Women VeteransHICONEXOBWONCT07302191
High-Intensity Interval or Concurrent Exercise on Oxidative Stress and Inflammation in Obese Women
A study testing High-Intensity Interval and concurrent training in people with Women Veterans and Obese Women, run by University of Valladolid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Women Veterans, Obese Women, Postmenopausal
- What is being tested?
- High-Intensity Interval and concurrent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2025to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- hormone replacement therapy
- smoking.
- diagnosed cardiovascular, renal, or hepatic disease, uncontrolled hypertension, or any musculoskeletal limitation precluding exercise participation
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences, University of Valladolid Soria Campus, Soria, Soria 42004
Soria, 42004
About this study
Official title: 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.
- Conditions
- Women Veterans, Obese Women, Postmenopausal, Sedentary Lifestlye
- Being tested
- High-Intensity Interval, concurrent training, Control Group
- Keywords
- Concurrent training, High intensity interval training, Postmenopausal women, Obesity, Oxidative stress, Inflammation, Menopause
- Medical subject headings
- Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity IntervalBehavioural
HIIT consisted of alternating high- (90-95 % HR_max) and low-intensity (55-60 % HR_max) aerobic bouts
concurrent trainingBehavioural
combined aerobic and resistance exercises
Control GroupBehavioural
usual daily routines
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: 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. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: first day of study and after 80 days of exercise training program (end of study)
Secondary outcomes (12)
Body Mass Index
Body Mass Index (BMI) is a simple calculation using your height and weight to estimate body fat
Measured: 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
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: first day of study and after 80 days of exercise training program (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start2 Sep 2025
- Primary completion20 Nov 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women VeteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Sanidad de Castilla y León, Ministerio de Ciencia e Innovación, Spain, Fundación General Universidad de Valladolid
- Responsible party
- Principal investigator, Diego Fernández Lázaro, University of Valladolid
- Investigators
- Diego F Fernández Lázaro, Vice Dean and Professor, Principal investigator, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302191
- Sponsor's protocol ID
- 2025.12.11
- Acronym
- HICONEXOBWO
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparable Reductions in Health Biomarkers Following High-Intensity Interval or Concurrent Training in Obese Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07302191
- Acronym / sponsor ID
- HICONEXOBWO / 2025.12.11
- Conditions
- Women Veterans, Obese Women, Postmenopausal, Sedentary Lifestlye
- Keywords
- Concurrent training, High intensity interval training, Postmenopausal women, Obesity, Oxidative stress, Inflammation, Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León, Ministerio de Ciencia e Innovación, Spain, Fundación General Universidad de Valladolid
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- parallel-group randomized controlled
| Arm | Type | Receives |
|---|---|---|
| high-intensity interval training (HIIT) | Experimental | Behavioral: High-Intensity IntervalThe 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). |
| Concurrent Training (CONC) | Experimental | Behavioral: concurrent trainingThe 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 |
| Control Group | Sham comparator | Behavioral: Control GroupParticipants 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- hormone replacement therapy
- smoking.
- diagnosed cardiovascular, renal, or hepatic disease, uncontrolled hypertension, or any musculoskeletal limitation precluding exercise participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity IntervalHIIT consisted of alternating high- (90-95 % HR_max) and low-intensity (55-60 % HR_max) aerobic bouts | Behavioural | high-intensity interval training (HIIT) |
| concurrent trainingcombined aerobic and resistance exercises | Behavioural | Concurrent Training (CONC) |
| Control Groupusual daily routines | Behavioural | Control Group |
Primary outcome
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
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
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
12 secondary outcomes
Body Mass Index
Time frame: first day of study and after 80 days of exercise training program (end of study)
% Body Fat
Time frame: first day of study and after 80 days of exercise training program (end of study)
Waist circumference (WC)
Time frame: first day of study and after 80 days of exercise training program (end of study)
hip circumference (HC)
Time frame: first day of study and after 80 days of exercise training program (end of study)
waist-hip ratio (WHR)
Time frame: first day of study and after 80 days of exercise training program (end of study)
total cholesterol (TC)
Time frame: first day of study and after 80 days of exercise training program (end of study)
Concentration Triglycerides (TG) (mg/dl)
Time frame: first day of study and after 80 days of exercise training program (end of study)
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)
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)
Atherogenic Index of Plasma (AIP)
Time frame: first day of study and after 80 days of exercise training program (end of study)
Serum insulin
Time frame: first day of study and after 80 days of exercise training program (end of study)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego F Fernández Lázaro, Vice Dean and Professor principal investigator
University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval and concurrent training in people with Women Veterans and Obese Women, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration Malondialdehyde (MDA) (nmol/mL) (time frame: first day of study and after 80 days of exercise training program (end of study)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.