Effects of Resistance Training Intensity on Cardiovascular Parameters of Hypertensive Women

NCT06538454 | Recruiting

• 1 other identifier: LOADPMW5065
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Arterial Hypertension; Postmenopausal; Menorrhagia; Cardiovascular Diseases

Keywords

Resistance training; Intensity; Blood pressure; Heart rate variability; Endothelial function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Values of heart rate variability (ms)

  Up to end of study data collection (both stages), i.e, assesed up to 1 year

• Endothelial function (Flow mediated dilatation %)

  Up to end of chronic experiment (baseline and post-intervention values), assesed up to 1 year

• Salivary concentrations of nitric oxide (mmol/L)

  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)

  Up to end of study data collection (both stages), i.e, assesed up to 1 year

• Affectivity (scale from -5 to +5)

  Up to end of study data collection (both stages), i.e, assesed up to 1 year

Study Arms (2)

80% of 1 repetition maximum

ACTIVE COMPARATOR

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

60% of 1 repetition maximum

ACTIVE COMPARATOR

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

Interventions

Resistance training 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.

Also known as: Strength training

60% of 1 repetition maximum; 80% of 1 repetition maximum

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Laboratório de Fisiologia do Exercício e Metabolismo

Ribeirão Preto, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension; Menorrhagia; Cardiovascular Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Vascular Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Leonardo S Gonçalves

CONTACT

16981806105; leonardo.edfisica@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Exercise training studies cannot blind therapists or participants to the intervention or exercise administred. Our study will blind the statistical analysis because we will code the data to avoid knowledge about the intervention performed and who was the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be conducted in two stages: one acute and one chronic. In the acute stage, with a crossover design, the subjects will be perform in a random order two resistance training sessions with different intensity. Following this stage, the subjects will be randomized in one of two groups of intensity in a randomized clinical trial design with 10 week of intervention (resistance training).

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 5, 2024
• Study Start: July 23, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)