Effects of Resistance Training Intensity on Cardiovascular Parameters of Hypertensive Women

Acute and Chronic Effects of Resistance Training Intensity on Cardiovascular Parameters of Postmenopausal Women With Systemic Arterial Hypertension

The goal of this clinical trial is to understand about the effects of resistance training (RT) intensity on cardiovascular parameters in postmenopausal women with systemic arterial hypertension (SAH). The main research questions are:

• Does the intensity of RT impact blood pressure (BP) in postmenopausal women with SAH?
• How does RT intensity affect heart rate (HR) and their variability (HRV), endothelial function (EF), and nitric oxide (NO) biomarker synthesis in this population?
• What are the effects of RT intensity on affectivity and rate of perceived exertion (RPE)?

Researchers will compare two different intensities of RT (60% of the load for 1 repetition maximum [1RM] and 80% of 1RM) to determine their effects on the mentioned cardiovascular and perceptual parameters.

Participants will:

In the acute experiment:

• Perform the same RT session in a crossover design, training with 60% of 1RM in one condition and 80% of 1RM in another condition
• Have BP, HR, and HRV measured before, immediately after, and for one hour post-session
• Report affectivity before each session and at the end, along with RPE

In the chronic experiment:

• Be randomized into two groups: one training with 60% of 1RM and the other with 80% of 1RM
• Undergo a 10-week intervention period with evaluations before, during, and after the intervention
• Have BP, HR, affective responses, and RPE measured at multiple time points
• Have EF, HRV, and salivary concentrations of NO biomarkers assessed before and after the intervention

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Arterial Hypertension; Postmenopausal; Menorrhagia
• Intervention / Treatment: Behavioral: Resistance training

Detailed Description

Physical training has been recommended as a non-pharmacological therapeutic strategy that can promote improvements in blood pressure levels in patients with systemic arterial hypertension (SAH). Resistance training (RT) has emerged due to the various benefits it promotes, including reducing blood pressure (BP) in this population, as improvements in heart rate variability (HRV) and endothelial function (EF). Guidelines suggest an intensity between 50% and 80% of 1 repetition maximum (1RM) in RT, reflecting a range of maximum repetitions between 9 and 26. However, there is a lack of studies that have made a direct comparison of the effect of different intensities in cardiovascular parameters of these patients. Therefore, the objective of this study will be to evaluate, acutely and chronically, the effect of RT intensity on BP, heart rate (HR), HRV, endothelial function, salivary concentrations of nitric oxide (NO) biomarker synthesis, also affectivity and rate of perceived exertion (RPE) of postmenopausal women with SAH. The study will be conducted in two stages, with two experiments: one acute and one chronic. In the acute experiment, with a crossover design, participants will perform the same RT session (with the order of these sessions being random), but in one condition they will train with 60% of 1RM and in another with 80% of 1RM. BP, HR and HRV will be measured before, at the end and for one hour after the session (hypotensive effect of the exercise). Affectivity will be measured before each test and at the end together with PSE. In the chronic study, participants will be randomized to one group that will train with 60% of 1RM and another group that will train with 80% of 1RM. Before, during and after the intervention, which will last 10 weeks, participants will be evaluated for BP, HR, affective responses and RPE, with EF, HRV and salivary concentrations of NO biomarkers measured before and after the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonardo S Gonçalves; Phone Number: 16981806105; Email: leonardo.edfisica@usp.br

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil
      • Recruiting
      • Laboratório de Fisiologia do Exercício e Metabolismo
      • Contact: Leonardo S Gonçalves; Phone Number: 16981806105; Email: leonardo.edfisica@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women with 50 to 65 old years;
• Postmenopausal diagnosis (amenorrhea for 12 months or more);
• Previous diagnosis of hypertension and treat with medications;
• Physically inactive.

Exclusion Criteria:

• History of other cardiovascular problems (heart failure, heart attack, stroke, etc);
• Grade II obesity (BMI ≥ 35 kg/m²);
• Medications (beta-blockers and/or non-dihydropyridine calcium channel blockers);
• Systolic blood pressure at rest above 160 mmHg and/or dyastolic blood presure above 105 mmHg;
• Unable to perform resistance exercise due to musculoskeletal or cognitive reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 80% of 1 repetition maximum; The recent guideliness suggest a resistance training intensity for this population between 50 and 80% of 1 repetition maximum (1RM), i.e, this group will training in accordance with the recommendations. These group will be training with 80% 1RM, performining 8-10 repetitions per set.	Behavioral: Resistance training; The exercises will be the same in both stages: squat, bench press, stiff, rowing, hip thrust and shoulder press. Futhermore, the rest interval (2 minutes) and the exercise order (alterning upper and lower limbs) also will be the same in the stages. In the chronic experiment, the resistance training will be carried for 10 weeks with 2 weekly sessions in alternate days. The sets in both groups will be carried close to muscle failure. The difference between groups is the intensity, who reflects the repetition zone. The 80%1RM group will be perform 8-10 repetitions per set, while the 60%1RM group will be perform 18-20 repetitions.; Other Names: Strength training
Active Comparator: 60% of 1 repetition maximum; The recent guideliness suggest a resistance training intensity for this population between 50 and 80% of 1 repetition maximum (1RM), i.e, this group will training in accordance with the recommendations. These group will be training with 60% 1RM, performining 18-20 repetitions per set.	Behavioral: Resistance training; The exercises will be the same in both stages: squat, bench press, stiff, rowing, hip thrust and shoulder press. Futhermore, the rest interval (2 minutes) and the exercise order (alterning upper and lower limbs) also will be the same in the stages. In the chronic experiment, the resistance training will be carried for 10 weeks with 2 weekly sessions in alternate days. The sets in both groups will be carried close to muscle failure. The difference between groups is the intensity, who reflects the repetition zone. The 80%1RM group will be perform 8-10 repetitions per set, while the 60%1RM group will be perform 18-20 repetitions.; Other Names: Strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Values of systolic and diastolic blood pressure (mmHg)	This measurement will be assessed in both stages. In the acute phase, this measurement will be performed on the participant before, after and up to one hour after the end of the training session. In the chronic phase, this measure will be performed in participant after a rest in a quiet room with temperature controlled before (baseline) and after 10 week of intervention. Futhermore, along the intervention these measure will be performed before and after training sessions.	Up to end of study data collection (both stages), i.e, assesed up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Values of heart rate variability (ms)	This measurement will be assessed in both stages. In the acute phase, this measurement will be performed on the participant before, after and up to one hour after the end of the training session. In the chronic phase, this measure will be performed in participant after a rest in a quiet room with temperature controlled before (baseline) and after 10 week of intervention. Futhermore, along the intervention these measure will be performed before and after training sessions.	Up to end of study data collection (both stages), i.e, assesed up to 1 year
Endothelial function (Flow mediated dilatation %)	This measurement will be performed before acute experiment (baseline) and after 10 week intervention (end of chronic experiment) in a quiet room with controlled temperature.	Up to end of chronic experiment (baseline and post-intervention values), assesed up to 1 year
Salivary concentrations of nitric oxide (mmol/L)	This measurement will be performed before acute experiment (baseline) and after 10 week intervention (end of chronic experiment).	Up to end of chronic experiment (baseline and post-intervention values), i.e, assesed up to 1 year
Rate of perceived exertion (scale from 1 to 10)	This measurement will be performed after all training sessions, i.e, in both stages. The participants will be remembered the meanings of the scale.	Up to end of study data collection (both stages), i.e, assesed up to 1 year
Affectivity (scale from -5 to +5)	This measurement will be performed before and after all training sessions, i.e, in both stages. The participants will be remembered the meanings of the scale.	Up to end of study data collection (both stages), i.e, assesed up to 1 year

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Endothelial function; Blood pressure; Heart rate variability; Resistance training; Intensity
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hypertension; Cardiovascular Diseases; Menorrhagia
• Other Study ID Numbers: LOADPMW5065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No