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临床试验/NCT07377383
NCT07377383
招募中
不适用

Cardiometabolic Adaptations to Resistance and Endurance Exercise: Effects of Effort Configuration in Concurrent Training for Postmenopausal Women

Universidade da Coruña1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月5日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Blood pressure

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
46 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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).

干预措施: Concurrent Training Program (Other)

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).

干预措施: Concurrent Training Program (Other)

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).

干预措施: Concurrent Training Program (Other)

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).

干预措施: Concurrent Training Program (Other)

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).

干预措施: Concurrent Training Program (Other)

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).

干预措施: Concurrent Training Program (Other)

结局指标

主要结局

Blood pressure

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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).

次要结局

  • 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))
  • Cardiorespiratory Fitness (Peak oxygen uptake)(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)(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(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(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(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(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(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(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(Baseline (week 0), partial evaluation 1 (week 6), partial evaluation 2 (week 12), partial evaluation 3 (week 18), and post-intervention evaluation (week 24))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eliseo Iglesias Soler

Principal Investigator

Universidade da Coruña

研究点 (1)

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