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Completed

NCT Number: NCT05544357

Cardiovascular Adaptations to Resistance Exercise: Effect of Set Configuration on Postmenopausal Women

The main purpose of this project is to analyze the effect of set configuration of resistance exercise on cardiovascular responses and adaptations of postmenopausal women. Additionally, since previous studies have shown that individual´s blood pressure level can influence on the impact of resistance training programs on cardiovascular changes, we aim to contrast acute and chronic changes to resistance training programs in normotensive and hypertensive postmenopausal women.

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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sport Sciences and Physical Education

Bastiagueiro, A Coruña, 15179, Spain

About this study

Menopause causes hormonal changes that affect to acute and chronic physiological responses to exercise of postmenopausal women. In this regard, studies about the cardiovascular responses to resistance training in women are scarce, being particularly relevant to identify those load parameters that modulate these adaptations. Previous studies have identified that set configuration of muscular exercise influence on cardiovascular stress, albeit these results have been mainly obtained in healthy young male subjects.

The project is divided into two studies. The first one is devoted to contrast the acute effect of three resistance training sessions with the same volume, intensity, length a work-to-rest ratio, but differing in set configuration. Thus, a sample of 60 postmenopausal women (30 normotensive and 30 hypotensive) will be recruited in local sport facilities in order to carry out in a randomized order three experimental sessions and a control session. Before and after each session hemodynamic (systolic, diastolic and mean blood pressure), cardiac performance (heart rate, cardiac output, stroke volume among others), cardiac and vascular autonomic modulation (hear rate and blood pressure variability), baroreflex effectiveness (baroreflex sensitivity), neuromuscular fatigue, arterial stiffness and metabolic (lactate concentrations) responses and resting energy expenditure (oxygen consumption) will be evaluated. This first analysis will allow us to identify the two set configurations with the highest and the lowest cardiovascular stress respectively, being these exercise structures used in the second study, in which the effect of 12 weeks resistance training programs differing in set configuration will be contrasted. To do this, a sample of 40 postmenopausal women will be randomly assigned to a control group and to two resistance training programs (higher and lower set configuration respectively) which be carried out throughout 12 weeks with a frequency of 2 session per week. Training loads will be readjusted every four weeks. Before and after the training programs and after a 4 weeks follow-up period the following components will be evaluated: body composition by bioimpedance, muscular thickness by echography, neuromuscular performance (isokinetic torque-velocity and power-velocity relationship), resting metabolic rate by indirect calorimetry, foot bone mineral density, beat-to-beat blood pressure by photoplethysmography, cardiac performance by impedance cardiography , cardiac autonomic modulation by heart rate variability analysis, baroreflex sensitivity analysis, sympathetic vasomotor tone (blood pressure variability) and arterial stiffness. This project will provide useful information for optimizing the resistance exercise prescription for postmenopausal women by identifying exercise structures that potentially allow to preserve physiological adaptations and at the same time to blunt the acute cardiovascular stress.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • One year since menopause
  • Physically active (150-300 minutes a week of moderate physical activity or at least 75 minutes a week of vigorous physical activity)
  • No more than 3 cardiovascular risk factors
  • Asymptomatic and without cardiovascular (except hypertension), metabolic or renal disease
  • Hypertensive women should be diagnosed with grade 1 hypertension that must be well controlled by one drug and with low or moderate cardiovascular risk.

Exclusion criteria

  • Having grade 2 or 3 hypertension
  • Participants with hypertension and taking more than one drug for controlling hypertension or by a drug that can interfere cardiovascular responses to exercise
  • To be or have been receiving hormonal replacement therapy
  • To show hypertensive response to exercise

Treatment and study plan

Short set configuration resistance training

Other

Resistance training protocol with the lowest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol

Long set configuration resistance training

Other

Resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a short set configuration protocol

Primary outcomes

  1. Baroreflex sensitivity

    Time frame: 25 minutes

    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

  2. Blood pressure

    Time frame: 25 minutes

    Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg

  3. Heart rate variability in time domain

    Time frame: 25 minutes

    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

  4. Heart rate variability in frequency domain

    Time frame: 25 minutes

    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

  5. Blood pressure variability

    Time frame: 25 minutes

    It will be calculated by spectral analysis of beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor. Units: mmHg2/Hz

  6. Resting metabolic rate

    Time frame: 60 minutes

    It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day

  7. Arterial stiffness

    Time frame: 15 minutes

    It will be assessed by finger-toe pulse wave velocity method. Units: m/s

  8. Bone mineral density

    Time frame: 10 minutes

    It will be obtained by a Ultrasound Bone Densitometer. Units: g/cm

Secondary outcomes

  1. Skeletal muscle mass

    Time frame: 10 minutes

    Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass

  2. Fat mass

    Time frame: 10 minutes

    Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass

  3. Body mass

    Time frame: 10 minutes

    Measured in kg

  4. Body mass index

    Time frame: 2 minutes

    Measured in kg/m^2

  5. Height

    Time frame: 10 minutes

    Measured in m

  6. Muscle thickness

    Time frame: 20 minutes

    Measured with an ultrasound device. Units: mm

  7. Torque-velocity relationship

    Time frame: 60 minutes

    Relationship between torque (N/m) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer

  8. Power-velocity relationship

    Time frame: 60 minutes

    Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer

  9. Maximum isometric torque

    Time frame: 60 minutes

    Maximum torque recorded at fixed angular position. It will be measured with an isokinetic dynamometer. Units: N/m

  10. Lipid profile to determine cardiovascular risk

    Time frame: 5 minutes

    • Total Cholesterol in mg/dL
    • High-Density Lipoprotein in mg/dL
    • Triglycerides in mg/dL
    • Calculated Low-Density Lipoprotein in mg/dL

Sponsors and collaborators

Lead sponsor

Universidade da Coruña

Other

Collaborators

  • Ministerio de Ciencia e Innovación, Spain

Registry information

Official study title

Cardiovascular Adaptations to Resistance Exercise: Effects of Set Configuration on Normotensive and Hypertensive Postmenopausal Women

Acronym: CARE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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