Cardiovascular Adaptations to Resistance Exercise: Effect of Set Configuration on Postmenopausal Women (CARE)
Cardiovascular Adaptations to Resistance Exercise: Effects of Set Configuration on Normotensive and Hypertensive Postmenopausal Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
A Coruña
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Bastiagueiro, A Coruña, Spain, 15179
- Faculty of Sport Sciences and Physical Education
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance training with short set configuration performed by normotensive postmenopausal women
Normotensive 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
|
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
|
|
Experimental: Resistance training with short set configuration performed by hypertensive postmenopausal women
Hypertensive 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
|
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
|
|
Experimental: Resistance training with long set configuration performed by normotensive postmenopausal women
Normotensive 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
|
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
|
|
Experimental: Resistance training with long set configuration performed by hypertensive postmenopausal women
Hypertensive 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
25 minutes
|
|
Blood pressure
Time Frame: 25 minutes
|
Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor.
Units: mmHg
|
25 minutes
|
|
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
|
25 minutes
|
|
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
|
25 minutes
|
|
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
|
25 minutes
|
|
Resting metabolic rate
Time Frame: 60 minutes
|
It will be obtained by measuring oxygen consumption at rest.
Units: kcal/·day
|
60 minutes
|
|
Arterial stiffness
Time Frame: 15 minutes
|
It will be assessed by finger-toe pulse wave velocity method.
Units: m/s
|
15 minutes
|
|
Bone mineral density
Time Frame: 10 minutes
|
It will be obtained by a Ultrasound Bone Densitometer.
Units: g/cm
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skeletal muscle mass
Time Frame: 10 minutes
|
Estimated by Bioelectrical impedance analysis.
Units: kg and percentage of body mass
|
10 minutes
|
|
Fat mass
Time Frame: 10 minutes
|
Estimated by Bioelectrical impedance analysis.
Units: kg and percentage of body mass
|
10 minutes
|
|
Body mass
Time Frame: 10 minutes
|
Measured in kg
|
10 minutes
|
|
Height
Time Frame: 10 minutes
|
Measured in m
|
10 minutes
|
|
Muscle thickness
Time Frame: 20 minutes
|
Measured with an ultrasound device.
Units: mm
|
20 minutes
|
|
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
|
60 minutes
|
|
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
|
60 minutes
|
|
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
|
60 minutes
|
|
Lipid profile to determine cardiovascular risk
Time Frame: 5 minutes
|
|
5 minutes
|
|
Body mass index
Time Frame: 2 minutes
|
Measured in kg/m^2
|
2 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eliseo Iglesias-Soler, PhD, University of A Coruna
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID2021-124277OB-I00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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