Cardiometabolic Adaptations to Concurrent Training: Effect of Effort Configuration on Postmenopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age46-65
SponsorUniversidade da Coruña
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Concurrent Training Program
Other interventionAll 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.
Treatment groups
60 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Short Set Configuration (4S) + Moderate-Intensity Continuous Training (MICT)Experimental treatment 1 intervention
Group B: Concurrent Training: Long Set Configuration (9S) + Moderate-Intensity Continuous Training (MICT)Experimental treatment 1 intervention
Group C: Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 30% TTE (AIT30)Experimental treatment 1 intervention
Group D: Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 30% TTE (AIT30)Experimental treatment 1 intervention
Group E: Concurrent Training: Short Set Configuration (4S) + Aerobic Interval Training, 75% TTE (AIT75)Experimental treatment 1 intervention
Group F: Concurrent Training: Long Set Configuration (9S) + Aerobic Interval Training, 75% TTE (AIT75)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood pressure
Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg
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)2
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
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)3
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
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)4
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
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)Secondary outcomes
1
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.
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)2
Dietary Habits
Assessed using the Short Diet Quality Screener (SDQS) questionnaire to evaluate dietary patterns and quality.
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)3
Body Composition: Body Fat Percentage
Body Fat Percentage measured in percent using multifrequency bioimpedance (Bodystat Quadscan 4000, Quadscan, United Kingdom).
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)4
Bone Mineral Density
Estimated bone mineral density assessed using ultrasound densitometry (Sonost 3000, Osteosys Corp., Korea).
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)Other outcomes
1
Health Status
Assessed by a medical professional during the preliminary consultation using standard clinical evaluation procedures.
Time frame
Baseline (week 0)2
Cardiovascular Risk Factors
Stratified during the preliminary medical consultation. Participants will be categorized into standardized cardiovascular risk levels (for example, low risk, moderate risk, or high risk) according to established clinical criteria that combine blood pressure category (e.g., high-normal, Grade 1 hypertension, Grade 2 hypertension) with the number of additional risk factors and presence of organ damage or prior cardiovascular disease; higher categories indicate greater cardiovascular risk.
Time frame
Baseline (week 0)3
Absolute and Relative Contraindications for Exercise
Assessed by a medical professional during the preliminary consultation using established clinical guidelines.
Time frame
Baseline (week 0)4
Resting Electrocardiogram Parameters
Measured in standard clinical units during a resting electrocardiogram.
Time frame
Baseline (week 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade da Coruña
Lead sponsor
Ministerio de Ciencia e Innovación, Spain
Collaborator
Source ClinicalTrials.gov