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Effects of Different Exercises Interventions in Post-menopausal Women

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ClinicalTrials.gov Identifier: NCT03942276
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Igor Moraes Mariano, Federal University of Uberlandia

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Menopause Other: High intensity interval training Other: Moderate intensity continuous training Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute and Chronic Health Effects of Different Exercises Interventions in Post-menopausal Women: a Clinical, Controlled and Randomized Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Hypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks without perform exercise training.
Other: Control
Consist of performing no exercise training.

Experimental: Alternative training
Hypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks of high intensity interval training.
Other: High intensity interval 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.
Other Name: Alternative aerobic exercise training

Experimental: Conventional training
Hypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks of moderate intensity continuous training
Other: Moderate intensity continuous 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).
Other Name: Traditional aerobic exercise training




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Changes in Heart Rate Variability [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  2. Changes in Ambulatorial Blood Pressure Variability [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  3. Changes in Blood pressure reactivity [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  4. Changes in salivary oxidative stress (umol/L) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  5. Changes in salivary oxidative stress (units/mg prot) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  6. Changes in salivary oxidative stress (μmol H2O2/min/g prot) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  7. Changes in salivary oxidative stress (nM) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  8. Changes in blood biomarkers (mg/dL) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  9. Changes in blood biomarkers (nM) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  10. Changes in blood biomarkers (pg/mL) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  11. Changes in blood biomarkers (mg/L) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  12. Changes in blood biomarkers (Units/mg de prot) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.

  13. Changes in blood biomarkers (umol/L) [ Time Frame: Before and within 72 hours after 12 weeks of exercise training/control ]
    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.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942276


Locations
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Brazil
Guilherme Morais Puga
Uberlandia, Minas Gerais, Brazil, 38400-678
Sponsors and Collaborators
Federal University of Uberlandia

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Responsible Party: Igor Moraes Mariano, Principal investigator, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03942276    
Other Study ID Numbers: CEP UFU 07839218.8.0000.5152
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Igor Moraes Mariano, Federal University of Uberlandia:
Blood pressure
Menopause
Hypertension
Exercise
Alternative training
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases