Effects of Resistance Training Intensity on Cardiovascular Parameters of Hypertensive Women

NCT ID: NCT06538454

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-23
• Study Completion Date: 2025-09-30

Brief Summary

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

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.

Conditions

Arterial Hypertension; Postmenopausal; Menorrhagia; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Resistance training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Resistance training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Strength training

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leonardo da Silva Gonçalves

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laboratório de Fisiologia do Exercício e Metabolismo

Ribeirão Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Leonardo S Gonçalves

Role: CONTACT

leonardo.edfisica@usp.br

16981806105

Facility Contacts

Leonardo S Gonçalves

Role: primary

leonardo.edfisica@usp.br

16981806105

Other Identifiers

LOADPMW5065

Identifier Type: -

Identifier Source: org_study_id