HypertensionNCT03942276
Effects of Different Exercises Interventions in Post-menopausal Women
A study testing High intensity interval training and Moderate intensity continuous training in people with Hypertension and Menopause, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
This study will compare different exercise training protocols on health parameters of postmenopausal women. The hypothesis is that short duration high intensity interval training will promote different effects of long duration moderate intensity training. 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?
- High intensity interval training and Moderate intensity continuous training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 30 Sep 2020
- 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
- being postmenopausal (amenorrhea of at least 12 months and [FSH]> 40 mlU/ml); be controlled hypertension; not to undergo drug treatment with β-blockers; not make use of sex hormone therapies; do not present physical problems or cardiovascular complications that prevent the performance of physical exercises; present attestation of a cardiologist proving that they are able to perform physical exercises.
Who cannot join
- Do not attend the collection site on the day and time programmed more than once in the acute phase of the study; missing more than 2 consecutive sessions or 6 alternates in the chronic phase of the study; unable to perform the proposed training protocols; change in drug therapy during the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Chronic Health Effects of Different Exercises Interventions in Post-menopausal Women: a Clinical, Controlled and Randomized Study
This study will compare different exercise training protocols on health parameters of postmenopausal women. The hypothesis is that short duration high intensity interval training will promote different effects of long duration moderate intensity training.
Read the detailed description
Exercise load control still not a consensus as to the most effective strategy for improving health parameters in postmenopausal women. In this way, the volunteers will perform anthropometric and body composition assessments, climacteric symptoms and sleep quality evaluations, blood pressure reactivity, resting blood pressure and heart rate and ambulatorial blood pressure monitoring, before and after 12 weeks of training.
- Conditions
- Hypertension, Menopause
- Being tested
- High intensity interval training, Moderate intensity continuous training, Control
- Keywords
- Blood pressure, Menopause, Hypertension, Exercise, Alternative training
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
Also called Alternative aerobic exercise training
Consists of 60 seconds sets of high-intensity exercises, characterized by heart rate> 85% of maximal heart rate (HRmax), obtained through the formula (220-age), or by the Rated Perceived Exertion between 7 and 8 on the Borg scale, which ranges from 0 to 10. Of the 60 seconds of high intensity exercise, 30 seconds will be to get up and down a 16 cm step and 30 seconds of squats, with knee flexion greater than 90º, both at the highest possible speed. The recovery between sets is light walk for 60 seconds. If the volunteers do not reach the proposed intensity zone, they will be instructed to increase the number of squats and step ascents and descents.
Moderate intensity continuous trainingOther
Also called Traditional aerobic exercise training
Consist of performing a 30 minute walk at 50% of reserve heart rate (HRR), calculated by (HRmax - HRmax) x% + HRmax. HRmax being obtained by means of the formula (220 - age).
ControlOther
Consist of performing no exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Hypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks without perform exercise training. Receives: Other: Control |
| Alternative training | Experimental | Hypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks of high intensity interval training. Receives: Other: High intensity interval training |
| Conventional training | Experimental | Hypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks of moderate intensity continuous training Receives: Other: Moderate intensity continuous training |
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) 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 and mean blood pressure in awake, sleep and 24-hour periods, and shall be expressed in mmHg.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in Resting Blood Pressure
Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position. The following results were evaluated: systolic blood pressure; diastolic blood pressure and mean blood pressure, they shall be expressed in mmHg.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Secondary outcomes (13)
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/control
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/control
Changes in Blood pressure reactivity
To evaluate blood pressure reactivity under mental stress, it will be used the 3 minutes Stroop protocol of words and colors. The test consists of a video on a computer screen facing the volunteer that changes the image every 2 seconds. The volunteer should then speak as quickly as possible the color of the letters present on the screen, being that 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 ). At the end of the test, the volunteer demonstrates on a scale her difficulty in the test, according to the following classification: 0 = not stressful; 1 = slightly stressful; 3 = very stressful; and 4 = extremely stressful. Each minute of the test the blood pressure will be measured by auscultatory method, with stethoscope and mercury column, and the following results were evaluated: systolic blood pressure and diastolic blood pressure.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (umol/L)
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 and the 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 by the Bradford method, using bovine serum albumin (BSA) as standard. Expressed in umol/L. Expressed in umol/L.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (units/mg prot)
The salivary was collected after 12-hours fasting and the activity of the enzyme superoxide dismutase (SOD) was determined based on the auto oxidation capacity of pyrogallol. Expressed in Units/ mg prot.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (μmol H2O2/min/g prot)
The salivary was collected after 12-hours fasting and the catalase activity (CAT) was calculated by monitoring the consumption of hydrogen peroxide at 240 nm. Expressed in μmol H2O2/min/g prot.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (nM)
The salivary was collected after 12-hours fasting and the amounts of nitric oxide (NO) were estimated by the determination of total nitrite by the Griess colorimetric method. Expressed in nM.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (mg/dL)
Samples of fasting venous blood (12 hours) will be collected in a sterile environment, using disposable materials. After local asepsis, 15 mL of blood will be obtained. Blood samples will be deposited in test tubes containing EDTA and dried tubes with separator gel for collection of serum. The samples will then be centrifuged at 1500 rpm for 15 minutes to separate plasma and serum aliquots and stored at -80 ° C. Will be used commercial ELISA-specific kits In order to determine the activity of C-reactive protein (CRP), total cholesterol, triglycerides, HDL cholesterol (HDL-C), LDL cholesterol (LDL-C) and Tryglicerides, all express in mg/dL. VLDL will be calculated using the equation suggested by the Brazilian Society of Cardiology, dividing the concentration of triglycerides by 5.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (nM)
Samples of fasting venous blood (12 hours) will be collected in a sterile environment, using disposable materials. After local asepsis, 15 mL of blood will be obtained. Blood samples will be deposited in test tubes containing EDTA and dried tubes with separator gel for collection of serum. The samples will then be centrifuged at 1500 rpm for 15 minutes to separate plasma and serum aliquots and stored at -80 ° C. Will be used commercial ELISA-specific kits In order to determine the activity of nitrite (NO-2) and nitrate (NO-3), expressed in nM.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (pg/mL)
Samples of fasting venous blood (12 hours) will be collected in a sterile environment, using disposable materials. After local asepsis, 15 mL of blood will be obtained. Blood samples will be deposited in test tubes containing EDTA and dried tubes with separator gel for collection of serum. The samples will then be centrifuged at 1500 rpm for 15 minutes to separate plasma and serum aliquots and stored at -80 ° C. Will be used commercial ELISA-specific kits In order to determine the activity of Interleukin-6 (IL-6), Interleukin-10 (IL-10) and Tumor Necrosis Factor α (TNFα), expressed in pg/mL.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (mg/L)
Samples of fasting venous blood (12 hours) will be collected in a sterile environment, using disposable materials. After local asepsis, 15 mL of blood will be obtained. Blood samples will be deposited in test tubes containing EDTA and dried tubes with separator gel for collection of serum. The samples will then be centrifuged at 1500 rpm for 15 minutes to separate plasma and serum aliquots and stored at -80 ° C. Will be used commercial ELISA-specific kits In order to determine the activity of Adiponectin concentration, expressed in mg/L.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (Units/mg de prot)
Samples of fasting venous blood (12 hours) will be collected in a sterile environment, using disposable materials. After local asepsis, 15 mL of blood will be obtained. Blood samples will be deposited in test tubes containing EDTA and dried tubes with separator gel for collection of serum. The samples will then be centrifuged at 1500 rpm for 15 minutes to separate plasma and serum aliquots and stored at -80 ° C. Will be used commercial ELISA-specific kits In order to determine the activity of Superoxide Dismutase (SOD) and Catalase (CAT), expressed in Units/mg de prot.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (umol/L)
Samples of fasting venous blood (12 hours) will be collected in a sterile environment, using disposable materials. After local asepsis, 15 mL of blood will be obtained. Blood samples will be deposited in test tubes containing EDTA and dried tubes with separator gel for collection of serum. The samples will then be centrifuged at 1500 rpm for 15 minutes to separate plasma and serum aliquots and stored at -80 ° C. Will be used commercial ELISA-specific kits In order to determine the activity of Thiobarbituric Acid (TBARS), expressed in umol/L.
Measured: Before and within 72 hours after 12 weeks of exercise training/control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Sep 2019
- Primary completion31 Mar 2020
- Study completion30 Sep 2020
Why it stopped: Participants constantly reported knee pain.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT03942276
- Sponsor's protocol ID
- CEP UFU 07839218.8.0000.5152
- Status last verified
- Jan 2021
- First submitted
- 24 Apr 2019
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Health Effects of Different Exercises Interventions in Post-menopausal Women: a Clinical, Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT03942276
- Acronym / sponsor ID
- CEP UFU 07839218.8.0000.5152
- Conditions
- Hypertension, Menopause
- Keywords
- Blood pressure, Menopause, Hypertension, Exercise, Alternative training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participants constantly reported knee pain.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 8 May 2019 (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.
This study will compare different exercise training protocols on health parameters of postmenopausal women. The hypothesis is that short duration high intensity interval training will promote different effects of long duration moderate intensity training.
Detailed description
Exercise load control still not a consensus as to the most effective strategy for improving health parameters in postmenopausal women. In this way, the volunteers will perform anthropometric and body composition assessments, climacteric symptoms and sleep quality evaluations, blood pressure reactivity, resting blood pressure and heart rate and ambulatorial blood pressure monitoring, before and after 12 weeks of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlHypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks without perform exercise training. |
| Alternative training | Experimental | Other: High intensity interval trainingHypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks of high intensity interval training. |
| Conventional training | Experimental | Other: Moderate intensity continuous trainingHypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks of moderate intensity continuous training |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- being postmenopausal (amenorrhea of at least 12 months and [FSH]> 40 mlU/ml); be controlled hypertension; not to undergo drug treatment with β-blockers; not make use of sex hormone therapies; do not present physical problems or cardiovascular complications that prevent the performance of physical exercises; present attestation of a cardiologist proving that they are able to perform physical exercises.
Key exclusion criteria (1 listed)
- Do not attend the collection site on the day and time programmed more than once in the acute phase of the study; missing more than 2 consecutive sessions or 6 alternates in the chronic phase of the study; unable to perform the proposed training protocols; change in drug therapy during the intervention.
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 |
|---|---|---|
| High intensity interval trainingAlso: Alternative aerobic exercise trainingConsists of 60 seconds sets of high-intensity exercises, characterized by heart rate> 85% of maximal heart rate (HRmax), obtained through the formula (220-age), or by the Rated Perceived Exertion between 7 and 8 on the Borg scale, which ranges from 0 to 10. Of the 60 seconds of high intensity exercise, 30 seconds will be to get up and down a 16 cm step and 30 seconds of squats, with knee flexion greater than 90º, both at the highest possible speed. The recovery between sets is light walk for 60 seconds. If the volunteers do not reach the proposed intensity zone, they will be instructed to increase the number of squats and step ascents and descents. | Other | Alternative training |
| Moderate intensity continuous trainingAlso: Traditional aerobic exercise trainingConsist of performing a 30 minute walk at 50% of reserve heart rate (HRR), calculated by (HRmax - HRmax) x% + HRmax. HRmax being obtained by means of the formula (220 - age). | Other | Conventional training |
| ControlConsist of performing no exercise training. | Other | Control |
Primary outcome
Changes in Ambulatorial Blood Pressure
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
All volunteers were submitted to a 24-hour Blood Pressure (BP) 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 and mean blood pressure in awake, sleep and 24-hour periods, and shall be expressed in mmHg.
Changes in Resting Blood Pressure
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position. The following results were evaluated: systolic blood pressure; diastolic blood pressure and mean blood pressure, they shall be expressed in mmHg.
13 secondary outcomes
Changes in Heart Rate Variability
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in Ambulatorial Blood Pressure Variability
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in Blood pressure reactivity
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (umol/L)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (units/mg prot)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (μmol H2O2/min/g prot)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in salivary oxidative stress (nM)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (mg/dL)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (nM)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (pg/mL)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (mg/L)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (Units/mg de prot)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Changes in blood biomarkers (umol/L)
Time frame: Before and within 72 hours after 12 weeks of exercise training/control
Results and safety
The study was stopped early (reason given: Participants constantly reported knee pain.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- 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 High intensity interval training and Moderate intensity continuous training 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 1 inclusion and 1 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 11 Jan 2021. 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: Participants constantly reported knee pain.). 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/control). The study lists 2 primary outcomes in all. 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 11 Jan 2021.