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

Primary Purpose

Postmenopausal, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Short set configuration resistance training
Long set configuration resistance training
Sponsored by
Universidade da Coruña
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal focused on measuring resistance training, postmenopausal women, cardiovascular responses, cardiovascular adaptations

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Five years 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

Sites / Locations

  • Faculty of Sport Sciences and Physical EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Resistance training with short set configuration performed by normotensive postmenopausal women

Resistance training with short set configuration performed by hypertensive postmenopausal women

Resistance training with long set configuration performed by normotensive postmenopausal women

Resistance training with long set configuration performed by hypertensive postmenopausal women

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
Blood pressure
Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg
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
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
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
Resting metabolic rate
It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day
Arterial stiffness
It will be assessed by finger-toe pulse wave velocity method. Units: m/s
Bone mineral density
It will be obtained by a Ultrasound Bone Densitometer. Units: g/cm

Secondary Outcome Measures

Skeletal muscle mass
Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass
Fat mass
Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass
Body mass
Measured in kg
Body mass index
Measured in kg/m^2
Height
Measured in m
Muscle thickness
Measured with an ultrasound device. Units: mm
Torque-velocity relationship
Relationship between torque (N/m) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer
Power-velocity relationship
Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer
Maximum isometric torque
Maximum torque recorded at fixed angular position. It will be measured with an isokinetic dynamometer. Units: N/m
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

Full Information

First Posted
September 10, 2022
Last Updated
September 28, 2023
Sponsor
Universidade da Coruña
Collaborators
Ministerio de Ciencia e Innovación, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05544357
Brief Title
Cardiovascular Adaptations to Resistance Exercise: Effect of Set Configuration on Postmenopausal Women
Acronym
CARE
Official Title
Cardiovascular Adaptations to Resistance Exercise: Effects of Set Configuration on Normotensive and Hypertensive Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Coruña
Collaborators
Ministerio de Ciencia e Innovación, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 on cardiovascular changes, we aim to contrast acute and chronic changes to resistance training programs in normotensive and hypertensive postmenopausal women.
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 (20 normotensive and 20 hypertensive) will be randomly assigned 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal, Hypertension
Keywords
resistance training, postmenopausal women, cardiovascular responses, cardiovascular adaptations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance training with short set configuration performed by normotensive postmenopausal women
Arm Type
Experimental
Arm Description
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
Arm Title
Resistance training with short set configuration performed by hypertensive postmenopausal women
Arm Type
Experimental
Arm Description
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
Arm Title
Resistance training with long set configuration performed by normotensive postmenopausal women
Arm Type
Experimental
Arm Description
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
Arm Title
Resistance training with long set configuration performed by hypertensive postmenopausal women
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Short set configuration resistance training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Long set configuration resistance training
Intervention Description
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 Outcome Measure Information:
Title
Baroreflex sensitivity
Description
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
Time Frame
25 minutes
Title
Blood pressure
Description
Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg
Time Frame
25 minutes
Title
Heart rate variability in time domain
Description
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
Time Frame
25 minutes
Title
Heart rate variability in frequency domain
Description
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
Time Frame
25 minutes
Title
Blood pressure variability
Description
It will be calculated by spectral analysis of beat-to-beat blood pressure recordings obtained by a photoplethysmography sensor. Units: mmHg2/Hz
Time Frame
25 minutes
Title
Resting metabolic rate
Description
It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day
Time Frame
60 minutes
Title
Arterial stiffness
Description
It will be assessed by finger-toe pulse wave velocity method. Units: m/s
Time Frame
15 minutes
Title
Bone mineral density
Description
It will be obtained by a Ultrasound Bone Densitometer. Units: g/cm
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Skeletal muscle mass
Description
Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass
Time Frame
10 minutes
Title
Fat mass
Description
Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass
Time Frame
10 minutes
Title
Body mass
Description
Measured in kg
Time Frame
10 minutes
Title
Body mass index
Description
Measured in kg/m^2
Time Frame
2 minutes
Title
Height
Description
Measured in m
Time Frame
10 minutes
Title
Muscle thickness
Description
Measured with an ultrasound device. Units: mm
Time Frame
20 minutes
Title
Torque-velocity relationship
Description
Relationship between torque (N/m) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer
Time Frame
60 minutes
Title
Power-velocity relationship
Description
Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer
Time Frame
60 minutes
Title
Maximum isometric torque
Description
Maximum torque recorded at fixed angular position. It will be measured with an isokinetic dynamometer. Units: N/m
Time Frame
60 minutes
Title
Lipid profile to determine cardiovascular risk
Description
Total Cholesterol in mg/dL High-Density Lipoprotein in mg/dL Triglycerides in mg/dL Calculated Low-Density Lipoprotein in mg/dL
Time Frame
5 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Five years 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliseo Iglesias-Soler, PhD
Phone
+3498167000
Ext
4061
Email
eliseo.iglesias.soler@udc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliseo Iglesias-Soler, PhD
Organizational Affiliation
University of A Coruna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Sport Sciences and Physical Education
City
Bastiagueiro
State/Province
A Coruña
ZIP/Postal Code
15179
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eliseo Iglesias-Soler, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
6 months after finishing the whole project

Learn more about this trial

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

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