An interventional study of Resistance training in Arterial Hypertension, Postmenopausal; Menorrhagia and Cardiovascular Diseases, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-05.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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:
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:
In the chronic experiment:
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.
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This study's planned enrollment of 24 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
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Exclusion Criteria:
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 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.
Also known as: Strength training
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.
Time frame: Up to end of study data collection (both stages), i.e, assesed up to 1 year
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to end of study data collection (both stages), i.e, assesed up to 1 year
Plan to share: No
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