Arterial HypertensionNCT06538454
Effects of Resistance Training Intensity on Cardiovascular Parameters of Hypertensive Women
A study testing Resistance training in people with Arterial Hypertension and Postmenopausal; Menorrhagia, run by University of Sao Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Arterial Hypertension, Postmenopausal; Menorrhagia, Cardiovascular Diseases
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jul 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Fisiologia do Exercício e Metabolismo
Ribeirão Preto, São Paulo
Leonardo S Gonçalves, 16981806105, leonardo.edfisica@usp.br
About this study
Official title: 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)?
Read more
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
Read the 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.
- Being tested
- Resistance training
- Keywords
- Resistance training, Intensity, Blood pressure, Heart rate variability, Endothelial function
- Medical subject headings
- Hypertension, Menorrhagia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Also called Strength 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to end of study data collection (both stages), i.e, assesed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start23 Jul 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo da Silva Gonçalves, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538454
- Sponsor's protocol ID
- LOADPMW5065
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Resistance Training Intensity on Cardiovascular Parameters of Postmenopausal Women With Systemic Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06538454
- Acronym / sponsor ID
- LOADPMW5065
- Keywords
- Resistance training, Intensity, Blood pressure, Heart rate variability, Endothelial function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 80% of 1 repetition maximum | Active comparator | Behavioral: Resistance trainingThe 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. |
| 60% of 1 repetition maximum | Active comparator | Behavioral: Resistance trainingThe 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingAlso: Strength trainingThe 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. | Behavioural | 60% of 1 repetition maximum, 80% of 1 repetition maximum |
Primary outcome
Values of systolic and diastolic blood pressure (mmHg)
Time frame: Up to end of study data collection (both stages), i.e, assesed up to 1 year
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.
5 secondary outcomes
Values of heart rate variability (ms)
Time frame: Up to end of study data collection (both stages), i.e, assesed up to 1 year
Endothelial function (Flow mediated dilatation %)
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)
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)
Time frame: Up to end of study data collection (both stages), i.e, assesed up to 1 year
Affectivity (scale from -5 to +5)
Time frame: Up to end of study data collection (both stages), i.e, assesed up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Arterial Hypertension and Postmenopausal; Menorrhagia, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo S Gonçalves (16981806105, leonardo.edfisica@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of systolic and diastolic blood pressure (mmHg) (time frame: Up to end of study data collection (both stages), i.e, assesed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.