Cardiometabolic Adaptations to Concurrent Training: Effect of Effort Configuration on Postmenopausal Women
CARE+E
1 other identifier
interventional
60
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedStudy Start
First participant enrolled
May 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 28, 2026
April 1, 2026
2.6 years
December 24, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
Blood pressure
Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg
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
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
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
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.
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.
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
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.
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.
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.
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.
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).
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).
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).
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
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
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).
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).
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
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
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
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
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
Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24)
- +9 more secondary outcomes
Other Outcomes (5)
Health Status
Baseline (week 0)
Cardiovascular Risk Factors
Baseline (week 0)
Absolute and Relative Contraindications for Exercise
Baseline (week 0)
- +2 more other outcomes
Study Arms (6)
Short Set Configuration (4S) + Moderate-Intensity Continuous Training (MICT)
EXPERIMENTALPostmenopausal 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)
EXPERIMENTALPostmenopausal 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)
EXPERIMENTALPostmenopausal 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)
EXPERIMENTALPostmenopausal 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)
EXPERIMENTALPostmenopausal 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)
EXPERIMENTALPostmenopausal 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade da Coruñalead
- Ministerio de Ciencia e Innovación, Spaincollaborator
Study Sites (1)
Faculty of Sport Sciences and Physical Education - UDC
Oleiros, A Coruña, 1517, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eliseo Iglesias-Soler, PhD
Universidade da Coruña
- PRINCIPAL INVESTIGATOR
María Rúa-Alonso, PhD
Universidade da Coruña
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 24, 2025
First Posted
January 29, 2026
Study Start
May 5, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 months after finishing the whole project
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