PostmenopausalCARE+ENCT07377383
Cardiometabolic Adaptations to Concurrent Training: Effect of Effort Configuration on Postmenopausal Women
A study testing Concurrent Training Program in people with Postmenopausal and Hypertension, run by Universidade da Coruña at 1 site in Spain.
Trial summary
The main objectives of this project are to assess the effects of a 20-week concurrent training program on neuromuscular adaptations, body composition, cardiometabolic health, quality of life, mood state, physical self-perception, and menopause-related symptoms in physically active postmenopausal women, and to compare… Read more about this study
- Who is it for?
- Ages 46 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal, Hypertension
- What is being tested?
- Concurrent Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 4 May 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 46 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one year since the last menstrual period.
- Physically active, defined as engaging in 150-300 minutes of moderate physical activity per week or at least 75 minutes of vigorous activity per week.
- Three or fewer traditional cardiovascular risk factors.
- Asymptomatic and without cardiovascular (except controlled hypertension), metabolic, or renal diseases.
- In the case of hypertensive participants, well-controlled grade 1 hypertension managed with a single medication.
Who cannot join
- Diagnosis of grade 2 or grade 3 hypertension.
- Hypertension managed with more than one medication or with a drug that could interfere with cardiovascular responses to exercise (e.g., beta-blockers).
- Current or prior use of hormone replacement therapy.
- Hypertensive response to exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Sport Sciences and Physical Education - UDC
Oleiros, A Coruña, 1517
Eliseo Iglesias Soler, PhD, +34981167000 ext. 4061, eliseo.iglesias.soler@udc.es
María Rúa Alonso, PhD, +34981167000 ext. 4079, maria.rua@udc.es
About this study
Official title: Cardiometabolic Adaptations to Resistance and Endurance Exercise: Effects of Effort Configuration in Concurrent Training for Postmenopausal Women
The main objectives of this project are to assess the effects of a 20-week concurrent training program on neuromuscular adaptations, body composition, cardiometabolic health, quality of life, mood state, physical self-perception, and menopause-related symptoms in physically active postmenopausal women, and to compare the adaptations resulting from different combinations of endurance and resistance training programs with varying effort configurations.
Additionally, this project aims to examine the longitudinal interaction and potential interference effects between endurance and resistance training effort configurations throughout the training program and to determine the optimal combination of effort configurations that maximizes health benefits in concurrent training programs for physically active postmenopausal women.
Read the detailed description
Menopause has a deleterious effect on women's health. The withdrawal of estrogens is associated with changes in body fat distribution, reduced glucose tolerance, abnormal lipid profiles, increased blood pressure, heightened sympathetic tone, endothelial dysfunction, and vascular inflammation. Training programs that combine endurance and resistance exercises-commonly referred to as concurrent training (CT) - at an optimal dose are recommended to counteract or even reverse some of the adverse effects of menopause.
This project builds upon a previous study conducted as part of a previous research project (PID2021-124277OB-I00), which examined the cardiovascular, metabolic, neuromuscular, and perceptual responses and adaptations of postmenopausal women to resistance training programs with different set configurations. The present proposal (CARE+E) extends this line of research by systematically incorporating the endurance component into CT programs and by manipulating effort configuration in both resistance and endurance exercises, thereby addressing a major limitation of the previous project, in which the cardiorespiratory training component was not experimentally controlled.
The inclusion of endurance training within a controlled CT framework enables the analysis of how resistance and endurance stimuli interact over time. In this context, the interference phenomenon, defined as the attenuation of adaptations induced by one exercise modality when it is combined with another within a concurrent training program, has been widely discussed but remains insufficiently understood, particularly with respect to the role of training load distribution. Effort configuration, defined as the duration of exercise sets relative to the maximal effort that can be sustained at a given intensity, may represent a key factor influencing this interaction. Nevertheless, the combined cardiometabolic and neuromuscular effects of different effort configurations in CT programs have not been systematically investigated, and evidence in physically active postmenopausal women is currently lacking.
By implementing a 20-week intervention, this project extends beyond the short- and medium-term durations typically used in postmenopausal populations, allowing for the evaluation of chronic adaptations to concurrent training. Periodic assessments throughout the program will provide insight into the longitudinal evolution of interactions between endurance and resistance training and will enable the identification of combinations of effort configurations that maximize health-related benefits. In this way, the project will generate novel evidence to inform the design of optimized concurrent training prescriptions tailored to the specific physiological characteristics of physically active postmenopausal women.
- Conditions
- Postmenopausal, Hypertension
- Being tested
- Concurrent Training Program
- Keywords
- postmenopausal women, cardiovascular adaptations, concurrent training, resistance training, endurance training, interference phenomenon
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Training ProgramOther
All participants will follow a 20-week concurrent training program consisting of four supervised training sessions per week: two sessions of endurance training and two sessions of resistance training. Each resistance training session will include exercises targeting major muscle groups (leg press, bench press, prone leg curl, and lat pull-down). All exercises will be performed using the 12-repetition maximum load, completing a total of 36 repetitions per exercise. Inter-set rest periods will be arranged so that the total rest time per exercise is 6 minutes, maintaining a consistent work-to-rest ratio. Recovery between exercises will be 4 minutes. will consist of cycling exercises performed at prescribed intensities determined from incremental exercise testing. All sessions will have a total duration of thirty minutes. Work and recovery intervals will be arranged to maintain a consistent work-to-rest ratio across all participants.
| Study group | Role | What they receive |
|---|---|---|
| Short Set Configuration (4S) + Moderate-Intensity Continuous Training (MICT) | Experimental | Postmenopausal women perform a resistance training protocol with a Short Set Configuration (4 sets × 9 repetitions, 45 s inter-set rest, 4 min between exercises) and moderate-intensity continuous cycling (30 min at ~85% of anaerobic threshold). Receives: Other: Concurrent Training Program |
| Concurrent Training: Long Set Configuration (9S) + Moderate-Intensity Continuous Training (MICT) | Experimental | Postmenopausal women perform a resistance training protocol with a Long Set Configuration (9 sets × 4 repetitions, 120 s inter-set rest, 4 min between exercises) and moderate-intensity continuous cycling (30 min at ~85% of anaerobic threshold). Receives: Other: Concurrent Training Program |
| Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 30% TTE (AIT30) | Experimental | Postmenopausal women perform a resistance training protocol with a Short Set Configuration (4 sets × 9 repetitions, 45 s inter-set rest, 4 min between exercises) and aerobic interval training at low effort configuration (work intervals = 30% TTE, rest intervals adjusted to maintain work-to-rest ratio). Receives: Other: Concurrent Training Program |
| Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 30% TTE (AIT30) | Experimental | Postmenopausal women perform a resistance training protocol with a Long Set Configuration (9 sets × 4 repetitions, 120 s inter-set rest, 4 min between exercises) and aerobic interval training at low effort configuration (work intervals = 30% TTE, rest intervals adjusted to maintain work-to-rest ratio). Receives: Other: Concurrent Training Program |
| Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 75% TTE (AIT75) | Experimental | Postmenopausal women perform a resistance training protocol with a Short Set Configuration (4 sets × 9 repetitions, 45 s inter-set rest, 4 min between exercises) and aerobic interval training at high effort configuration (work intervals = 75% TTE, 1:1 work-to-rest ratio). Receives: Other: Concurrent Training Program |
| Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 75% TTE (AIT75) | Experimental | Postmenopausal women perform a resistance training protocol with a Long Set Configuration (9 sets × 4 repetitions, 120 s inter-set rest, 4 min between exercises) and aerobic interval training at high effort configuration (work intervals = 75% TTE, 1:1 work-to-rest ratio). Receives: Other: Concurrent Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Baroreflex sensitivity
Simultaneous electrocardiogram and beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor will be used for calculating baroreflex sensitivity by sequential methods. Units: mmHg/ms
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Heart rate variability in time domain
Standard deviation of the normal-to-normal interval (SDNN) and root of the mean squared differences of successive NN intervals (RMSSD) will be obtained by analyzing inter-beat intervals from electrocardiogram recordings. Units: ms
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Heart rate variability in frequency domain
Obtained from spectral analysis of electrocardiogram recordings. High (HF) and Low (LF) frequency bands power will be determined by Fast Fourier Transformation method. Units: ms2/Hz
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Blood pressure variability
It will be calculated by spectral analysis of beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor. Units: mmHg2/Hz.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Arterial stiffness
Pulse wave velocity will be measured at both the carotid-femoral and finger-toe segments. Units: m/s.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Resting metabolic rate
It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Health-related quality of life (HRQoL)
Health-Related Quality of Life assessed using the Cervantes Scale, which evaluates overall quality of life in postmenopausal women. The scale ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Menopause-Related Symptoms
Menopause-Related Symptoms assessed using the Greene Climacteric Scale, which quantifies the severity and frequency of menopause symptoms. The scale ranges from 0 to 63, with higher scores indicating more severe menopause-related symptoms.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Mood State
Mood State assessed using the Evaluation of Emotional States Mood Assessment Scale, which evaluates different dimensions of mood in participants. The scale ranges from 0 to 100, with higher scores indicating more positive mood.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Physical Self-Perception
Physical Self-Perception assessed using the Physical Self-Perception Profile Scale, which evaluates body image and perceived physical competence. The scale ranges from 1 to 6, with higher scores indicating greater perceived physical competence and more positive body image.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Blood Lipid Profile
Biochemical variables related to dyslipidemia, including total cholesterol, LDL, HDL, and triglycerides, measured using a portable cholesterol analyzer (ACON Laboratories, USA).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Blood Glucose
Fasting Blood Glucose measured in milligrams per deciliter using a multiparameter monitor (Gimacare, Gima S.P.A., Italy).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Oxidative Stress Markers (Total Antioxidant Capacity)
Total Antioxidant Capacity measured in millimoles of Trolox equivalents per liter using the BRS-BQC Redox System (BQC Redox Technologies, Spain).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Power-velocity relationship
Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Maximum isometric torque
Maximum torque recorded at fixed angular position. It will be measured with an isokinetic dynamometer. Units: N/m
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Hemoglobin
Hemoglobin concentration measured in grams per deciliter using a multiparameter monitor (Gimacare, Gima S.P.A., Italy).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Oxidative Stress Markers (Hydrogen Peroxide Scavenging Capacit)
Hydrogen Peroxide Scavenging Capacity measured in micromoles per liter using the BRS-BQC Redox System (BQC Redox Technologies, Spain).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Secondary outcomes (14)
Physical Activity Level
Physical Activity Level assessed using the International Physical Activity Questionnaire, which evaluates walking, moderate-intensity, and vigorous-intensity activities performed in a typical week across all domains of daily life, including leisure time activities, domestic and gardening activities, work-related activities, and transport activities.
Participants are classified into three categories: Inactive (not meeting the criteria for minimally active or health-enhancing physical activity active), Minimally Active (achieving at least six hundred metabolic equivalent minutes per week through a combination of activity types), and Health-Enhancing Physical Activity Active (exceeding the minimum recommended levels of physical activity for health). Higher categories indicate greater habitual physical activity and better adherence to public health recommendations.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Dietary Habits
Assessed using the Short Diet Quality Screener (SDQS) questionnaire to evaluate dietary patterns and quality.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Body Composition: Body Fat Percentage
Body Fat Percentage measured in percent using multifrequency bioimpedance (Bodystat Quadscan 4000, Quadscan, United Kingdom).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Bone Mineral Density
Estimated bone mineral density assessed using ultrasound densitometry (Sonost 3000, Osteosys Corp., Korea).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Muscle Morphology
Muscle thickness and cross-sectional area of biceps brachii and vastus lateralis measured by ultrasound (Versana Active device with 12L-RS linear probe, GE HealthCare, USA).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Cardiorespiratory Fitness (Peak oxygen uptake)
Peak Oxygen Uptake, in order to asses the cardiorespirtoty fitness, measured in milliliters per kilogram per minute during an incremental cycle ergometer test.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Time to Exhaustion (TTE)
Duration (in seconds or minutes) that participants maintain a power output corresponding to 90% of VO₂max at a cadence of 75-85 rpm during a constant-load cycling test.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Balance
Postural stability measured by center of pressure displacement during the Romberg test using a force platform (Kistler Instrumente AG, Switzerland).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Muscular Strength
Assessed using the 12RM load for each resistance exercise, with execution velocity recorded to evaluate the loss of propulsive velocity during repetitions.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Body Composition: Lean Mass
Lean Mass measured in kilograms using multifrequency bioimpedance (Bodystat Quadscan 4000, Quadscan, United Kingdom).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Body Composition: Total Body Water
Total Body Water measured in liters using multifrequency bioimpedance (Bodystat Quadscan 4000, Quadscan, United Kingdom).
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Exercise Heart Rate
Heart Rate measured in beats per minute during an incremental cycle ergometer test.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Exercise Blood Pressure
Systolic nad Diastolic Blood Pressure measured in millimeters of mercury during an incremental cycle ergometer test.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Individualized Power Output
Individualized Power Output measured in watts, determined from the regression between external load and percentage of maximal oxygen uptake during an incremental cycle ergometer test.
Measured: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start4 May 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Eliseo Iglesias Soler, Universidade da Coruña
- Investigators
- Eliseo Iglesias-Soler, PhD, Principal investigator, Universidade da CoruñaMaría Rúa-Alonso, PhD, Principal investigator, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377383
- Sponsor's protocol ID
- PID2024-156481OB-I00
- Acronym
- CARE+E
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After finishing the protocols (six months approximately) main data will be shared through European data repository Zenodo, in which University of A Coruna has created a community
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Adaptations to Resistance and Endurance Exercise: Effects of Effort Configuration in Concurrent Training for Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07377383
- Acronym / sponsor ID
- CARE+E / PID2024-156481OB-I00
- Conditions
- Postmenopausal, Hypertension
- Keywords
- postmenopausal women, cardiovascular adaptations, concurrent training, resistance training, endurance training, interference phenomenon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 4 May 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
The main objectives of this project are to assess the effects of a 20-week concurrent training program on neuromuscular adaptations, body composition, cardiometabolic health, quality of life, mood state, physical self-perception, and menopause-related symptoms in physically active postmenopausal women, and to compare the adaptations resulting from different combinations of endurance and resistance training programs with varying effort configurations.
Additionally, this project aims to examine the longitudinal interaction and potential interference effects between endurance and resistance training effort configurations throughout the training program and to determine the optimal combination of effort configurations that maximizes health benefits in concurrent training programs for physically active postmenopausal women.
Detailed description
Menopause has a deleterious effect on women's health. The withdrawal of estrogens is associated with changes in body fat distribution, reduced glucose tolerance, abnormal lipid profiles, increased blood pressure, heightened sympathetic tone, endothelial dysfunction, and vascular inflammation. Training programs that combine endurance and resistance exercises-commonly referred to as concurrent training (CT) - at an optimal dose are recommended to counteract or even reverse some of the adverse effects of menopause.
This project builds upon a previous study conducted as part of a previous research project (PID2021-124277OB-I00), which examined the cardiovascular, metabolic, neuromuscular, and perceptual responses and adaptations of postmenopausal women to resistance training programs with different set configurations. The present proposal (CARE+E) extends this line of research by systematically incorporating the endurance component into CT programs and by manipulating effort configuration in both resistance and endurance exercises, thereby addressing a major limitation of the previous project, in which the cardiorespiratory training component was not experimentally controlled.
The inclusion of endurance training within a controlled CT framework enables the analysis of how resistance and endurance stimuli interact over time. In this context, the interference phenomenon, defined as the attenuation of adaptations induced by one exercise modality when it is combined with another within a concurrent training program, has been widely discussed but remains insufficiently understood, particularly with respect to the role of training load distribution. Effort configuration, defined as the duration of exercise sets relative to the maximal effort that can be sustained at a given intensity, may represent a key factor influencing this interaction. Nevertheless, the combined cardiometabolic and neuromuscular effects of different effort configurations in CT programs have not been systematically investigated, and evidence in physically active postmenopausal women is currently lacking.
By implementing a 20-week intervention, this project extends beyond the short- and medium-term durations typically used in postmenopausal populations, allowing for the evaluation of chronic adaptations to concurrent training. Periodic assessments throughout the program will provide insight into the longitudinal evolution of interactions between endurance and resistance training and will enable the identification of combinations of effort configurations that maximize health-related benefits. In this way, the project will generate novel evidence to inform the design of optimized concurrent training prescriptions tailored to the specific physiological characteristics of physically active postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Short Set Configuration (4S) + Moderate-Intensity Continuous Training (MICT) | Experimental | Other: Concurrent Training ProgramPostmenopausal women perform a resistance training protocol with a Short Set Configuration (4 sets × 9 repetitions, 45 s inter-set rest, 4 min between exercises) and moderate-intensity continuous cycling (30 min at ~85% of anaerobic threshold). |
| Concurrent Training: Long Set Configuration (9S) + Moderate-Intensity Continuous Training (MICT) | Experimental | Other: Concurrent Training ProgramPostmenopausal women perform a resistance training protocol with a Long Set Configuration (9 sets × 4 repetitions, 120 s inter-set rest, 4 min between exercises) and moderate-intensity continuous cycling (30 min at ~85% of anaerobic threshold). |
| Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 30% TTE (AIT30) | Experimental | Other: Concurrent Training ProgramPostmenopausal women perform a resistance training protocol with a Short Set Configuration (4 sets × 9 repetitions, 45 s inter-set rest, 4 min between exercises) and aerobic interval training at low effort configuration (work intervals = 30% TTE, rest intervals adjusted to maintain work-to-rest ratio). |
| Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 30% TTE (AIT30) | Experimental | Other: Concurrent Training ProgramPostmenopausal women perform a resistance training protocol with a Long Set Configuration (9 sets × 4 repetitions, 120 s inter-set rest, 4 min between exercises) and aerobic interval training at low effort configuration (work intervals = 30% TTE, rest intervals adjusted to maintain work-to-rest ratio). |
| Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 75% TTE (AIT75) | Experimental | Other: Concurrent Training ProgramPostmenopausal women perform a resistance training protocol with a Short Set Configuration (4 sets × 9 repetitions, 45 s inter-set rest, 4 min between exercises) and aerobic interval training at high effort configuration (work intervals = 75% TTE, 1:1 work-to-rest ratio). |
| Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 75% TTE (AIT75) | Experimental | Other: Concurrent Training ProgramPostmenopausal women perform a resistance training protocol with a Long Set Configuration (9 sets × 4 repetitions, 120 s inter-set rest, 4 min between exercises) and aerobic interval training at high effort configuration (work intervals = 75% TTE, 1:1 work-to-rest ratio). |
Who may qualify
- Ages
- 46 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least one year since the last menstrual period.
- Physically active, defined as engaging in 150-300 minutes of moderate physical activity per week or at least 75 minutes of vigorous activity per week.
- Three or fewer traditional cardiovascular risk factors.
- Asymptomatic and without cardiovascular (except controlled hypertension), metabolic, or renal diseases.
- In the case of hypertensive participants, well-controlled grade 1 hypertension managed with a single medication.
Key exclusion criteria (4 listed)
- Diagnosis of grade 2 or grade 3 hypertension.
- Hypertension managed with more than one medication or with a drug that could interfere with cardiovascular responses to exercise (e.g., beta-blockers).
- Current or prior use of hormone replacement therapy.
- Hypertensive response to exercise.
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 |
|---|---|---|
| Concurrent Training ProgramAll participants will follow a 20-week concurrent training program consisting of four supervised training sessions per week: two sessions of endurance training and two sessions of resistance training. Each resistance training session will include exercises targeting major muscle groups (leg press, bench press, prone leg curl, and lat pull-down). All exercises will be performed using the 12-repetition maximum load, completing a total of 36 repetitions per exercise. Inter-set rest periods will be arranged so that the total rest time per exercise is 6 minutes, maintaining a consistent work-to-rest ratio. Recovery between exercises will be 4 minutes. will consist of cycling exercises performed at prescribed intensities determined from incremental exercise testing. All sessions will have a total duration of thirty minutes. Work and recovery intervals will be arranged to maintain a consistent work-to-rest ratio across all participants. | Other | Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 30% TTE (AIT30), Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 75% TTE (AIT75), Concurrent Training: Long Set Configuration (9S) + Moderate-Intensity Continuous Training (MICT), Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 30% TTE (AIT30), Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 75% TTE (AIT75), Short Set Configuration (4S) + Moderate-Intensity Continuous Training (MICT) |
Primary outcome
Blood pressure
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg
Baroreflex sensitivity
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Simultaneous electrocardiogram and beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor will be used for calculating baroreflex sensitivity by sequential methods. Units: mmHg/ms
Heart rate variability in time domain
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Standard deviation of the normal-to-normal interval (SDNN) and root of the mean squared differences of successive NN intervals (RMSSD) will be obtained by analyzing inter-beat intervals from electrocardiogram recordings. Units: ms
Heart rate variability in frequency domain
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Obtained from spectral analysis of electrocardiogram recordings. High (HF) and Low (LF) frequency bands power will be determined by Fast Fourier Transformation method. Units: ms2/Hz
Blood pressure variability
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
It will be calculated by spectral analysis of beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor. Units: mmHg2/Hz.
Arterial stiffness
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Pulse wave velocity will be measured at both the carotid-femoral and finger-toe segments. Units: m/s.
Resting metabolic rate
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day
Health-related quality of life (HRQoL)
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Health-Related Quality of Life assessed using the Cervantes Scale, which evaluates overall quality of life in postmenopausal women. The scale ranges from 0 to 100, with higher scores indicating better quality of life.
Menopause-Related Symptoms
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Menopause-Related Symptoms assessed using the Greene Climacteric Scale, which quantifies the severity and frequency of menopause symptoms. The scale ranges from 0 to 63, with higher scores indicating more severe menopause-related symptoms.
Mood State
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Mood State assessed using the Evaluation of Emotional States Mood Assessment Scale, which evaluates different dimensions of mood in participants. The scale ranges from 0 to 100, with higher scores indicating more positive mood.
Physical Self-Perception
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Physical Self-Perception assessed using the Physical Self-Perception Profile Scale, which evaluates body image and perceived physical competence. The scale ranges from 1 to 6, with higher scores indicating greater perceived physical competence and more positive body image.
Blood Lipid Profile
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Biochemical variables related to dyslipidemia, including total cholesterol, LDL, HDL, and triglycerides, measured using a portable cholesterol analyzer (ACON Laboratories, USA).
Blood Glucose
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Fasting Blood Glucose measured in milligrams per deciliter using a multiparameter monitor (Gimacare, Gima S.P.A., Italy).
Oxidative Stress Markers (Total Antioxidant Capacity)
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Total Antioxidant Capacity measured in millimoles of Trolox equivalents per liter using the BRS-BQC Redox System (BQC Redox Technologies, Spain).
Power-velocity relationship
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer
Maximum isometric torque
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Maximum torque recorded at fixed angular position. It will be measured with an isokinetic dynamometer. Units: N/m
Hemoglobin
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Hemoglobin concentration measured in grams per deciliter using a multiparameter monitor (Gimacare, Gima S.P.A., Italy).
Oxidative Stress Markers (Hydrogen Peroxide Scavenging Capacit)
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Hydrogen Peroxide Scavenging Capacity measured in micromoles per liter using the BRS-BQC Redox System (BQC Redox Technologies, Spain).
14 secondary outcomes
Physical Activity Level
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Dietary Habits
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Body Composition: Body Fat Percentage
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Bone Mineral Density
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Muscle Morphology
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Cardiorespiratory Fitness (Peak oxygen uptake)
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Time to Exhaustion (TTE)
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Balance
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Muscular Strength
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Body Composition: Lean Mass
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Body Composition: Total Body Water
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Exercise Heart Rate
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Exercise Blood Pressure
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Individualized Power Output
Time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. After finishing the protocols (six months approximately) main data will be shared through European data repository Zenodo, in which University of A Coruna has created a community
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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.
Eliseo Iglesias-Soler, PhD principal investigator
Universidade da Coruña
María Rúa-Alonso, PhD principal investigator
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Training Program in people with Postmenopausal and Hypertension, run by Universidade da Coruña 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliseo Iglesias-Soler, PhD (+3498167000 ext. 4061, eliseo.iglesias.soler@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)). The study lists 18 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 7 Jul 2026.