NCT07377383

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

December 24, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

postmenopausal womencardiovascular adaptationsconcurrent trainingresistance trainingendurance traininginterference phenomenon

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)

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).

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).

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).

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).

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).

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).

Other: Concurrent Training Program

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.

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)

Eligibility Criteria

Age46 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Faculty of Sport Sciences and Physical Education - UDC

Oleiros, A Coruña, 1517, Spain

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Eliseo Iglesias-Soler, PhD

    Universidade da Coruña

    PRINCIPAL INVESTIGATOR
  • María Rúa-Alonso, PhD

    Universidade da Coruña

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliseo Iglesias-Soler, PhD

CONTACT

María Rúa-Alonso, PhD

CONTACT

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

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
6 months after finishing the whole project

Locations