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Clinical Trials/NCT03942276
NCT03942276
Terminated
Not Applicable

Acute and Chronic Health Effects of Different Exercises Interventions in Post-menopausal Women: a Clinical, Controlled and Randomized Study

Federal University of Uberlandia1 site in 1 country60 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Federal University of Uberlandia
Enrollment
60
Locations
1
Primary Endpoint
Changes in Ambulatorial Blood Pressure
Status
Terminated
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of Uberlandia
Responsible Party
Principal Investigator
Principal Investigator

Igor Moraes Mariano

Principal investigator

Federal University of Uberlandia

Eligibility 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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in salivary oxidative stress (nM)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in Heart Rate Variability(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in Ambulatorial Blood Pressure Variability(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in salivary oxidative stress (units/mg prot)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in salivary oxidative stress (μmol H2O2/min/g prot)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in blood biomarkers (nM)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in Blood pressure reactivity(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in salivary oxidative stress (umol/L)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in blood biomarkers (umol/L)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in blood biomarkers (mg/dL)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in blood biomarkers (pg/mL)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in blood biomarkers (mg/L)(Before and within 72 hours after 12 weeks of exercise training/control)
  • Changes in blood biomarkers (Units/mg de prot)(Before and within 72 hours after 12 weeks of exercise training/control)

Study Sites (1)

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