daily routines and to refrain from engaging in any structured exercise or new physical activity programs during the 12-week intervention period.	Behavioral: Control Group; usual daily routines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Total Antioxidant Capacity (TAC)	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	first day of study and after 80 days of exercise training program (end of study)
Concentration Malondialdehyde (MDA) (nmol/mL)	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	first day of study and after 80 days of exercise training program (end of study)
Concentration Monocyte Chemoattractant Protein-1 (MCP-1) (pg/mL)	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	first day of study and after 80 days of exercise training program (end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Body Mass Index (BMI) is a simple calculation using your height and weight to estimate body fat	first day of study and after 80 days of exercise training program (end of study)
% Body Fat	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	first day of study and after 80 days of exercise training program (end of study)
Waist circumference (WC)	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)	first day of study and after 80 days of exercise training program (end of study)
hip circumference (HC)	Hip circumference (HC) is a key body measurement of the fullest part of your hips and buttocks	first day of study and after 80 days of exercise training program (end of study)
waist-hip ratio (WHR)	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).	first day of study and after 80 days of exercise training program (end of study)
total cholesterol (TC)	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)	first day of study and after 80 days of exercise training program (end of study)
Atherogenic Index of Plasma (AIP)	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	first day of study and after 80 days of exercise training program (end of study)
Serum insulin	Serum insulin refers to the amount of the hormone insulin circulating in your blood	first day of study and after 80 days of exercise training program (end of study)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	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.	first day of study and after 80 days of exercise training program (end of study)
Concentration Triglycerides (TG) (mg/dl)	Triglycerides are a common type of fat (lipid) in your blood, serving as the body's main way to store energy from food	first day of study and after 80 days of exercise training program (end of study)
Concentration High-Density Lipoprotein Cholesterol (HDL-C) (mg/dl)	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	first day of study and after 80 days of exercise training program (end of study)
Concentration Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dl)	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	first day of study and after 80 days of exercise training program (end of study)

Collaborators and Investigators

• Sponsor: University of Valladolid
• Collaborators: Ministerio de Ciencia e Innovación, Spain; Sanidad de Castilla y León; Fundación General Universidad de Valladolid
• Investigators: Principal Investigator: Diego F Fernández Lázaro, Vice Dean and Professor, University of Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Actual): November 20, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Estimated): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Oxidative stress; Inflammation; Obesity; Concurrent training; Menopause; High intensity interval training; Postmenopausal women
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Inflammation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Physical Conditioning, Human; Exercise; Control Groups; High-Intensity Interval Training
• Other Study ID Numbers: 2025.12.11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is withheld due to intellectual property rights, to avoid duplication, fear of criticism, time/resource limitations, or to ensure exclusive credit for the initial findings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No