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

NCT ID: NCT07302191

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2025-12-08

Brief Summary

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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.

Detailed Description

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Conditions

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Obese Women Postmenopausal Sedentary Lifestlye Women Veterans

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-group randomized controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

High-Intensity Interval

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

concurrent training

Intervention Type BEHAVIORAL

combined aerobic and resistance exercises

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.

Group Type SHAM_COMPARATOR

Control Group

Intervention Type BEHAVIORAL

usual daily routines

Interventions

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High-Intensity Interval

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

Intervention Type BEHAVIORAL

concurrent training

combined aerobic and resistance exercises

Intervention Type BEHAVIORAL

Control Group

usual daily routines

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* (a) at least 12 months of amenorrhea, (b) ability to exercise safely as determined by medical evaluation, and (c) sedentary status, defined as engaging in \<150 minutes of moderate-to-vigorous physical activity per week during the previous year.

Exclusion Criteria

* hormone replacement therapy, smoking, diagnosed cardiovascular, renal, or hepatic disease, uncontrolled hypertension, or any musculoskeletal limitation precluding exercise participation
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanidad de Castilla y León

OTHER

Sponsor Role collaborator

Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role collaborator

Fundación General Universidad de Valladolid

OTHER

Sponsor Role collaborator

University of Valladolid

OTHER

Sponsor Role lead

Responsible Party

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Diego Fernández Lázaro

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego F Fernández Lázaro, Vice Dean and Professor

Role: PRINCIPAL_INVESTIGATOR

University of Valladolid

Locations

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

Soria, SORIA, Spain

Site Status

Countries

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Spain

Other Identifiers

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2025.12.11

Identifier Type: -

Identifier Source: org_study_id