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PostmenopausalCARENCT05544357

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

A study testing Short set configuration resistance training and Long set configuration resistance training in people with Postmenopausal and Hypertension, run by Universidade da Coruña at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 50 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postmenopausal, Hypertension
What is being tested?
Short set configuration resistance training and Long set configuration resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
3 Feb 2023to 26 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Faculty of Sport Sciences and Physical Education

    Bastiagueiro, A Coruña, 15179

Other trials in Spain

About this study

Official title: Cardiovascular Adaptations to Resistance Exercise: Effects of Set Configuration on Normotensive and Hypertensive 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.

Read the detailed description

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.

Being tested
Short set configuration resistance training, Long set configuration resistance training
Keywords
resistance training, postmenopausal women, cardiovascular responses, cardiovascular adaptations
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Short set configuration resistance trainingOther

    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 trainingOther

    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

Study groups in NCT05544357
Study groupRoleWhat they receive
Resistance training with short set configuration performed by normotensive postmenopausal womenExperimentalNormotensive postmenopausal women performing 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
Receives: Other: Short set configuration resistance training
Resistance training with short set configuration performed by hypertensive postmenopausal womenExperimentalHypertensive postmenopausal women performing 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
Receives: Other: Short set configuration resistance training
Resistance training with long set configuration performed by normotensive postmenopausal womenExperimentalNormotensive postmenopausal women performing resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a long set configuration protocol
Receives: Other: Long set configuration resistance training
Resistance training with long set configuration performed by hypertensive postmenopausal womenExperimentalHypertensive postmenopausal women performing resistance training protocol with the highest cardiovascular stress identified in the first study of the project. It can be expected to be a long set configuration protocol
Receives: Other: Long set configuration resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 25 minutes

  2. Blood pressure

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

    Measured: 25 minutes

  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

    Measured: 25 minutes

  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

    Measured: 25 minutes

  5. 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

    Measured: 25 minutes

  6. Resting metabolic rate

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

    Measured: 60 minutes

  7. Arterial stiffness

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

    Measured: 15 minutes

  8. Bone mineral density

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

    Measured: 10 minutes

Secondary outcomes (10)
  1. Skeletal muscle mass

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

    Measured: 10 minutes

  2. Fat mass

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

    Measured: 10 minutes

  3. Body mass

    Measured in kg

    Measured: 10 minutes

  4. Body mass index

    Measured in kg/m^2

    Measured: 2 minutes

  5. Height

    Measured in m

    Measured: 10 minutes

  6. Muscle thickness

    Measured with an ultrasound device. Units: mm

    Measured: 20 minutes

  7. Torque-velocity relationship

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

    Measured: 60 minutes

  8. Power-velocity relationship

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

    Measured: 60 minutes

  9. Maximum isometric torque

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

    Measured: 60 minutes

  10. Lipid profile to determine cardiovascular risk

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

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start3 Feb 2023
  3. Primary completion26 Sep 2025
  4. Study completion26 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544357
Sponsor's protocol ID
PID2021-124277OB-I00
Acronym
CARE
Status last verified
Sep 2025
First submitted
10 Sep 2022
Last updated
1 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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 (https://zenodo.org/communities/udc/?page=1\&size=20\&size=20).

Publications

  • Iglesias-Soler E, Farinas J, Rua-Alonso M, Rial-Vazquez J, Nine I, Revuelta-Lera B. Shorter Set Configurations Attenuate Performance Loss and Lactatemia During Resistance Training in Postmenopausal Women: A Randomized Crossover Trial (CARE Project). J Strength Cond Res. 2026 Feb 1;40(2):e180-e188. doi: 10.1519/JSC.0000000000005301. Epub 2025 Dec 5.

    PubMed 41369549
  • Rial-Vazquez J, Rua-Alonso M, Enriquez-Gonzalez MG, Nine I, Rivera-Mejia SL, Revuelta-Lera B, Farinas J, Iglesias-Soler E. Cardiovascular adaptations to resistance training with different set configurations in postmenopausal women: a study protocol for a randomised controlled trial (CARE project). BMJ Open Sport Exerc Med. 2025 Nov 28;11(4):e003052. doi: 10.1136/bmjsem-2025-003052. eCollection 2025.

    PubMed 41334240
  • Nine I, Padron-Cabo A, Carballeira E, Rial-Vazquez J, Rua-Alonso M, Farinas J, Giraldez-Garcia M, Iglesias-Soler E. Acute cardiovascular responses of postmenopausal women to resistance training sessions differing in set configuration: A study protocol for a crossover trial. PLoS One. 2024 Oct 14;19(10):e0311524. doi: 10.1371/journal.pone.0311524. eCollection 2024.

    PubMed 39401188
  • Bohn L, Rial-Vazquez J, Nine I, Rua-Alonso M, Farinas J, Giraldez-Garcia MA, Mota J, Iglesias-Soler E. Arterial stiffness assessment by pulse wave velocity in postmenopausal women: comparison between noninvasive devices. Menopause. 2024 Aug 1;31(8):709-715. doi: 10.1097/GME.0000000000002383. Epub 2024 Jun 25.

    PubMed 38916283

Questions about this trial

What is this clinical trial studying?

A study testing Short set configuration resistance training and Long set configuration resistance training in people with Postmenopausal and Hypertension, run by Universidade da Coruña at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baroreflex sensitivity (time frame: 25 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05544357, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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