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

NCT07302191 | Completed DMC

• 1 other identifier: 2025.12.11
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Women Veterans; Obese Women; Postmenopausal; Sedentary Lifestlye

Keywords

Concurrent training; High intensity interval training; Postmenopausal women; Obesity; Oxidative stress; Inflammation; Menopause

Outcome Measures

Primary Outcomes (3)

• 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)

• 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 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 Outcomes (12)

• Body Mass Index

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

• % Body Fat

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

• Waist circumference (WC)

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

• hip circumference (HC)

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

• waist-hip ratio (WHR)

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

Study Arms (3)

high-intensity interval training (HIIT)

EXPERIMENTAL

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

Concurrent Training (CONC)

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Interventions

High-Intensity Interval BEHAVIORAL

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

high-intensity interval training (HIIT)

concurrent training BEHAVIORAL

combined aerobic and resistance exercises

Concurrent Training (CONC)

Control Group BEHAVIORAL

usual daily routines

Control Group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: sedentary obese postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valladolid: lead
• Sanidad de Castilla y León: collaborator
• Ministerio de Ciencia e Innovación, Spain: collaborator
• Fundación General Universidad de Valladolid: collaborator

Study Sites (1)

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

Soria, 42004, Spain

Location

MeSH Terms

Conditions

Obesity; Inflammation

Interventions

High-Intensity Interval Training; Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Diego F Fernández Lázaro, Vice Dean and Professor

  University of Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: parallel-group randomized controlled

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: September 2, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 8, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)