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

University of Valladolid (UVA)

Status: Completed

Conditions: Women Veterans; Postmenopausal; Obese Women; Sedentary Lifestlye

Treatments: Behavioral: Control Group; Behavioral: concurrent training; Behavioral: High-Intensity Interval

Study type: Interventional

Funder types: Other

Identifiers

NCT07302191

2025.12.11

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 3 patient groups

high-intensity interval training (HIIT)

Experimental group

Description:

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).

Treatment:

Behavioral: High-Intensity Interval

Concurrent Training (CONC)

Experimental group

Description:

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

Treatment:

Behavioral: concurrent training

Control Group

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Control Group