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

Hypertension Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05544357
• Other study ID #: PID2021-124277OB-I00
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Universidade da Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 on cardiovascular changes, we aim to contrast acute and chronic changes to resistance training programs in normotensive and hypertensive postmenopausal women.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Postmenopausal

Intervention

Other:
• Short set configuration resistance training
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
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

Locations

Country	Name	City	State
Spain	Faculty of Sport Sciences and Physical Education	Bastiagueiro	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
Universidade da Coruña	Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	25 minutes
Primary	Blood pressure	Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg	25 minutes
Primary	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	25 minutes
Primary	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	25 minutes
Primary	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	25 minutes
Primary	Resting metabolic rate	It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day	60 minutes
Primary	Arterial stiffness	It will be assessed by finger-toe pulse wave velocity method. Units: m/s	15 minutes
Primary	Bone mineral density	It will be obtained by a Ultrasound Bone Densitometer. Units: g/cm	10 minutes
Secondary	Skeletal muscle mass	Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass	10 minutes
Secondary	Fat mass	Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass	10 minutes
Secondary	Body mass	Measured in kg	10 minutes
Secondary	Body mass index	Measured in kg/m^2	2 minutes
Secondary	Height	Measured in m	10 minutes
Secondary	Muscle thickness	Measured with an ultrasound device. Units: mm	20 minutes
Secondary	Torque-velocity relationship	Relationship between torque (N/m) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer	60 minutes
Secondary	Power-velocity relationship	Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer	60 minutes
Secondary	Maximum isometric torque	Maximum torque recorded at fixed angular position. It will be measured with an isokinetic dynamometer. Units: N/m	60 minutes
Secondary	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	5 minutes