Effects of Different Exercises Interventions in Post-menopausal Women

NCT03942276 | Terminated DMC

• 1 other identifier: CEP UFU 07839218.8.0000.5152
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Menopause

Keywords

Blood pressure; Menopause; Hypertension; Exercise; Alternative training

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Before and within 72 hours after 12 weeks of exercise training/control

Secondary Outcomes (13)

• 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 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 salivary oxidative stress (units/mg prot)

  Before and within 72 hours after 12 weeks of exercise training/control

Study Arms (3)

Control

PLACEBO COMPARATOR

Hypertensive post menopausal women, who will do the evaluations before the beginning and after 12 weeks without perform exercise training.

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.

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

Other: Moderate intensity continuous training

Interventions

High intensity interval training OTHER

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.

Also known as: Alternative aerobic exercise training

Alternative training

Moderate intensity continuous training OTHER

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).

Also known as: Traditional aerobic exercise training

Conventional training

Control OTHER

Consist of performing no exercise training.

Control

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Guilherme Morais Puga

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 8, 2019
• Study Start: September 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: September 30, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

BR (1)