Cardiometabolic Adaptations to Concurrent Training: Effect of Effort Configuration on Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concurrent Training Program.
- Who it may be relevant to
- Registry conditions: Postmenopausal, Hypertension. Basic parameters: 46 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cardiometabolic Adaptations to Resistance and Endurance Exercise: Effects of Effort Configuration in Concurrent Training for Postmenopausal Women
Overview
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.
Interventions
- Other Concurrent Training Program
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
Primary outcome measures
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
- 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)]
Secondary outcome measures (12)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Faculty of Sport Sciences and Physical Education - UDC — Oleiros
Identifiers
NCT: NCT07377383 · PID2024-156481OB-I00