HypertensionNCT03529838
Hemodynamic and Salivary Responses of 12 Weeks of Training With Different Anti-hypertensive
A study testing Combined exercise in people with Hypertension and Menopause, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
Different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Hypertension, Menopause
- What is being tested?
- Combined exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2017to 1 Mar 2021
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 50 and 70 years;
- Be in the postmenopausal phase;
- Be able to practice physical exercise on treadmill and bodybuilding,
- Receive a release certificate for exercise practice;
- Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises;
- In the case of hypertensives: present stage 1 hypertension, according to the guidelines of the Brazilian Society of Hypertension (2010);
- In the case of hypertensive patients, undergo drug treatment with β-blockers or Angiotensin receptor blockers.
Who cannot join
- Present history of stroke or acute myocardial infarction;
- Smokers;
- Present diagnosis of Diabetes Mellitus or renal pathologies;
- Use of antihypertensive drugs from classes that were not selected for this project;
- Make use of hormonal therapies;
- Being uncompensated hypertensive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Responses and Salivary Markers of the Interaction of 12 Weeks of Training With Different Anti-hypertensive in Menopausal Women
Different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women.
Read the detailed description
Cardiovascular diseases are the leading causes of death and postmenopausal women. Physical exercise, in turn, is a strategy to reduce cardiovascular stress, by decreasing the blood pressure (BP) at rest and several risk factors associated with sedentary lifestyle, thus improving the quality and life expectancy of these women. However, different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women. The volunteers will do cardiovascular and biochemistry evaluations before and after the intervention.
- Conditions
- Hypertension, Menopause
- Being tested
- Combined exercise
- Keywords
- Combined Exercise, Ambulatorial Blood Pressure Monitoring, Blood analysis, Salivary analysis, Heart rate variability
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exerciseOther
The program consisted of 36 sessions of combined aerobic and resistance exercises training during 12 consecutive weeks. Each session lasted 60 minutes and consisted of 30 minutes of resistance exercise and 30 minutes of aerobic exercise. The resistance training was performed in two sets of 8 to 12 repetitions in five exercises of weight training (Based on 1 repetition maximum test - 1RM). The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between 65 and 75% of maximun heart rate measured in maximum incremental test. Every week the resistance load and aerobic intensity was readjusted by determined training zone (8 to 12 maximum repetitions) and heart rate predicted in the incremental respectively.
| Study group | Role | What they receive |
|---|---|---|
| No medication | Placebo comparator | Group of pre-hypertensive women with no medication who practiced 12 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months Receives: Other: Combined exercise |
| Angiotensin receptor blockers | Active comparator | Group of hypertensive women taking Angiotensin receptor blockers who practiced 12 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months Receives: Other: Combined exercise |
| Beta blockers | Active comparator | Group of hypertensive women taking Beta blockers who practiced 12 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months Receives: Other: Combined exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ambulatorial Blood Pressure
All volunteers were submitted to a 24-hour Blood Pressure (BP; systolic and diastolic measurements) assessment by Ambulatorial Blood Pressure Monitoring (ABPM) before and after 10 weeks of combined exercise training, with a minimum of 48 hours after the last training session. A device was used associated with a diary of examination to self-report of activities of daily living (sleep, work, food) or any event that could interfere abnormally with BP or device measurements. The device was always placed 7am and the measurements were made every 15 minutes from 7h to 23h and every 30 minutes from 23h to 7h. The monitoring was considered valid when it happened for a period of 24 hours. The following results were evaluated: systolic blood pressure; diastolic blood pressure, mean blood pressure and heart rate in awake, sleep and 24-hour periods. Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position.
Measured: Before and within 72 hours after 12 weeks of exercise training
Secondary outcomes (5)
Changes in Ambulatorial Blood Pressure Variability
Based on Ambulatorial Blood Pressure data, were calculated Blood Pressure Variability by: 24-hour standard deviation weighted by the time interval between consecutive readings; the mean diurnal and nocturnal deviations weighted for the duration of the daytime and nighttime interval; the average real variability weighted for the time interval between consecutive readings; the ambulatory arterial stiffness index calculated by the slope of the trend curve of the dispersion of pressure data; the morning surge that represents the dynamic daytime variation in morning pressure that tends to increase, being assessed from the point of least pressure during sleep in relation to the first two hours after waking; and nocturnal dipping, that represents the average percentage drop of sleep pressure in relation to wakefulness, and individuals with falls of 10% or more are considered dippers and below that are considered nom-dippers.
Measured: Before and within 72 hours after 12 weeks of exercise training
Changes in Heart Rate Variability
Heart Rate (HR) was recorded using a heart rate monitor in a beat-by-beat basis. HR was registered in a seat position for 20 min of rest. Prior to the HR Variability (HRV) analysis, the RR intervals (RRi) were visually inspected and filtered using a moving average filter. The HRV was analyzed in both time-, frequency- and nonlinear-domain. Being that for frequency-domain analysis, firstly the RRi series were interpolated at 4 Hz and then the signal linear trend component removal was performed using the smooth priors approach.
Measured: Before and within 72 hours after 12 weeks of exercise training
Changes in salivary oxidative stress
The salivary was collected after 12-hours fasting and the total antioxidant capacity was evaluated using the Ferric-Ability of Plasma (FRAP) methodology and calculated from the standard trolox curve. The activity of the enzyme superoxide dismutase (SOD) was determined based on the auto oxidation capacity of pyrogallol and catalase activity (CAT) by monitoring the consumption of hydrogen peroxide at 240 nm. Lipid peroxidation levels were determined by the TBARS method (thiobarbituric acid reactive substances), using as standard a curve of 1,1,3,3-tetraethoxypropane (TMP). The total protein concentration was obtained using bovine serum albumin (BSA) as standard. The amounts of nitric oxide (NO) were estimated by the determination of total nitrite by the Griess colorimetric method.
Measured: Before and within 72 hours after 12 weeks of exercise training
Changes of blood pressure reactivity
To evaluate reactivity of blood pressure under mental stress, the Stroop protocol will be used. The test consists of a video on a computer screen facing the volunteer that changes the image every 2 seconds. Then the volunteers should speak as quickly as possible the color of the letters present on the screen, and in each image there is dissonance between the background color, the color of the letters and the word formed (which is always the name of another color). Each minute of the test the blood pressure (systolic and diastolic) will be measured by auscultatory method. To evaluate the reactivity of blood pressure under physical stress will be used the Cold pressor test. The test consists of immersing the volunteers' right hand for 1 minute in water maintained at 4ºC. Blood pressure is then assessed in the left arm after 30 and 60 seconds of immersion and after 2 minutes after the end of immersion in water. The blood pressure measurements will be done by auscultatory method.
Measured: Before and within 72 hours after 12 weeks of exercise training
Changes of Biochemical markers on blood
Venous blood samples will be collected with 12 hours of fasting. After local asepsis, 10 ml of blood will be obtained at each collection through the puncture of the ulnar or radial ulnar vein, using a syringe and disposable needles. The blood samples will be deposited in test tubes containing ethylenediamine tetraacetic acid (EDTA) and dried tubes with separator gel for collection of serum. The samples will then be centrifuged at 2000 rpm for 15 minutes to separate plasma and serum aliquots and stored at -80 ° C for further biochemical analysis. Thus, the samples will be analyzed in the following variables: Lipid Profile, Superoxide Dismutase (SOD), Catalase (CAT), Thiobarbituric Acid (TBARS), Nitrite/nitrate (NOx-), Interleukin-6 (IL-6), Interleukin-10 IL-10), Interleukin-1 beta (IL-1b), Tumor Necrosis Factor alpha (TNFa), Creatine Kinase (CK), C-reactive protein (P-CR) and Adiponectin.
Measured: Before and within 72 hours after 12 weeks of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Mar 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2021
Why it stopped: Early interruption caused by the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 45 women taking different antihypertensives (15 no medications, 15 angiotensin receptor blockers and 15 beta blockers) for at least 6 months will be assessed at baseline and after 12 weeks of combined exercise training.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Moraes Mariano, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529838
- Sponsor's protocol ID
- 71285317.4.0000.5152
- Status last verified
- Mar 2022
- First submitted
- 8 May 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mariano IM, Amaral AL, V Carrijo VH, Costa JG, Rodrigues ML, Cunha TM, Puga GM. Different cardiovascular responses to exercise training in hypertensive women receiving beta-blockers or angiotensin receptor blockers: A pilot study. Clin Exp Hypertens. 2022 Jul 4;44(5):442-450. doi: 10.1080/10641963.2022.2065290. Epub 2022 Apr 23.
PubMed 35465803
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Responses and Salivary Markers of the Interaction of 12 Weeks of Training With Different Anti-hypertensive in Menopausal Women
- ClinicalTrials.gov ID
- NCT03529838
- Acronym / sponsor ID
- 71285317.4.0000.5152
- Conditions
- Hypertension, Menopause
- Keywords
- Combined Exercise, Ambulatorial Blood Pressure Monitoring, Blood analysis, Salivary analysis, Heart rate variability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early interruption caused by the COVID-19 pandemic.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 18 May 2018 (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.
Different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women.
Detailed description
Cardiovascular diseases are the leading causes of death and postmenopausal women. Physical exercise, in turn, is a strategy to reduce cardiovascular stress, by decreasing the blood pressure (BP) at rest and several risk factors associated with sedentary lifestyle, thus improving the quality and life expectancy of these women. However, different classes of antihypertensives may have different responses when associated with exercise. Thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women. The volunteers will do cardiovascular and biochemistry evaluations before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 45 women taking different antihypertensives (15 no medications, 15 angiotensin receptor blockers and 15 beta blockers) for at least 6 months will be assessed at baseline and after 12 weeks of combined exercise training.
| Arm | Type | Receives |
|---|---|---|
| No medication | Placebo comparator | Other: Combined exerciseGroup of pre-hypertensive women with no medication who practiced 12 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months |
| Angiotensin receptor blockers | Active comparator | Other: Combined exerciseGroup of hypertensive women taking Angiotensin receptor blockers who practiced 12 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months |
| Beta blockers | Active comparator | Other: Combined exerciseGroup of hypertensive women taking Beta blockers who practiced 12 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities. In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged between 50 and 70 years;
- Be in the postmenopausal phase;
- Be able to practice physical exercise on treadmill and bodybuilding,
- Receive a release certificate for exercise practice;
- Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises;
Key exclusion criteria (6 listed)
- Present history of stroke or acute myocardial infarction;
- Smokers;
- Present diagnosis of Diabetes Mellitus or renal pathologies;
- Use of antihypertensive drugs from classes that were not selected for this project;
- Make use of hormonal therapies;
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 |
|---|---|---|
| Combined exerciseThe program consisted of 36 sessions of combined aerobic and resistance exercises training during 12 consecutive weeks. Each session lasted 60 minutes and consisted of 30 minutes of resistance exercise and 30 minutes of aerobic exercise. The resistance training was performed in two sets of 8 to 12 repetitions in five exercises of weight training (Based on 1 repetition maximum test - 1RM). The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between 65 and 75% of maximun heart rate measured in maximum incremental test. Every week the resistance load and aerobic intensity was readjusted by determined training zone (8 to 12 maximum repetitions) and heart rate predicted in the incremental respectively. | Other | Angiotensin receptor blockers, Beta blockers, No medication |
Primary outcome
Changes in Ambulatorial Blood Pressure
Time frame: Before and within 72 hours after 12 weeks of exercise training
All volunteers were submitted to a 24-hour Blood Pressure (BP; systolic and diastolic measurements) assessment by Ambulatorial Blood Pressure Monitoring (ABPM) before and after 10 weeks of combined exercise training, with a minimum of 48 hours after the last training session. A device was used associated with a diary of examination to self-report of activities of daily living (sleep, work, food) or any event that could interfere abnormally with BP or device measurements. The device was always placed 7am and the measurements were made every 15 minutes from 7h to 23h and every 30 minutes from 23h to 7h. The monitoring was considered valid when it happened for a period of 24 hours. The following results were evaluated: systolic blood pressure; diastolic blood pressure, mean blood pressure and heart rate in awake, sleep and 24-hour periods. Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position.
5 secondary outcomes
Changes in Ambulatorial Blood Pressure Variability
Time frame: Before and within 72 hours after 12 weeks of exercise training
Changes in Heart Rate Variability
Time frame: Before and within 72 hours after 12 weeks of exercise training
Changes in salivary oxidative stress
Time frame: Before and within 72 hours after 12 weeks of exercise training
Changes of blood pressure reactivity
Time frame: Before and within 72 hours after 12 weeks of exercise training
Changes of Biochemical markers on blood
Time frame: Before and within 72 hours after 12 weeks of exercise training
Results and safety
The study was stopped early (reason given: Early interruption caused by the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 35465803Mariano IM, Amaral AL, V Carrijo VH, Costa JG, Rodrigues ML, Cunha TM, Puga GM. Different cardiovascular responses to exercise training in hypertensive women receiving beta-blockers or angiotensin receptor blockers: A pilot study. Clin Exp Hypertens. 2022 Jul 4;44(5):442-450. doi: 10.1080/10641963.2022.2065290. Epub 2022 Apr 23.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise in people with Hypertension and Menopause, run by Federal University of Uberlandia 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Early interruption caused by the COVID-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Ambulatorial Blood Pressure (time frame: Before and within 72 hours after 12 weeks of exercise training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03529838, which also lists 1 linked publication.
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 22 Mar 2022.