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

Study Overview
=================
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.

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

Conditions
-----------------
Postmenopausal, Hypertension

Intervention / Treatment
-----------------
* Other: Short set configuration resistance training
* Other: Long set configuration resistance training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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<br>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 | Other: Short set configuration resistance training<br>* 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<br>|
| Experimental: Resistance training with short set configuration performed by hypertensive postmenopausal women<br>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 | Other: Short set configuration resistance training<br>* 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<br>|
| Experimental: Resistance training with long set configuration performed by normotensive postmenopausal women<br>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 | Other: Long set configuration resistance training<br>* 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<br>|
| Experimental: Resistance training with long set configuration performed by hypertensive postmenopausal women<br>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 | Other: Long set configuration resistance training<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Blood pressure | Systolic, diastolic and mean blood pressure will be obtained by a photoplethysmography sensor. Units: mmHg | 25 minutes | 
| 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 | 
| 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 | 
| 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 | 
| Resting metabolic rate | It will be obtained by measuring oxygen consumption at rest. Units: kcal/·day | 60 minutes | 
| Arterial stiffness | It will be assessed by finger-toe pulse wave velocity method. Units: m/s | 15 minutes | 
| Bone mineral density | 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 | Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass | 10 minutes | 
| Fat mass | Estimated by Bioelectrical impedance analysis. Units: kg and percentage of body mass | 10 minutes | 
| Body mass | Measured in kg | 10 minutes | 
| Body mass index | Measured in kg/m^2 | 2 minutes | 
| Height | Measured in m | 10 minutes | 
| Muscle thickness | Measured with an ultrasound device. Units: mm | 20 minutes | 
| 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 | 
| Power-velocity relationship | Relationship betweenPower (W) and angular velocity (°/s). Obtained by performing maximum torque at specific velocities in an isokinetic dynamometer | 60 minutes | 
| Maximum isometric torque | 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 | Total Cholesterol in mg/dL High-Density Lipoprotein in mg/dL Triglycerides in mg/dL Calculated Low-Density Lipoprotein in mg/dL | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistance training, postmenopausal women, cardiovascular responses, cardiovascular adaptations